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ascorbic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4072	50-81-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: vitamin c L-Ascorbic acid ascorbic acid ascorbic acid (vit C) sodium ascorbate calcium ascorbate ascorbic acid, monosodium salt	A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant. NIH COVID-19 Treatment Guidelines Panel states that there are insufficient data to recommend either for or against use of ascorbic acid for the treatment of COVID-19 in critically or noncritically ill patients. Molecular weight: 176.12 Formula: C6H8O6 CLOGP: -1.76 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 107.22 ALOGS: 0.14 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

vitamin c
L-Ascorbic acid
ascorbic acid
ascorbic acid (vit C)
sodium ascorbate
calcium ascorbate
ascorbic acid, monosodium salt

A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant. NIH COVID-19 Treatment Guidelines Panel states that there are insufficient data to recommend either for or against use of ascorbic acid for the treatment of COVID-19 in critically or noncritically ill patients.

Molecular weight: 176.12
Formula: C6H8O6
CLOGP: -1.76
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 107.22
ALOGS: 0.14
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.20	g	O
0.20	g	P
0.25	g	V

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	567.77 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	333 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	25 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	11.40 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.05 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.35 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.26 %	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	0	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
None	FDA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigus	1278.90	10.76	4420	636337	179306	62668959
Systemic lupus erythematosus	1187.69	10.76	4708	636049	204210	62644055
Completed suicide	1161.73	10.76	79	640678	145594	62702671
Glossodynia	1057.72	10.76	4082	636675	174794	62673471
Toxicity to various agents	891.66	10.76	713	640044	246537	62601728
Hand deformity	846.34	10.76	3519	637238	155938	62692327
Arthropathy	826.83	10.76	4603	636154	230189	62618076
Abdominal discomfort	788.12	10.76	5739	635018	315146	62533119
Alopecia	759.23	10.76	5913	634844	331623	62516642
Rheumatoid arthritis	734.28	10.76	4727	636030	249092	62599173

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Rheumatoid arthritis	448.58	10.28	861	229935	37377	34688758
Toxicity to various agents	426.23	10.28	417	230379	199945	34526190
Drug abuse	367.09	10.28	100	230696	98996	34627139
Completed suicide	352.66	10.28	105	230691	98063	34628072
Drug interaction	273.49	10.28	687	230109	225259	34500876
Arthralgia	210.08	10.28	1874	228922	168167	34557968
Foetal exposure during pregnancy	183.95	10.28	612	230184	37489	34688646
Psoriatic arthropathy	172.69	10.28	395	230401	19403	34706732
Intentional overdose	147.40	10.28	52	230744	43622	34682513
Joint swelling	135.57	10.28	765	230031	59125	34667010

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	1428.78	10.09	181	663724	245586	78834897
Toxicity to various agents	1242.50	10.09	1013	662892	420527	78659956
Rheumatoid arthritis	1070.04	10.09	3989	659916	204481	78876002
Joint swelling	842.41	10.09	4674	659231	283972	78796511
Drug abuse	826.51	10.09	173	663732	162518	78917965
Arthropathy	763.98	10.09	3210	660695	173901	78906582
Drug interaction	735.26	10.09	1467	662438	413716	78666767
Pemphigus	693.23	10.09	2112	661793	97470	78983013
Systemic lupus erythematosus	681.94	10.09	2390	661515	118759	78961724
Hand deformity	670.82	10.09	2147	661758	101772	78978711

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A11GA01	ALIMENTARY TRACT AND METABOLISM VITAMINS ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS Ascorbic acid (vitamin C), plain
ATC	A11GB01	ALIMENTARY TRACT AND METABOLISM VITAMINS ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS Ascorbic acid (vitamin C), combinations
ATC	G01AD03	GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Organic acids
ATC	S01XA15	SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals
CHEBI has role	CHEBI:23354	coenzymes
CHEBI has role	CHEBI:23357	cofactor
CHEBI has role	CHEBI:64577	dough improvers
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77962	food antioxidants
CHEBI has role	CHEBI:85046	skin lightening agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Ascorbic acid deficiency	indication	76169001
Breastfeeding (mother)	indication	413712001
Coronavirus infection	off-label use	186747009
Anuria	contraindication	2472002	DOID:2983
Hypocalcemia	contraindication	5291005
Peptic ulcer	contraindication	13200003	DOID:750
Hyperkalemia	contraindication	14140009
Severe chronic ulcerative colitis	contraindication	14311001
Constipation	contraindication	14760008	DOID:2089
Operation on stomach	contraindication	16453004

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.02	acidic
pKa2	9.62	acidic
pKa3	11.85	acidic
pKa4	12.53	acidic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	PLENVU	SALIX	N209381	May 4, 2018	RX	FOR SOLUTION	ORAL	10792306	March 9, 2032	FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	PLENVU	SALIX	N209381	May 4, 2018	RX	FOR SOLUTION	ORAL	11529368	March 9, 2032	FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	PLENVU	SALIX	N209381	May 4, 2018	RX	FOR SOLUTION	ORAL	9592252	Aug. 11, 2032	FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	PLENVU	SALIX	N209381	May 4, 2018	RX	FOR SOLUTION	ORAL	10918723	Sept. 10, 2033	FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	PLENVU	SALIX	N209381	May 4, 2018	RX	FOR SOLUTION	ORAL	9326969	Sept. 10, 2033	FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
25,000MG/50ML (500MG/ML)	ASCOR	MCGUFF	N209112	Oct. 2, 2017	RX	SOLUTION	INTRAVENOUS	Oct. 2, 2024	FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Tyrosinase	Enzyme	P14679	TYRO_HUMAN	IC50	4.49	CHEMBL
Prolyl 4-hydroxylase subunit alpha-1	Enzyme	P13674	P4HA1_HUMAN			WOMBAT-PK
Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1	Enzyme	Q02809	PLOD1_HUMAN			WOMBAT-PK
Solute carrier family 23 member 2	Transporter	Q9UGH3	S23A2_HUMAN			WOMBAT-PK
Solute carrier family 23 member 1	Transporter	Q9UHI7	S23A1_HUMAN			WOMBAT-PK
Urease	Enzyme		UREA_CANEN	IC50	5.07	CHEMBL
Pancreatic alpha-amylase	Enzyme		AMYP_RAT	IC50	4.58	CHEMBL

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External reference:

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ID	Source
ASC	PDB_CHEM_ID
001010	NDDF
001011	NDDF
001012	NDDF
1132	MMSL
1151	RXNORM
11881	MMSL
126230002	SNOMEDCT_US
126231003	SNOMEDCT_US
134-03-2	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Antiflu Kids	HUMAN OTC DRUG LABEL	3	0280-0046	POWDER, FOR SOLUTION	50 mg	ORAL	Export only	2 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	19	0682-3001	TABLET, COATED	500 mg	ORAL	UNAPPROVED DRUG OTHER	10 sections
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	120 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN PRESCRIPTION DRUG LABEL	16	0178-0821	TABLET	120 mg	ORAL	unapproved drug other	11 sections
CitraNatal 90 DHA	HUMAN OTC DRUG LABEL	14	0178-0829	TABLET	120 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	138 mg	ORAL	unapproved drug other	15 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	138 mg	ORAL	unapproved drug other	15 sections
CitraNatal Bloom	HUMAN PRESCRIPTION DRUG LABEL	6	0178-0813	TABLET, FILM COATED	138 mg	ORAL	unapproved drug other	15 sections
CitraNatal DHA	HUMAN OTC DRUG LABEL	14	0178-0898	TABLET	120 mg	ORAL	Unapproved drug other	11 sections
CitraNatal Rx	HUMAN PRESCRIPTION DRUG LABEL	13	0178-0858	TABLET	120 mg	ORAL	Unapproved drug other	12 sections

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