Details of the Drug Formulations

General Information of Drug (ID: DMUL45H)

• Drug Name: Naltrexone Drug Info
• Synonyms: Depotrex; Naltrel; Vivitrex; Vivitrol; Naltrexone Depot; IBS therapy, Pain Therapeutics; Irritable bowel syndrome therapy, Pain Therapeutics; PTI-901; XR-NTX; Naltrexone (sustained release), DAS; Naltrexone (sustained release), elbion; Naltrexone depot (injectable suspension), DrugAbuse Sciences; Naltrexone depot (injectable suspension), elbion; Opioid antagonists (irritable bowel syndrome), Pain Therapeutics; Naltrexone (low-dose), Pain Therapeutics; Naltrexone (polymer microcapsule depot, opioid addiction/alcohol dependency), Biotek; Naltrexone (transdermal, alcohol/opioid dependence), Syntropharma; Naltrexone (once-monthly controlled-release, Medisorb), Alkermes

Indication

Disease Entry	ICD 11	Status	REF
Alcohol dependence	6C40.2	Approved	[1]
Chronic alcoholism	6C40.2Z	Approved	[2]
Crohn disease	DD70	Approved	[3]
Gastroparesis	DA41.00	Approved	[3]
Inflammatory bowel disease	DD72	Approved	[3]
Obesity	5B81	Approved	[3]
Ulcerative colitis	DD71	Approved	[3]
Human immunodeficiency virus infection	1C62	Phase 4	[4]
Coronavirus Disease 2019 (COVID-19)	1D6Y	Phase 2	[5]
Chronic pain	MG30	Investigative	[3]

• Cross-matching ID:
  PubChem CID: 5360515
  ChEBI ID: CHEBI:7465
  CAS Number: 16590-41-3
  TTD ID: D0PG8O
  VARIDT ID: DR00968
  INTEDE ID: DR1128
  ACDINA ID: D00455

Full List of Drug Formulations Containing This Drug

Naltrexone Hydrochloride 0.8mg extended release capsule

Company	Formulation ID	FDA Description
Aharma Pharms	F24301	Talc; Ammonio Methacrylate Copolymer; Sugar Spheres; Ethylcellulose; Sodium Chloride; Polyethylene Glycol; Hydroxypropyl Cellulose; Dibutyl Sebacate; Methacrylic Acid Copolymer; Diethyl Phthalate; Magnesium Stearate; Sodium Lauryl Sulfate; Ascorbic Acid; Gelatin; Titanium Dioxide; Grey Ink; Fd&C Yellow 10; Fd&C Red 3; Fd&C Blue 1; D&C Red 28; Fd&C Red 40; Fd&C Blue 1; D&C Red 28; Fd&C Red 40; Fd&C Blue 1; Fd&C Blue 1; Fd&C Red 40; Fd&C Yellow 6; D&C Yellow 10; Fd&C Blue 1

Naltrexone Hydrochloride 20mg extended release capsule

Company	Formulation ID	FDA Description
Aharma Pharms	F24364	Talc; Ammonio Methacrylate Copolymer; Sugar Spheres; Ethylcellulose; Sodium Chloride; Polyethylene Glycol; Hydroxypropyl Cellulose; Dibutyl Sebacate; Methacrylic Acid Copolymer; Diethyl Phthalate; Magnesium Stearate; Sodium Lauryl Sulfate; Ascorbic Acid; Gelatin; Titanium Dioxide; Grey Ink; Fd&C Yellow 10; Fd&C Red 3; Fd&C Blue 1; D&C Red 28; Fd&C Red 40; Fd&C Blue 1; D&C Red 28; Fd&C Red 40; Fd&C Blue 1; Fd&C Blue 1; Fd&C Red 40; Fd&C Yellow 6; D&C Yellow 10; Fd&C Blue 1

Naltrexone Hydrochloride 8mg extended release tablet

Company	Formulation ID	FDA Description
Naropion	F24422	Microcrystalline Cellulose; Hydroxypropyl Cellulose; Lactose Anhydrous; L-Cysteine Hydrochloride; Crospovidone; Magnesium Stearate; Hypromellose; Edetate Disodium; Lactose Monohydrate; Colloidal Silicon Dioxide; Opadry Ii Blue; Fd&C Blue 2 Aluminum Lake

Naltrexone Hydrochloride 90mg extended release tablet

Company	Formulation ID	FDA Description
Naropion	F24423	Microcrystalline Cellulose; Hydroxypropyl Cellulose; Lactose Anhydrous; L-Cysteine Hydrochloride; Crospovidone; Magnesium Stearate; Hypromellose; Edetate Disodium; Lactose Monohydrate; Colloidal Silicon Dioxide; Opadry Ii Blue; Fd&C Blue 2 Aluminum Lake

Naltrexone Hydrochloride 50mg tablet

Company	Formulation ID	FDA Description
Teva Womens	F23492	Colloidal Silicon Dioxide; Crospovidone; Hydroxypropyl Methylcellulose; Lactose Monohydrate; Magnesium Stearate; Microcrystalline Cellulose; Polyethylene Glycol; Polysorbate 80; Synthetic Red Iron Oxide; Synthetic Yellow Iron Oxide; Titanium Dioxide

Naltrexone 50 mg tablet

Company	Formulation ID	FDA Description
RemedyRepack	F14855	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
Sun Pharmaceutical Industries	F14858	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (6 mpa.s)
Barr Laboratories; Bryant Ranch Prepack; Teva Women's Health	F14860	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (3 mpa.s); Hypromellose 2910 (6 mpa.s)
Accord Healthcare	F14861	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
American Health Packaging; PD-Rx Pharmaceuticals	F14857	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Physicians Total Care	F14862	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycol
PD-Rx Pharmaceuticals; Unit Dose Services	F14863	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Crospovidone; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Eon Labs	F14859	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Crospovidone; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2208 (100 mpa.s); Polyethylene glycols
Mallinckrodt	F14856	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Titanium dioxide; Polysorbate 80; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromelloses; Polyethylene glycols
Aidarex Pharmaceuticals; AvKARE; Avera McKennan Hospital; NuCare Pharmaceuticals; Precision Dose	F14854	Anhydrous lactose; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Hydroxypropyl cellulose (type h); Hypromelloses; Polyethylene glycols
TAGI Pharma	F14864	Anhydrous lactose; Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Silicon dioxide; Hydroxypropyl cellulose (1200000 mw); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified

References

• [1] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
• [2] FDA Approved Drug Products from FDA Official Website. 2019. Application Number: (ANDA) 074918.
• [3] Naltrexone FDA Label
• [4] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 1639).
• [5] ClinicalTrials.gov (NCT04365985) Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19. U.S. National Institutes of Health.