NDC 76519-1160

NALTREXONE HYDROCHLORIDE

Naltrexone Hydrochloride

NALTREXONE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Naltrexone Hydrochloride.

• Product ID: 76519-1160_5f256d4f-450a-87c7-e053-2a91aa0a79ef
• NDC: 76519-1160
• Product Type: Human Prescription Drug
• Proprietary Name: NALTREXONE HYDROCHLORIDE
• Generic Name: Naltrexone Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075274
• Labeler Name: H.J. Harkins Company Inc.
• Substance Name: NALTREXONE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76519-1160-5

15 TABLET, FILM COATED in 1 CONTAINER (76519-1160-5)

• Marketing Start Date: 2017-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76519-1160-5 [76519116005]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075274
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: 5f256d4f-4509-87c7-e053-2a91aa0a79ef
• Manufacturer:
  • H.J. Harkins Company Inc.
• UNII:
  • Z6375YW9SF
• RxNorm Concept Unique ID - RxCUI:
  • 1483744

Pharmacological Class

• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]

NDC Crossover Matching brand name "NALTREXONE HYDROCHLORIDE" or generic name "Naltrexone Hydrochloride"

NDC	Brand Name	Generic Name
0406-1170	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride
0904-7036	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
16729-081	Naltrexone Hydrochloride	Naltrexone Hydrochloride
42291-632	Naltrexone Hydrochloride	Naltrexone Hydrochloride
47335-326	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
50090-2866	Naltrexone Hydrochloride	Naltrexone Hydrochloride
50090-3076	Naltrexone Hydrochloride	Naltrexone Hydrochloride
50090-3929	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
50090-4925	Naltrexone Hydrochloride	Naltrexone Hydrochloride
50090-4926	Naltrexone Hydrochloride	Naltrexone Hydrochloride
51224-206	Naltrexone Hydrochloride	Naltrexone Hydrochloride
53217-261	Naltrexone Hydrochloride	Naltrexone Hydrochloride
62135-242	Naltrexone Hydrochloride	Naltrexone Hydrochloride
63629-1046	Naltrexone Hydrochloride	Naltrexone Hydrochloride
63629-1047	Naltrexone Hydrochloride	Naltrexone Hydrochloride
68071-2156	Naltrexone Hydrochloride	Naltrexone Hydrochloride
68071-2721	Naltrexone Hydrochloride	Naltrexone Hydrochloride
68084-291	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride
68094-853	Naltrexone Hydrochloride	naltrexone Hydrochloride
68788-7084	Naltrexone Hydrochloride	Naltrexone Hydrochloride
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride
70518-1312	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride
70518-2718	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
71335-0014	Naltrexone Hydrochloride	Naltrexone Hydrochloride
76519-1160	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE
71335-1480	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE