NDC 53217-261

Naltrexone Hydrochloride

Naltrexone Hydrochloride

Naltrexone Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Naltrexone Hydrochloride.

• Product ID: 53217-261_9f0d222c-f87f-486b-b186-b09b1173fc9b
• NDC: 53217-261
• 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: 2013-09-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075274
• Labeler Name: Aidarex Pharmaceuticals LLC
• 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 53217-261-30

30 TABLET, FILM COATED in 1 BOTTLE (53217-261-30)

• Marketing Start Date: 2013-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53217-261-30 [53217026130]

Naltrexone Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075274
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-23
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: f58d9be1-a428-45df-9c0b-369e93e71c6a
• Manufacturer:
  • Aidarex Pharmaceuticals LLC
• 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