NDC 0904-7036

NALTREXONE HYDROCHLORIDE

Naltrexone Hydrochloride

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

Product ID0904-7036_69cb8573-08c1-4957-a768-6cd383f6a3f4
NDC0904-7036
Product TypeHuman Prescription Drug
Proprietary NameNALTREXONE HYDROCHLORIDE
Generic NameNaltrexone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-29
Marketing CategoryANDA / ANDA
Application NumberANDA090356
Labeler NameMajor Pharmaceuticals
Substance NameNALTREXONE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0904-7036-04

30 BLISTER PACK in 1 CARTON (0904-7036-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-7036-04 [00904703604]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

Drug Details

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.