NDC 0054-0189

buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

buprenorphine hydrochloride and naloxone hydrochloride dihydrate is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

• Product ID: 0054-0189_019288c8-bfb7-41d6-ad88-e608b8174bdf
• NDC: 0054-0189
• Product Type: Human Prescription Drug
• Proprietary Name: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
• Generic Name: Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2014-06-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203326
• Labeler Name: Hikma Pharmaceuticals USA Inc.
• Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0054-0189-13

30 TABLET in 1 BOTTLE (0054-0189-13)

• Marketing Start Date: 2014-06-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0189-13 [00054018913]

buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET

• Marketing Category: ANDA
• Application Number: ANDA203326
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-27

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 713db2c6-0544-4633-b874-cfbeaf93db89
• Manufacturer:
  • West-Ward Pharmaceuticals Corp
• UNII:
  • 5Q187997EE
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351267
  • 351266

Pharmacological Class

• Partial Opioid Agonists [MoA]
• Partial Opioid Agonist [EPC]
• Opioid Antagonist [EPC]
• Opioid Antagonists [MoA]

NDC Crossover Matching brand name "buprenorphine hydrochloride and naloxone hydrochloride dihydrate" or generic name "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate"

NDC	Brand Name	Generic Name
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0406-8005	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0406-8020	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0904-7009	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0904-7010	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
16729-549	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
16729-550	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
71335-1653	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
71335-1725	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
71335-1720	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate