NDC 0228-3156

Buprenorphine

Buprenorphine

Buprenorphine is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Buprenorphine Hydrochloride.

• Product ID: 0228-3156_01763a3b-afc8-4551-b9d5-f8d8ff2801b8
• NDC: 0228-3156
• Product Type: Human Prescription Drug
• Proprietary Name: Buprenorphine
• Generic Name: Buprenorphine
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2015-02-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090819
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: BUPRENORPHINE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0228-3156-03

30 TABLET in 1 BOTTLE (0228-3156-03)

• Marketing Start Date: 2015-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0228-3156-09 [00228315609]

Buprenorphine TABLET

• Marketing Category: ANDA
• Application Number: ANDA090819
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-19
• Marketing End Date: 2015-02-19

NDC 0228-3156-03 [00228315603]

Buprenorphine TABLET

• Marketing Category: ANDA
• Application Number: ANDA090819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-10

NDC 0228-3156-73 [00228315673]

Buprenorphine TABLET

• Marketing Category: ANDA
• Application Number: ANDA090819
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-19
• Marketing End Date: 2015-02-19

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 03819118-86f6-4329-adaf-4599e7b71f46
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351265
  • 351264
• UPC Code:
  • 0302283156031
  • 0302283153030

Pharmacological Class

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

NDC Crossover Matching brand name "Buprenorphine" or generic name "Buprenorphine"

NDC	Brand Name	Generic Name
0093-3239	Buprenorphine	Buprenorphine
0093-3600	Buprenorphine	Buprenorphine
0093-3601	Buprenorphine	Buprenorphine
0093-3602	Buprenorphine	Buprenorphine
0093-3603	Buprenorphine	Buprenorphine
0093-3656	Buprenorphine	Buprenorphine
0093-3657	Buprenorphine	Buprenorphine
0093-3658	Buprenorphine	Buprenorphine
0093-3659	Buprenorphine	Buprenorphine
0228-3153	Buprenorphine	Buprenorphine
0228-3156	Buprenorphine	Buprenorphine
70518-0711	Buprenorphine	Buprenorphine
70518-1557	Buprenorphine	Buprenorphine
70518-1625	Buprenorphine	Buprenorphine
71335-0353	Buprenorphine	Buprenorphine
71335-0950	BUPRENORPHINE	BUPRENORPHINE
42858-586	Buprenorphine	Buprenorphine
42858-750	Buprenorphine	Buprenorphine
42858-502	BUPRENORPHINE	BUPRENORPHINE
42858-501	BUPRENORPHINE	BUPRENORPHINE
42858-353	Buprenorphine	Buprenorphine
42858-839	Buprenorphine	Buprenorphine
42858-493	Buprenorphine	Buprenorphine
50090-2924	Buprenorphine	Buprenorphine
55700-579	Buprenorphine	Buprenorphine
55700-568	Buprenorphine	Buprenorphine
58118-3156	Buprenorphine	Buprenorphine
62756-459	Buprenorphine	Buprenorphine
62756-460	Buprenorphine	Buprenorphine
67046-994	Buprenorphine	Buprenorphine
67046-995	Buprenorphine	Buprenorphine
71335-1154	BUPRENORPHINE	BUPRENORPHINE
70518-2218	BUPRENORPHINE	BUPRENORPHINE
70518-2217	BUPRENORPHINE	BUPRENORPHINE