NDC 0378-0924

Buprenorphine Hydrochloride Sublingual

Buprenorphine Hydrochloride Sublingual

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

• Product ID: 0378-0924_140de61a-37dc-465e-a4c6-35b605b918a8
• NDC: 0378-0924
• Product Type: Human Prescription Drug
• Proprietary Name: Buprenorphine Hydrochloride Sublingual
• Generic Name: Buprenorphine Hydrochloride Sublingual
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2015-03-06
• Marketing End Date: 2019-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201066
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: BUPRENORPHINE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N

Packaging

NDC 0378-0924-93

30 TABLET in 1 BOTTLE, PLASTIC (0378-0924-93)

• Marketing Start Date: 2015-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0924-05 [00378092405]

Buprenorphine Hydrochloride Sublingual TABLET

• Marketing Category: ANDA
• Application Number: ANDA201066
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-06
• Marketing End Date: 2016-04-15

NDC 0378-0924-93 [00378092493]

Buprenorphine Hydrochloride Sublingual TABLET

• Marketing Category: ANDA
• Application Number: ANDA201066
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-06
• Marketing End Date: 2019-10-31

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 7a85f424-9d83-49d9-8a17-478abce6fddd
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351265
  • 351264

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0378-0923	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual
0378-0924	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual
67046-996	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual
67046-997	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual
70518-0652	Buprenorphine Hydrochloride Sublingual	buprenorphine hydrochloride sublingual