NDC 67046-997

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 Contract Pharmacy Services-pa. The primary component is Buprenorphine Hydrochloride.

• Product ID: 67046-997_593c2a50-de50-6bf8-e053-2a91aa0ae306
• NDC: 67046-997
• 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 Category: ANDA / ANDA
• Application Number: ANDA201066
• Labeler Name: Contract Pharmacy Services-PA
• 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 67046-997-30

30 TABLET in 1 BLISTER PACK (67046-997-30)

• Marketing Start Date: 2017-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67046-997-30 [67046099730]

Buprenorphine Hydrochloride Sublingual TABLET

• Marketing Category: ANDA
• Application Number: ANDA201066
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-15

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 593c2a50-de4f-6bf8-e053-2a91aa0ae306
• Manufacturer:
  • Contract Pharmacy Services-PA
• UNII:
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351265
  • 351264
• UPC Code:
  • 0303780924932
  • 0303780923935

Pharmacological Class

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