NDC 0095-3000

BUPAP

Butalbital And Acetaminophen Tablets

BUPAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Butalbital; Acetaminophen.

• Product ID: 0095-3000_16609ec3-578a-4f92-83d4-85d58e23cd8d
• NDC: 0095-3000
• Product Type: Human Prescription Drug
• Proprietary Name: BUPAP
• Generic Name: Butalbital And Acetaminophen Tablets
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090956
• Labeler Name: Bausch Health US, LLC
• Substance Name: BUTALBITAL; ACETAMINOPHEN
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: Barbiturates [CS],Barbiturate [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0095-3000-01

100 TABLET in 1 BOTTLE, PLASTIC (0095-3000-01)

• Marketing Start Date: 2013-06-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0095-3000-01 [00095300001]

BUPAP TABLET

• Marketing Category: ANDA
• Application Number: ANDA090956
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-06-24

NDC 0095-3000-09 [00095300009]

BUPAP TABLET

• Marketing Category: ANDA
• Application Number: ANDA090956
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-06-24

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 30e483da-eaf1-4c73-9fed-333337f9ba86
• Manufacturer:
  • ECR Pharmaceuticals
• UNII:
  • KHS0AZ4JVK
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 1249617
  • 1428622

Pharmacological Class

• Barbiturates [CS]
• Barbiturate [EPC]

NDC Crossover Matching brand name "BUPAP" or generic name "Butalbital And Acetaminophen Tablets"

NDC	Brand Name	Generic Name
0095-3000	BUPAP	Butalbital and Acetaminophen Tablets
68682-306	Butalbital and Acetaminophen	Butalbital and Acetaminophen tablets