NDC 70010-044

Butalbita,Acetaminophen and Caffeine

Butalbita,acetaminophen And Caffeine

Butalbita,Acetaminophen and Caffeine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Granules Pharmaceuticals Inc.. The primary component is Butalbital; Acetaminophen; Caffeine.

• Product ID: 70010-044_a2d6a7af-0570-064b-e053-2a95a90a0a83
• NDC: 70010-044
• Product Type: Human Prescription Drug
• Proprietary Name: Butalbita,Acetaminophen and Caffeine
• Generic Name: Butalbita,acetaminophen And Caffeine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA213321
• Labeler Name: Granules Pharmaceuticals Inc.
• Substance Name: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70010-044-01

100 CAPSULE in 1 BOTTLE (70010-044-01)

• Marketing Start Date: 2020-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70010-044-01 [70010004401]

Butalbita,Acetaminophen and Caffeine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA213321
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-20

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 2407efce-b77e-4072-bc4b-62c789d01e1a
• Manufacturer:
  • Granules Pharmaceuticals Inc.
• UNII:
  • KHS0AZ4JVK
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 889520
• UPC Code:
  • 0370010044012

Pharmacological Class

• Barbiturates [CS]
• Barbiturate [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]