NDC 0591-3219

Butalbital, Aspirin, and Caffeine

Butalbital, Aspirin, And Caffeine

Butalbital, Aspirin, and Caffeine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Butalbital; Aspirin; Caffeine.

• Product ID: 0591-3219_2e5315af-f5b8-4eb1-b019-5cfcd71d9820
• NDC: 0591-3219
• Product Type: Human Prescription Drug
• Proprietary Name: Butalbital, Aspirin, and Caffeine
• Generic Name: Butalbital, Aspirin, And Caffeine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2003-10-06
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA017534
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: BUTALBITAL; ASPIRIN; CAFFEINE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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: 2022-12-31

Packaging

NDC 0591-3219-01

100 CAPSULE in 1 BOTTLE (0591-3219-01)

• Marketing Start Date: 2003-10-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3219-01 [00591321901]

Butalbital, Aspirin, and Caffeine CAPSULE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA017534
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-10-06

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: e31096f4-162f-44bd-a211-9c2873acfe54
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • KHS0AZ4JVK
  • R16CO5Y76E
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 238134
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• UPC Code:
  • 0305913219014
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

Pharmacological Class

• Barbiturates [CS]
• Barbiturate [EPC]
• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Platelet Aggregation Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Butalbital, Aspirin, and Caffeine" or generic name "Butalbital, Aspirin, And Caffeine"

NDC	Brand Name	Generic Name
0527-1552	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine
0591-3219	Butalbital, Aspirin, and Caffeine	butalbital, aspirin, and caffeine
21695-139	Butalbital, Aspirin, and Caffeine	butalbital, aspirin, and caffeine
29033-215	Butalbital, Aspirin, and Caffeine	Butalbital, Aspirin, and Caffeine
33261-922	Butalbital, Aspirin, and Caffeine	butalbital, aspirin, and caffeine
50090-1580	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine
55700-129	Butalbital, aspirin, and caffeine	Butalbital, aspirin, and caffeine
62135-433	butalbital, aspirin, and caffeine	butalbital, aspirin, and caffeine
79739-7192	Butalbital, Aspirin, and Caffeine	Butalbital, Aspirin, and Caffeine
0023-6146	Fiorinal	Butalbital, Aspirin, and Caffeine
52544-955	Fiorinal	Butalbital, Aspirin, and Caffeine