NDC 21695-354

Butalbital, Aspirin and Caffeine

Butalbital, Aspirin And Caffeine

Butalbital, Aspirin and Caffeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Butalbital; Aspirin; Caffeine.

• Product ID: 21695-354_4e10129b-41a3-4572-9564-6f8366b627dc
• NDC: 21695-354
• Product Type: Human Prescription Drug
• Proprietary Name: Butalbital, Aspirin and Caffeine
• Generic Name: Butalbital, Aspirin And Caffeine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-12-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086162
• Labeler Name: Rebel Distributors Corp
• Substance Name: BUTALBITAL; ASPIRIN; CAFFEINE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: 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]
• DEA Schedule: CIII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-354-60

60 TABLET in 1 BOTTLE (21695-354-60)

• Marketing Start Date: 2009-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-354-60 [21695035460]

Butalbital, Aspirin and Caffeine TABLET

• Marketing Category: ANDA
• Application Number: ANDA086162
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-15
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 4e10129b-41a3-4572-9564-6f8366b627dc
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • KHS0AZ4JVK
  • R16CO5Y76E
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 238135
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• 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
0143-1785	Butalbital, Aspirin and Caffeine	Butalbital, Aspirin and Caffeine
21695-354	Butalbital, Aspirin and Caffeine	Butalbital, Aspirin and Caffeine
42543-098	Butalbital, Aspirin and Caffeine	Butalbital, Aspirin and Caffeine
52959-370	Butalbital, Aspirin and Caffeine	Butalbital, Aspirin and Caffeine
66336-619	Butalbital, Aspirin and Caffeine	Butalbital, Aspirin and Caffeine