NDC 42543-098

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 Vensun Pharmaceuticals, Inc.. The primary component is Butalbital; Aspirin; Caffeine.

• Product ID: 42543-098_192e71b5-d399-4698-88bf-534ff69d7393
• NDC: 42543-098
• 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: 2017-06-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204195
• Labeler Name: Vensun Pharmaceuticals, 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: 2020-12-31

Packaging

NDC 42543-098-01

100 TABLET in 1 BOTTLE, PLASTIC (42543-098-01)

• Marketing Start Date: 2017-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42543-098-01 [42543009801]

Butalbital, Aspirin and Caffeine TABLET

• Marketing Category: ANDA
• Application Number: ANDA204195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: ce47777f-8cf7-4f53-b48f-165b83516896
• Manufacturer:
  • Vensun Pharmaceuticals, Inc.
• 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]
• UPC Code:
  • 0342543098015
• 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]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• 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]

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