NDC 0591-3546

Butalbital, Aspirin, Caffeine and Codeine Phosphate

Butalbital, Aspirin, Caffeine And Codeine Phosphate

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

• Product ID: 0591-3546_53785743-ffd3-4044-94d8-341e581eb30b
• NDC: 0591-3546
• Product Type: Human Prescription Drug
• Proprietary Name: Butalbital, Aspirin, Caffeine and Codeine Phosphate
• Generic Name: Butalbital, Aspirin, Caffeine And Codeine Phosphate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2006-10-26
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA019429
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN
• Active Ingredient Strength: 30 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0591-3546-01

100 CAPSULE in 1 BOTTLE (0591-3546-01)

• Marketing Start Date: 2006-10-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3546-01 [00591354601]

Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA019429
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-26

NDC 0591-3546-05 [00591354605]

Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA019429
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-26

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	30 mg/1

OpenFDA Data

• SPL SET ID: ad135f46-5490-40e9-9add-1a953c6d6a9d
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • GSL05Y1MN6
  • KHS0AZ4JVK
  • R16CO5Y76E
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 994237
• 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:
  • 0305913546011
  • 0305913546059
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Barbiturates [CS]
• Barbiturate [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]
• 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]

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

NDC	Brand Name	Generic Name
0527-1312	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate
63629-2952	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE	Butalbital, Aspirin, Caffeine and Codeine Phosphate
69238-1993	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate
51991-074	Ascomp with Codeine	Butalbital, Aspirin, Caffeine and Codeine Phosphate