NDC 68308-312

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 Mayne Pharma Inc.. The primary component is Butalbital; Aspirin; Caffeine; Codeine Phosphate.

• Product ID: 68308-312_32e499ea-9f5f-44ad-97cc-7ca708c76135
• NDC: 68308-312
• 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: 2015-10-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203335
• Labeler Name: Mayne Pharma Inc.
• Substance Name: BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
• Active Ingredient Strength: 50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68308-312-10

100 CAPSULE in 1 BOTTLE (68308-312-10)

• Marketing Start Date: 2015-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68308-312-10 [68308031210]

Butalbital, Aspirin, Caffeine, and Codeine Phosphate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA203335
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-30

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 3dd63865-af88-4cfe-a028-a21b3e65c25d
• Manufacturer:
  • Mayne Pharma Inc.
• UNII:
  • KHS0AZ4JVK
  • GSL05Y1MN6
  • 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:
  • 0368308312103
• 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]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• 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]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Medicade Reported Pricing

68308031210 ASA-BUTALB-CAFF-COD #3 CAPSULE

Pricing Unit: EA | Drug Type:

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
68308-312	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Butalbital, Aspirin, Caffeine, and Codeine Phosphate
51991-074	Ascomp with Codeine	BUTALBITAL, ASPIRIN, CAFFEINE, and CODEINE PHOSPHATE
0023-6010	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate
52544-956	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate