NDC 0722-6094

Ascomp with Codeine

Butalbital, Aspirin, Cafeine, And Codeine Phosphate

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

• Product ID: 0722-6094_02774411-cc86-46a1-9bb7-2ac867f9c7ed
• NDC: 0722-6094
• Product Type: Human Prescription Drug
• Proprietary Name: Ascomp with Codeine
• Generic Name: Butalbital, Aspirin, Cafeine, And Codeine Phosphate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2001-11-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075231
• Labeler Name: Nexgen 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: 2021-12-31

Packaging

NDC 0722-6094-01

100 CAPSULE in 1 BOTTLE (0722-6094-01)

• Marketing Start Date: 2001-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0722-6094-05 [00722609405]

Ascomp with Codeine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-11-30

NDC 0722-6094-01 [00722609401]

Ascomp with Codeine CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-11-30

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: ca3fe6e9-21ad-4fba-a602-e1c364cf3981
• Manufacturer:
  • Nexgen Pharma, Inc.
• UNII:
  • KHS0AZ4JVK
  • GSL05Y1MN6
  • R16CO5Y76E
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 994239
  • 994237
• 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]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Ascomp with Codeine" or generic name "Butalbital, Aspirin, Cafeine, And Codeine Phosphate"

NDC	Brand Name	Generic Name
0722-6094	Ascomp with Codeine	Butalbital, Aspirin, Cafeine, and Codeine Phosphate
51991-074	Ascomp with Codeine	Butalbital, Aspirin, Caffeine and Codeine Phosphate
79739-6094	Ascomp with Codeine	Butalbital, Aspirin, Cafeine, and Codeine Phosphate