Butalbital, Aspirin, Caffeine, and Codeine Phosphate
- Product NDC
- 68308-312
- 11-digit product format
- 683080312
- Labeler code
- 68308
- Product ID
- 68308-312_5b8f52bb-642d-479b-9537-36f06776bf14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Aspirin, Caffeine, and Codeine Phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA203335
- Marketing category
- ANDA
- Marketing start
- 2015-10-30
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 50 mg/1; mg/1; mg/1; mg/1
- Pharmacologic 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
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68308-312-10 | 68308031210 | 100 CAPSULE in 1 BOTTLE (68308-312-10) | 100 capsule | 2015-10-30 | 0000-00-00 | No | No | Current |