Ascomp with Codeine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Butalbital; Aspirin; Caffeine; Codeine Phosphate.
| Product ID | 51991-074_1e56ab58-12bf-4fab-b7d3-5831c470cafd |
| NDC | 51991-074 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ascomp with Codeine |
| Generic Name | Butalbital, Aspirin, Caffeine And Codeine Phosphate |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-05-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075231 |
| Labeler Name | Breckenridge Pharmaceutical, 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 |
| Marketing Start Date | 2009-05-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075231 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-05-01 |
| Marketing Category | ANDA |
| Application Number | ANDA075231 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-05-01 |
| Ingredient | Strength |
|---|---|
| BUTALBITAL | 50 mg/1 |
| SPL SET ID: | 243a6aea-0f48-42a9-a85e-ff247ab94336 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| Pharm Class PE | |
| PHarm Class EPC | |
| UPC Code | |
| NUI Code |
| 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 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ASCOMP WITH CODEINE 78225703 3179162 Live/Registered |
NEXGEN PHARMA, INC. 2003-03-14 |