Ascomp with Codeine
- Product NDC
- 79739-6094
- 11-digit product format
- 797396094
- Labeler code
- 79739
- Product ID
- 79739-6094_e8714e9d-80cc-4c5e-b469-67ce10256d85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Aspirin, Cafeine, and Codeine Phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- LGM PHARMA SOLUTIONS, LLC
- Application
- ANDA075231
- Marketing category
- ANDA
- Marketing start
- 2001-11-30
- Substance
- ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ascomp with Codeine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R16CO5Y76E, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6 |
| Rxcui | 994237, 994239 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79739-6094-1 | Ascomp with Codeine | 100 in 1 BOTTLE | CAPSULE | 100 | 15 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 79739-6094 | ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE) CAPSULE [LGM PHARMA SOLUTIONS, LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241018_1cab3106-1064-4b42-892b-39f405d9e02f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 994239 | Ascomp with Codeine 50 MG / 325 MG / 40 MG / 30 MG Oral Capsule | PSN | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994237 | butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | PSN | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994239 | aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [Ascomp] | SBD | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994237 | aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SCD | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994237 | ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SY | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994239 | ASA 325 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [Ascomp] | SY | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
| 994239 | Ascomp with Codeine (ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG) Oral Capsule | SY | 1cab3106-1064-4b42-892b-39f405d9e02f | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 79739-6094-1 | 79739609401 | 100 CAPSULE in 1 BOTTLE (79739-6094-1) | 100 capsule | 2020-07-24 | 0000-00-00 | No | No | Current |