BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Product NDC
- 70752-142
- 11-digit product format
- 707520142
- Labeler code
- 70752
- Product ID
- 70752-142_33f4fcf9-9767-4d27-bae3-9c0698f568e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QUAGEN PHARMACEUTICALS LLC
- Application
- ANDA214287
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Active strength
- 325; 50; 40 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E |
| Rxcui | 238154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70752-142-10 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 3 | |
| 70752-142-14 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70752-142-10 | EA - Each | 70752-142 | d4bef786-01bb-4bbb-8168-ac3fbb8ec1e3 | 1 | 2024-05-16 |
| 70752-142-14 | EA - Each | 70752-142 | 98853646-2367-4ea0-91da-ee43ff5b1c8e | 1 | 2024-05-16 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 3c761587-3090-425e-bc83-139c32c9439d | 4 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 3c761587-3090-425e-bc83-139c32c9439d | 4 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 3c761587-3090-425e-bc83-139c32c9439d | 4 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 24813ec6-0111-4782-9182-a2b93501a2bc | 3 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 24813ec6-0111-4782-9182-a2b93501a2bc | 3 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 24813ec6-0111-4782-9182-a2b93501a2bc | 3 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 1 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 1 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 91e50642-d278-47c6-944b-4ed907e87e6b | 1 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 45a18fad-ad4e-3a1b-e063-6394a90a23cf | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 91e50642-d278-47c6-944b-4ed907e87e6b | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 45a18fad-ad4e-3a1b-e063-6394a90a23cf | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 45a18fad-ad4e-3a1b-e063-6394a90a23cf | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 91e50642-d278-47c6-944b-4ed907e87e6b | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70752-142-10 | 70752014210 | 100 TABLET in 1 BOTTLE, PLASTIC (70752-142-10) | 100 tablet | 2024-05-01 | No | No | Current |
| 70752-142-14 | 70752014214 | 500 TABLET in 1 BOTTLE, PLASTIC (70752-142-14) | 500 tablet | 2024-05-01 | No | No | Current |