BUTALBITAL and ACETAMINOPHEN
- Product NDC
- 70752-148
- 11-digit product format
- 707520148
- Labeler code
- 70752
- Product ID
- 70752-148_d113b27d-2b74-45ad-b095-d0cded8d4f6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUTALBITAL and ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QUAGEN PHARMACEUTICALS LLC
- Application
- ANDA214291
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 325; 50 mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [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 and ACETAMINOPHEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK |
| Rxcui | 197426 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70752-148-10 | BUTALBITAL and ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 70752-148-14 | BUTALBITAL and ACETAMINOPHEN | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70752-148 | BUTALBITAL AND ACETAMINOPHEN TABLET [QUAGEN PHARMACEUTICALS LLC] | 3 | Current NDC, 2 package rows | 20240508_2eb09253-7f59-401e-afbc-70bb9600fedf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70752-148-10 | 70752014810 | 100 TABLET in 1 BOTTLE (70752-148-10) | 100 tablet | 2024-05-01 | No | No | Current |
| 70752-148-14 | 70752014814 | 500 TABLET in 1 BOTTLE (70752-148-14) | 500 tablet | 2024-05-01 | No | No | Current |