butalbital and acetaminophen
- Product NDC
- 0603-2540
- 11-digit product format
- 006032540
- Labeler code
- 0603
- Product ID
- 0603-2540_2d7cd016-87b7-12bf-e063-6294a90ac288
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo USA
- Application
- ANDA089987
- Marketing category
- ANDA
- Marketing start
- 1999-06-03
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 325; 50 mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS]
- 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 |
|---|
| 0603-2540-21 | butalbital and acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0603-2540 | BUTALBITAL AND ACETAMINOPHEN TABLET [ENDO USA] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250209_e619b656-4123-4878-b601-b0edad3c428b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0603-2540-21 | 00603254021 | 100 TABLET in 1 BOTTLE (0603-2540-21) | 100 tablet | 1999-06-03 | 0000-00-00 | No | No | Current |