Butalbital And Acetaminophen
- Product NDC
- 68047-721
- 11-digit product format
- 680470721
- Labeler code
- 68047
- Product ID
- 68047-721_41348343-4fef-7234-e063-6394a90af41d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Larken Laboratories, Inc.
- Application
- ANDA203484
- Marketing category
- ANDA
- Marketing start
- 2015-12-04
- 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, 1724446, 2279007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68047-721-01 | Butalbital And Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 68047-721-30 | Butalbital And Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68047-721 | BUTALBITAL AND ACETAMINOPHEN TABLET BUTALBITAL AND ACETAMINOPHEN TABLET ALLZITAL (BUTALBITAL AND ACETAMINOPHEN) TABLET [LARKEN LABORATORIES, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241012_326c83fc-afed-45ad-9c87-f47968fa1d2a.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 |
|---|
| 68047-721-01 | 68047072101 | 100 TABLET in 1 BOTTLE (68047-721-01) | 100 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |
| 68047-721-30 | 68047072130 | 30 TABLET in 1 BOTTLE (68047-721-30) | 30 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |