butalbital and acetaminophen
- Product NDC
- 70010-054
- 11-digit product format
- 700100054
- Labeler code
- 70010
- Product ID
- 70010-054_f4a2f8f9-7dc7-395b-e053-2995a90a6f00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA213115
- Marketing category
- ANDA
- Marketing start
- 2020-01-20
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 300; 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 | 300 mg/1 |
| BUTALBITAL | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK |
| Rxcui | 1995136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-054-01 | butalbital and acetaminophen | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 70010-054-05 | butalbital and acetaminophen | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-054 | BUTALBITAL AND ACETAMINOPHEN CAPSULE [GRANULES PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230215_2091c292-b77b-4ce6-8bba-436c74eee3d7.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 |
|---|
| 70010-054-01 | 70010005401 | 100 CAPSULE in 1 BOTTLE (70010-054-01) | 100 capsule | 2020-01-20 | 0000-00-00 | No | No | Current |
| 70010-054-05 | 70010005405 | 500 CAPSULE in 1 BOTTLE (70010-054-05) | 500 capsule | 2020-01-20 | 0000-00-00 | No | No | Current |