BUTALBITAL AND ACETAMINOPHEN
- Product NDC
- 69292-301
- 11-digit product format
- 692920301
- Labeler code
- 69292
- Product ID
- 69292-301_176a055a-162d-4f4e-a44e-8355ee4a98fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma, Inc.
- Application
- ANDA214088
- Marketing category
- ANDA
- Marketing start
- 2026-03-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUTALBITAL AND ACETAMINOPHEN
- Listing expiration
- 2027-12-31
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 | 197426, 1249617, 1724446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69292-301-01 | BUTALBITAL AND ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69292-301-01 | 69292030101 | 100 TABLET in 1 BOTTLE (69292-301-01) | 100 tablet | 2026-03-15 | No | No | Current |