Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 70710-1378
- 11-digit product format
- 707101378
- Labeler code
- 70710
- Product ID
- 70710-1378_98db8c57-2704-4987-a635-4a6eb12c10ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA211543
- Marketing category
- ANDA
- Marketing start
- 2020-07-21
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1378-1 | Butalbital, Acetaminophen, and Caffeine | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 70710-1378-5 | Butalbital, Acetaminophen, and Caffeine | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1378 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ] | 4 | Legacy NDC, 2 package rows | 20211218_b56640f6-b7f5-4af1-96ba-41b2dd9a42be.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 |
|---|
| 70710-1378-1 | 70710137801 | 100 TABLET in 1 BOTTLE (70710-1378-1) | 100 tablet | 2020-07-21 | 0000-00-00 | No | No | Current |
| 70710-1378-5 | 70710137805 | 500 TABLET in 1 BOTTLE (70710-1378-5) | 500 tablet | 2020-07-21 | 0000-00-00 | No | No | Current |