Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 50436-3369
- 11-digit product format
- 504363369
- Labeler code
- 50436
- Product ID
- 50436-3369_7abeab39-c949-4231-a242-11e5ee6bc33f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA088616
- Marketing category
- ANDA
- Marketing start
- 2007-12-13
- 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
- 2020-12-31
- 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 |
|---|
| 50436-3369-1 | Butalbital, Acetaminophen, and Caffeine | 1 in 1 POUCH | TABLET | 1 | | 2 |
| 50436-3369-1 | Butalbital, Acetaminophen, and Caffeine | 50 in 1 BOX, UNIT-DOSE | TABLET | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-3369 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [UNIT DOSE SERVICES] | 2 | Legacy NDC, 2 package rows | 20180404_673648ec-81ea-4f9f-a988-19016683aa6d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-3369-1 | 50436336901 | 1 in 1 POUCH | Historical |