Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 0722-7320
- 11-digit product format
- 007227320
- Labeler code
- 0722
- Product ID
- 0722-7320_3fc83e77-4fb0-4374-b7b0-19af4baa1a43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nexgen Pharma, Inc.
- Application
- ANDA209587
- Marketing category
- ANDA
- Marketing start
- 2018-11-01
- 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 |
|---|
| 0722-7320-01 | Butalbital, Acetaminophen, and Caffeine | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 0722-7320-05 | Butalbital, Acetaminophen, and Caffeine | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0722-7320 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [NEXGEN PHARMA, INC.] | 5 | Legacy NDC, 2 package rows | 20190910_da9e77e3-9f64-402a-83ac-eb0dc3cd1abe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0722-7320-01 | 00722732001 | 100 in 1 BOTTLE | Historical |
| 0722-7320-05 | 00722732005 | 500 in 1 BOTTLE | Historical |