Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 21695-209
- 11-digit product format
- 216950209
- Labeler code
- 21695
- Product ID
- 21695-209_fef4844c-2b44-4e5c-9da3-e5b2214c9e8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA089718
- Marketing category
- ANDA
- Marketing start
- 1995-06-12
- 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]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 21695-209-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4977-48b1-e053-8cdaa90a720a | Butalbital, Acetaminophen, and Caffeine Tablets, USP |
| 21695-209-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4977-48b1-e053-8cdaa90a720a | Butalbital, Acetaminophen, and Caffeine Tablets, USP |
| 21695-209-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4977-48b1-e053-8cdaa90a720a | Butalbital, Acetaminophen, and Caffeine Tablets, USP |
| 21695-209-72 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4977-48b1-e053-8cdaa90a720a | Butalbital, Acetaminophen, and Caffeine Tablets, USP |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Butalbital | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Caffeine | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Butalbital | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Caffeine | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Colloidal Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |