butalbital, acetaminophen and caffeine
- Product NDC
- 68788-9711
- 11-digit product format
- 687889711
- Labeler code
- 68788
- Product ID
- 68788-9711_3bb4595e-fbff-412b-b94f-0feeaf4d5b39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, acetaminophen and caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA089175
- Marketing category
- ANDA
- Marketing start
- 2013-01-30
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 68788-9711-1 | butalbital, acetaminophen and caffeine | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68788-9711-2 | butalbital, acetaminophen and caffeine | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 68788-9711-3 | butalbital, acetaminophen and caffeine | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68788-9711-6 | butalbital, acetaminophen and caffeine | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68788-9711-8 | butalbital, acetaminophen and caffeine | 120 in 1 BOTTLE | TABLET | 120 | | 5 |
| 68788-9711-9 | butalbital, acetaminophen and caffeine | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9711 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 6 package rows | 20180331_71ab0446-3772-4680-93c5-8020d21dc15f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68788-9711-1 | 68788971101 | 100 in 1 BOTTLE | Historical |
| 68788-9711-2 | 68788971102 | 20 in 1 BOTTLE | Historical |
| 68788-9711-3 | 68788971103 | 30 in 1 BOTTLE | Historical |
| 68788-9711-6 | 68788971106 | 60 in 1 BOTTLE | Historical |
| 68788-9711-8 | 68788971108 | 120 in 1 BOTTLE | Historical |
| 68788-9711-9 | 68788971109 | 90 in 1 BOTTLE | Historical |