Butalbital, Acetaminophen and Caffeine
- Product NDC
- 68788-9025
- 11-digit product format
- 687889025
- Labeler code
- 68788
- Product ID
- 68788-9025_3f1f716e-cb6b-4572-8e3d-3f59d201ef41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 68788-9025-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
| 68788-9025-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
| 68788-9025-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
| 68788-9025-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
| 68788-9025-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
| 68788-9025-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e46-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP R x Only Rev. 06/17 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9025-1 | Butalbital, Acetaminophen and Caffeine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
| 68788-9025-2 | Butalbital, Acetaminophen and Caffeine | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 8 |
| 68788-9025-3 | Butalbital, Acetaminophen and Caffeine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 8 |
| 68788-9025-6 | Butalbital, Acetaminophen and Caffeine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 8 |
| 68788-9025-8 | Butalbital, Acetaminophen and Caffeine | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 8 |
| 68788-9025-9 | Butalbital, Acetaminophen and Caffeine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 8 |
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.] | 5 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9025 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 8 | Legacy NDC, 6 package rows | 20180331_41fbd224-1239-4d89-8e19-0a300cd66f38.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68788-9025-1 | 68788902501 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 68788-9025-2 | 68788902502 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 68788-9025-3 | 68788902503 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68788-9025-6 | 68788902506 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68788-9025-8 | 68788902508 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 68788-9025-9 | 68788902509 | 90 in 1 BOTTLE, PLASTIC | Historical |