Butalbital, Acetaminophen and Caffeine
- Product NDC
- 67544-394
- 11-digit product format
- 675440394
- Labeler code
- 67544
- Product ID
- 67544-394_68d8e3a9-cabb-46aa-b327-9d024d41a6e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040511
- Marketing category
- ANDA
- Marketing start
- 2003-08-27
- 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 |
|---|
| 67544-394-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4fcf-f424-e053-dadaa90a57ce | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg |
| 67544-394-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4fcf-f424-e053-dadaa90a57ce | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg |
| 67544-394-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4fcf-f424-e053-dadaa90a57ce | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg |
| 67544-394-70 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4fcf-f424-e053-dadaa90a57ce | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-394-30 | Butalbital, Acetaminophen and Caffeine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 67544-394-53 | Butalbital, Acetaminophen and Caffeine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 67544-394-60 | Butalbital, Acetaminophen and Caffeine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
| 67544-394-70 | Butalbital, Acetaminophen and Caffeine | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-394 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 4 package rows | 20140603_1434df11-6e37-4722-a4c0-972e5c5899f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67544-394-30 | 67544039430 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 67544-394-53 | 67544039453 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 67544-394-60 | 67544039460 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 67544-394-70 | 67544039470 | 120 in 1 BOTTLE, PLASTIC | Historical |