Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 68788-6939
- 11-digit product format
- 687886939
- Labeler code
- 68788
- Product ID
- 68788-6939_94e2b4db-1514-4b66-ae2e-8374e3afc586
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA200243
- Marketing category
- ANDA
- Marketing start
- 2017-03-29
- 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 |
|---|
| 68788-6939-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 68788-6939-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 68788-6939-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 68788-6939-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 68788-6939-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 68788-6939-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-00d8-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 |
|---|
| 68788-6939-1 | Butalbital, Acetaminophen, and Caffeine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 2 |
| 68788-6939-2 | Butalbital, Acetaminophen, and Caffeine | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 2 |
| 68788-6939-3 | Butalbital, Acetaminophen, and Caffeine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 68788-6939-6 | Butalbital, Acetaminophen, and Caffeine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 2 |
| 68788-6939-8 | Butalbital, Acetaminophen, and Caffeine | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 2 |
| 68788-6939-9 | Butalbital, Acetaminophen, and Caffeine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-6939 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] | 2 | Legacy NDC, 6 package rows | 20180403_85ce51e7-18c5-4ef2-8084-b1629dc32263.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68788-6939-1 | 68788693901 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 68788-6939-2 | 68788693902 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 68788-6939-3 | 68788693903 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68788-6939-6 | 68788693906 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68788-6939-8 | 68788693908 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 68788-6939-9 | 68788693909 | 90 in 1 BOTTLE, PLASTIC | Historical |