Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Product NDC
- 79739-7028
- 11-digit product format
- 797397028
- Labeler code
- 79739
- Product ID
- 79739-7028_54ce8291-ad32-4dd5-b372-52db3029d951
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- LGM Pharma Solutions, LLC
- Application
- ANDA076560
- Marketing category
- ANDA
- Marketing start
- 2004-06-10
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 79739-7028-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53dd-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992 |
| 79739-7028-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53dd-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79739-7028-1 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 2 |
| 79739-7028-5 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79739-7028 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [LGM PHARMA SOLUTIONS, LLC] | 2 | Legacy NDC, 2 package rows | 20210615_b96c0356-39e3-496a-a622-603f8a91f49e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 79739-7028-1 | 79739702801 | 100 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-1) | 100 capsule | 2004-06-10 | 0000-00-00 | No | No | Current |
| 79739-7028-5 | 79739702805 | 500 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-5) | 500 capsule | 2004-06-10 | 0000-00-00 | No | No | Current |