Butalbital, Acetaminophen and Caffeine
- Product NDC
- 0904-6538
- 11-digit product format
- 009046538
- Labeler code
- 0904
- Product ID
- 0904-6538_ca7cabf0-f30b-422d-af41-b2ffd6ae0e8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-6538-06 | 2023-01-18 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-40 | 2023-01-18 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-60 | 2023-01-18 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-80 | 2023-01-18 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-06 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-40 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
| 0904-6538-80 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1719-a910-e053-dadaa90a0b85 | 19b523f6-6cfb-44a8-83d1-8bac5f7d6045 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6538-06 | EA - Each | 0904-6538 | 287ce88d-67b1-425b-9385-7a18f252cbaa | 1 | 2017-10-13 |
| 0904-6538-40 | EA - Each | 0904-6538 | 1615d69b-78f0-4a5c-b55e-aa8b989318d1 | 1 | 2016-03-04 |
| 0904-6538-60 | EA - Each | 0904-6538 | 3b4efc5f-83ca-4fd6-afae-c050d079bf58 | 1 | 2016-03-04 |
| 0904-6538-80 | EA - Each | 0904-6538 | a2b572d7-e0a2-4b11-a492-a4b78da1c76e | 1 | 2016-03-04 |