Butalbital, Acetaminophen and Caffeine
- Product NDC
- 0603-2544
- 11-digit product format
- 006032544
- Labeler code
- 0603
- Product ID
- 0603-2544_8bb6c272-2bf7-428b-a766-0b172d65f224
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA040511
- Marketing category
- ANDA
- Marketing start
- 2003-08-27
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Active strength
- 325 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0603-2544-21 | 2022-09-23 | C162847 | 48780-1 | e4f33bdf-a2c4-d8a0-e053-dadaa90a6e4e | aedc5167-cc3c-4044-87fa-4ed648c9f23f |
| 0603-2544-28 | 2022-09-23 | C162847 | 48780-1 | e4f33bdf-a2c4-d8a0-e053-dadaa90a6e4e | aedc5167-cc3c-4044-87fa-4ed648c9f23f |
| 0603-2544-21 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a2c4-d8a0-e053-dadaa90a6e4e | aedc5167-cc3c-4044-87fa-4ed648c9f23f |
| 0603-2544-28 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a2c4-d8a0-e053-dadaa90a6e4e | aedc5167-cc3c-4044-87fa-4ed648c9f23f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-2544-02 | EA - Each | 0603-2544 | 6d3940e5-405c-4617-b515-3bc08e7821b4 | 1 | 2012-07-24 |
| 0603-2544-20 | EA - Each | 0603-2544 | 7c5a16d6-e74a-4c10-b412-e83cbcd553bb | 1 | 2012-07-24 |
| 0603-2544-21 | EA - Each | 0603-2544 | f19c6430-f6dd-454f-8922-08d791f0c2d9 | 1 | 2012-07-24 |
| 0603-2544-28 | EA - Each | 0603-2544 | 104552f5-81aa-4314-bbff-8fc084c1ff51 | 1 | 2012-07-24 |
| 0603-2544-32 | EA - Each | 0603-2544 | 22eab70a-0a83-42ee-ad07-d498e25639ab | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 97c50a3b-f954-46ed-9fa5-b9a45d485f1d | 6 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 97c50a3b-f954-46ed-9fa5-b9a45d485f1d | 6 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 97c50a3b-f954-46ed-9fa5-b9a45d485f1d | 6 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 1434df11-6e37-4722-a4c0-972e5c5899f8 | 1 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | e8982243-5634-400a-8b23-8029fb4e5e92 | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 1434df11-6e37-4722-a4c0-972e5c5899f8 | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | e8982243-5634-400a-8b23-8029fb4e5e92 | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 1434df11-6e37-4722-a4c0-972e5c5899f8 | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | e8982243-5634-400a-8b23-8029fb4e5e92 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0603-2544-21 | 00603254421 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-2544-21) | 100 tablet | 2003-08-27 | 0000-00-00 | No | No | Current |
| 0603-2544-28 | 00603254428 | 500 TABLET in 1 BOTTLE, PLASTIC (0603-2544-28) | 500 tablet | 2003-08-27 | 0000-00-00 | No | No | Current |