BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Product NDC
- 72162-2666
- Requested package NDC
- 72162-2666-5
- 11-digit product format
- 721622666
- Labeler code
- 72162
- Product ID
- 72162-2666_2a698b10-73ef-4db0-b1df-7dd9089e710e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA214287
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50; 325; 40 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]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214287-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | 1c564ffb4f44… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214287-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2024-01-18 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214287-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214287-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214287-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214287-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214287-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214287-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214287-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214287-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214287-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214287-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214287-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214287-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214287-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214287-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214287-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214287-001 | AA | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214287-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A214287-001 | AA | 1 | 1c564ffb4f44… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214287-001 | AA | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUTALBITAL | 50 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
| CAFFEINE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| KHS0AZ4JVK | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 3G6A5W338E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 238154 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f6bd2076-869e-40de-94ce-6be43d50f680 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | f6bd2076-869e-40de-94ce-6be43d50f680 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 72162-2666-5 72162-2666 72162266605 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Advanced Rx of Tennessee, LLC | 45a18fad-ad4e-3a1b-e063-6394a90a23cf | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Preferred Pharmaceuticals Inc. | 91e50642-d278-47c6-944b-4ed907e87e6b | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 24813ec6-0111-4782-9182-a2b93501a2bc | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 214287 ANDA214287 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72162-2666-5 | 72162266605 | 500 TABLET in 1 BOTTLE, PLASTIC (72162-2666-5) | 500 tablet | 2026-07-13 | No | No | Current |