Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 0591-3369
- Requested package NDC
- 0591-3369-01
- 11-digit product format
- 005913369
- Labeler code
- 0591
- Product ID
- 0591-3369_44b619cd-6f35-43c0-893b-9d72c049fed4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA088616
- Marketing category
- ANDA
- Marketing start
- 2007-12-13
- 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]
- 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 |
|---|---|---|---|---|---|---|---|
| A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088616-001 | 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 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088616-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A088616-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088616-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088616-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088616-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088616-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088616-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088616-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088616-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088616-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088616-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088616-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088616-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088616-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088616-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088616-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088616-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088616-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088616-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088616-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088616-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088616-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088616-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088616-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088616-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088616-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088616-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088616-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088616-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088616-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088616-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088616-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088616-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088616-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088616-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088616-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088616-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088616-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088616-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088616-001 | AA | 1 | f41ea6bd6efb… |
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 |
|---|---|
| a6cbc17f-5c60-489c-8029-84b0add556d8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-3369-01 | Butalbital, Acetaminophen, and Caffeine | 100 in 1 BOTTLE | TABLET | 100 | 17 | |
| 0591-3369-05 | Butalbital, Acetaminophen, and Caffeine | 500 in 1 BOTTLE | TABLET | 500 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3369-01 | EA - Each | 0591-3369 | f9f4172c-decd-40ed-acbe-c081dc5f5be4 | 1 | 2012-07-24 |
| 0591-3369-05 | EA - Each | 0591-3369 | c7c0d508-3196-4bf7-b2d9-170d30fb9d3d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | a6cbc17f-5c60-489c-8029-84b0add556d8 | 17 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | a6cbc17f-5c60-489c-8029-84b0add556d8 | 17 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | a6cbc17f-5c60-489c-8029-84b0add556d8 | 17 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 9a9fe1f1-eafd-44c9-923b-bea787b5e7e0 | 7 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 9a9fe1f1-eafd-44c9-923b-bea787b5e7e0 | 7 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 9a9fe1f1-eafd-44c9-923b-bea787b5e7e0 | 7 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | d134544e-e54c-41fd-8c89-d7f017fb0829 | 4 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | d134544e-e54c-41fd-8c89-d7f017fb0829 | 4 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | d134544e-e54c-41fd-8c89-d7f017fb0829 | 4 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 673648ec-81ea-4f9f-a988-19016683aa6d | 2 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 673648ec-81ea-4f9f-a988-19016683aa6d | 2 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 673648ec-81ea-4f9f-a988-19016683aa6d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-3369-01 | 00591336901 | 100 TABLET in 1 BOTTLE (0591-3369-01) | 100 tablet | 2007-12-13 | 0000-00-00 | No | No | Current |