Application 210817
- Type
- ANDA
- Sponsor
- MAYNE PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | CAPSULE;ORAL | 300MG;50MG;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210817-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210817-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2019-12-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210817-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210817-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210817-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210817-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210817-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210817-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210817-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210817-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210817-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210817-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210817-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210817-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210817-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210817-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210817-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210817-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210817-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A210817-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210817-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210817-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210817-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A210817-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A210817-001 | AA | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210817-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210817-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210817-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210817-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210817-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210817-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210817-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210817-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210817-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210817-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A210817-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A210817-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210817-001 | AA | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210817-001 | AA | 1 | a50c72e98297… |
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 | Sun Pharmaceutical Industries, Inc. | a68de112-f5af-49ba-a8a8-3adbaa7df36e | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | f6bd2076-869e-40de-94ce-6be43d50f680 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 8a4cf981-37f7-4bc9-a9d7-b134a5fd0894 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Preferred Pharmaceuticals Inc. | 65fa9aca-ef3d-4bc6-a107-72e6eb5ce224 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | REMEDYREPACK INC. | 3c761587-3090-425e-bc83-139c32c9439d | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Amici Pharma, Inc. | fb12459c-82f8-43d2-8c05-a4b6d4a3e948 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | REMEDYREPACK INC. | 157fd0d2-aa54-406c-bcdb-dad531de3ce7 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Strides Pharma Science Limited | ac9e0cbf-aca6-4cb6-b63a-c25713c5200d | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Redpharm Drug | 4727e806-102a-3a28-e063-6294a90ab6e9 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| 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 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Chartwell RX, LLC | 77776146-c6e6-478c-b30e-2b729e758400 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Genus Lifesciences Inc. | 5f603b0d-69e5-4c02-b6b3-b4705e243e9a | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ST. MARY'S MEDICAL PARK PHARMACY | 36229f70-aa73-b112-e063-6394a90a5b49 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Aurolife Pharma, LLC | f9fde75d-7def-48fc-a2b0-727f677f6001 | 2025-04-14 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | A-S Medication Solutions | 21a148d1-b242-4414-82b2-cb78387d7d0f | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 03475828-eae2-49ed-a1c0-8074f35c712d | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Advanced Rx of Tennessee, LLC | 2e20e0ee-dd73-6287-e063-6294a90a03b1 | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | SUNRISE PHARMACEUTICAL, INC | ee7630f8-f4b8-4eb0-b34d-d908567030c4 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-542 | butalbital, acetaminophen and caffeine | butalbital, acetaminophen and caffeine | Mayne Pharma | ANDA | Current |
| 51862-542 | butalbital, acetaminophen and caffeine | butalbital, acetaminophen and caffeine | Mayne Pharma | ANDA | Current |