Application 209587
- Type
- ANDA
- Sponsor
- NEXGEN PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | TABLET;ORAL | 325MG;50MG;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209587-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209587-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209587-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209587-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209587-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209587-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209587-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209587-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209587-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209587-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209587-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209587-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209587-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209587-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209587-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209587-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209587-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209587-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209587-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209587-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209587-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209587-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209587-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209587-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209587-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209587-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209587-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209587-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209587-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209587-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209587-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209587-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209587-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209587-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209587-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209587-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209587-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209587-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209587-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209587-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A209587-001 | AA | 1 | e64feba35796… |
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, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | HAWAII REPACK, INC. | ab882f60-394c-4d4f-95f4-6b9d6d6b3193 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Preferred Pharmaceuticals Inc. | b121190e-db2a-43bb-a57d-b6683a9e2059 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 68788-8137 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Advanced Rx of Tennessee, LLC | 4871c36f-229b-4c12-e063-6394a90a028e | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | REMEDYREPACK INC. | dc2bb7fc-1722-4865-a02c-be5e5c211505 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Asclemed USA, Inc. | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| BUTAL/APAP/CAFFEINE | BUTAL/APAP/CAFFEINE | Direct_Rx | 2abb9915-edb2-6218-e063-6394a90ad462 | 2025-05-08 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | AvPAK | e5fbd6b8-85e7-8847-e053-2a95a90a52ed | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 50268-553 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Proficient Rx LP | 3cf799b4-c785-4ae2-908b-c42e426733dc | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 71205-510 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Bryant Ranch Prepack | e2978345-826a-47d2-acf3-feb6afb1967e | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 71335-1764 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | LGM PHARMA SOLUTIONS, LLC | f6548126-faa1-4f53-8e0b-bc1b743de04d | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 79739-7320 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | A-S Medication Solutions | f822c103-b678-4e76-8174-33b94421dd1e | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Proficient Rx LP | d860af16-fab4-4263-9e66-a648d5e81dab | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 71205-981 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Bryant Ranch Prepack | 90e166ac-8789-4e7a-b5bb-37c475e3a5b0 | 2023-06-08 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 71335-1767 |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Westminster Pharmaceuticals, LLC | 1c0511d0-fe63-45c6-8da2-6ceeb56edb17 | 2019-03-01 | Boxed warning, Warnings, Adverse reactions | 209587 ANDA209587 69367-203 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0722-7320 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Nexgen Pharma, Inc. | ANDA | Current |
| 0722-7320 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Nexgen Pharma, Inc. | ANDA | Current |
| 0722-7320 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Nexgen Pharma, Inc. | ANDA | Current |
| 50268-553 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | AvPAK | ANDA | Current |
| 50268-553 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | AvPAK | ANDA | Current |
| 53002-6031 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-920 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Quality Care Products, LLC | ANDA | Current |
| 55700-920 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Quality Care Products, LLC | ANDA | Current |
| 68071-2365 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2365 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2365 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7882 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8137 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69367-203 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-203 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-203 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 70518-2995 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2995 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 71205-510 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 71205-510 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 71205-981 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 71205-981 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 71205-981 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 71335-1764 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1764 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1767 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1767 | Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 79739-7320 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | LGM Pharma Solutions, LLC | ANDA | Current |