Butalbital, Acetaminophen and Caffeine
- Product NDC
- 51672-4222
- 11-digit product format
- 516724222
- Labeler code
- 51672
- Product ID
- 51672-4222_2035de72-f010-bc60-e063-6394a90a24f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, acetaminophen, and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA213046
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Active strength
- 300; 50; 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
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 51672-4222-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 51672-4222-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 51672-4222-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 51672-4222-1 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213046-001 | 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 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213046-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2020-07-01 | 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 | A213046-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213046-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213046-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213046-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213046-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213046-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213046-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213046-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213046-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213046-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213046-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213046-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213046-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213046-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213046-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213046-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213046-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213046-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213046-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213046-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A213046-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A213046-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A213046-001 | AA | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213046-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213046-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213046-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213046-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213046-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213046-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213046-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213046-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A213046-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213046-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213046-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A213046-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213046-001 | AA | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213046-001 | AA | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Butalbital, Acetaminophen and Caffeine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUTALBITAL | 300 mg/1 |
| ACETAMINOPHEN | 50 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 |
|---|---|
| 889520 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a68de112-f5af-49ba-a8a8-3adbaa7df36e | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-4222-1 | Butalbital, Acetaminophen and Caffeine | 100 in 1 BOTTLE | CAPSULE | 100 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4222-1 | EA - Each | 51672-4222 | 46e766c9-17e1-4a9d-b44b-03171e39ee6e | 1 | 2020-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-4222 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240823_a68de112-f5af-49ba-a8a8-3adbaa7df36e.zip |
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 | 213046 ANDA213046 51672-4222 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 889520 | butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule | PSN | a68de112-f5af-49ba-a8a8-3adbaa7df36e | 4 |
| 889520 | acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule | SCD | a68de112-f5af-49ba-a8a8-3adbaa7df36e | 4 |
| 889520 | APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule | SY | a68de112-f5af-49ba-a8a8-3adbaa7df36e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-4222-1 | 51672422201 | 100 CAPSULE in 1 BOTTLE (51672-4222-1) | 100 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |