BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Product NDC
- 13925-535
- Requested package NDC
- 13925-535-01
- 11-digit product format
- 139250535
- Labeler code
- 13925
- Product ID
- 13925-535_5b7dfab1-0311-4748-9dc0-9e7e33c3eac4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, acetaminophen and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Seton Pharmaceuticals LLC
- Application
- ANDA214087
- Marketing category
- ANDA
- Marketing start
- 2022-03-02
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | |
| A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214087-001 | AA |
| A214087-002 | 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 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214087-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 300MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214087-002 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | CAPSULE / ORAL | AA | 2021-08-13 | 6a51e52b5d6a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A214087-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214087-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214087-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214087-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214087-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214087-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214087-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214087-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214087-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214087-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214087-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214087-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214087-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214087-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214087-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214087-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214087-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214087-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214087-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214087-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214087-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214087-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214087-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214087-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214087-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214087-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214087-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A214087-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214087-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214087-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A214087-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A214087-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214087-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A214087-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A214087-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A214087-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A214087-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A214087-002 | AA | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214087-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214087-002 | AA | 1 | 6a51e52b5d6a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Listing expiration
- 2026-12-31
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 |
| 3G6A5W338E | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3c5cefe3-c84e-4380-97f3-78e3fe92543a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13925-535-01 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 100 in 1 BOTTLE | CAPSULE | 100 | 3 |
DailyMed Dashboard NDC Coverage#
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 | Amici Pharma, Inc. | fb12459c-82f8-43d2-8c05-a4b6d4a3e948 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 214087 ANDA214087 |
| 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 | 214087 ANDA214087 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | SOLCO HEALTHCARE US, LLC | 5c9c3407-212a-4ae9-a574-2b0c53f3c5eb | 2024-09-10 | Boxed warning, Warnings, Adverse reactions | 214087 ANDA214087 |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Seton Pharmaceuticals LLC | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 214087 ANDA214087 13925-535-01 13925-535 13925053501 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 889520 | butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule | PSN | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
| 238153 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Capsule | PSN | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
| 889520 | acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule | SCD | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
| 238153 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule | SCD | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
| 889520 | APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule | SY | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
| 238153 | APAP 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule | SY | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 13925-535-01 | 13925053501 | 100 CAPSULE in 1 BOTTLE (13925-535-01) | 100 capsule | 2022-03-02 | 0000-00-00 | No | No | Current |