Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Product NDC
- 71335-0653
- Requested package NDC
- 71335-0653-4
- 11-digit product format
- 713350653
- Labeler code
- 71335
- Product ID
- 71335-0653_a29db87b-3f50-40ca-a5ab-406028ff19f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075929
- Marketing category
- ANDA
- Marketing start
- 2002-04-22
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 50 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71335-0653 | 71335-0653-4 | D | Discontinued by firm | 2026-10-05 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71335-0653 | 71335-0653-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71335-0653 | 71335-0653-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 |
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 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | 2002-04-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075929-001 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE / ORAL | AB | 2002-04-22 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A075929-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075929-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075929-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075929-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075929-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075929-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075929-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075929-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075929-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075929-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075929-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075929-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075929-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075929-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075929-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075929-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075929-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075929-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075929-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075929-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075929-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075929-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075929-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075929-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075929-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A075929-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075929-001 | AB | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-0653-1 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 20 in 1 BOTTLE | CAPSULE | 20 | 4 | |
| 71335-0653-2 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 90 in 1 BOTTLE | CAPSULE | 90 | 4 | |
| 71335-0653-3 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 30 in 1 BOTTLE | CAPSULE | 30 | 4 | |
| 71335-0653-4 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 60 in 1 BOTTLE | CAPSULE | 60 | 4 | |
| 71335-0653-5 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 100 in 1 BOTTLE | CAPSULE | 100 | 4 | |
| 71335-0653-6 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 15 in 1 BOTTLE | CAPSULE | 15 | 4 | |
| 71335-0653-7 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 18 in 1 BOTTLE | CAPSULE | 18 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0653 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK] | 4 | Legacy NDC, 7 package rows | 20200924_00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993943 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | PSN | 00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe | 4 |
| 993943 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SCD | 00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe | 4 |
| 993943 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SY | 00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0653-4 | 71335065304 | 60 CAPSULE in 1 BOTTLE (71335-0653-4) | 60 capsule | 2018-01-25 | 0000-00-00 | No | No | Current |