Butalbital, Acetaminophen, Caffeine
- Product NDC
- 69367-203
- 11-digit product format
- 693670203
- Labeler code
- 69367
- Product ID
- 69367-203_23d91a38-6b01-4d89-a454-45a9cac1a294
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA209587
- Marketing category
- ANDA
- Marketing start
- 2019-03-05
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Active strength
- 325; 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A209587-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2018-10-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A209587-001 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Butalbital, Acetaminophen, Caffeine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUTALBITAL | 325 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 |
|---|---|
| 238154 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c0511d0-fe63-45c6-8da2-6ceeb56edb17 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69367-203-01 | Butalbital, Acetaminophen, Caffeine | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 69367-203-05 | Butalbital, Acetaminophen, Caffeine | 500 in 1 BOTTLE | TABLET | 500 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69367-203-01 | EA - Each | 69367-203 | 88d12b6d-5662-476b-a61c-628e217a0d1f | 1 | 2019-05-02 |
| 69367-203-05 | EA - Each | 69367-203 | 100815e0-5fd6-48d8-a247-d0b8aab0eee8 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69367-203 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [WESTMINSTER PHARMACEUTICALS, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20220910_1c0511d0-fe63-45c6-8da2-6ceeb56edb17.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | e2978345-826a-47d2-acf3-feb6afb1967e | 106 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | e2978345-826a-47d2-acf3-feb6afb1967e | 106 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | e2978345-826a-47d2-acf3-feb6afb1967e | 106 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 90e166ac-8789-4e7a-b5bb-37c475e3a5b0 | 102 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 90e166ac-8789-4e7a-b5bb-37c475e3a5b0 | 102 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 90e166ac-8789-4e7a-b5bb-37c475e3a5b0 | 102 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 1c0511d0-fe63-45c6-8da2-6ceeb56edb17 | 8 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 1c0511d0-fe63-45c6-8da2-6ceeb56edb17 | 8 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 1c0511d0-fe63-45c6-8da2-6ceeb56edb17 | 8 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | b121190e-db2a-43bb-a57d-b6683a9e2059 | 5 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | b121190e-db2a-43bb-a57d-b6683a9e2059 | 5 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | b121190e-db2a-43bb-a57d-b6683a9e2059 | 5 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | f822c103-b678-4e76-8174-33b94421dd1e | 4 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 2abb9915-edb2-6218-e063-6394a90ad462 | 4 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | d860af16-fab4-4263-9e66-a648d5e81dab | 4 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | f822c103-b678-4e76-8174-33b94421dd1e | 4 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 2abb9915-edb2-6218-e063-6394a90ad462 | 4 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | d860af16-fab4-4263-9e66-a648d5e81dab | 4 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | d860af16-fab4-4263-9e66-a648d5e81dab | 4 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | f822c103-b678-4e76-8174-33b94421dd1e | 4 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 2abb9915-edb2-6218-e063-6394a90ad462 | 4 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 3cf799b4-c785-4ae2-908b-c42e426733dc | 3 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | bd5d031e-e5e2-1671-e053-2995a90a5d5a | 3 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | dc2bb7fc-1722-4865-a02c-be5e5c211505 | 3 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | e5fbd6b8-85e7-8847-e053-2a95a90a52ed | 3 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | bd5d031e-e5e2-1671-e053-2995a90a5d5a | 3 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | dc2bb7fc-1722-4865-a02c-be5e5c211505 | 3 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | e5fbd6b8-85e7-8847-e053-2a95a90a52ed | 3 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 3cf799b4-c785-4ae2-908b-c42e426733dc | 3 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | dc2bb7fc-1722-4865-a02c-be5e5c211505 | 3 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 3cf799b4-c785-4ae2-908b-c42e426733dc | 3 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | e5fbd6b8-85e7-8847-e053-2a95a90a52ed | 3 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | bd5d031e-e5e2-1671-e053-2995a90a5d5a | 3 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2 |
| 238154 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet | PSN | 4871c36f-229b-4c12-e063-6394a90a028e | 1 |
| 238154 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SCD | 4871c36f-229b-4c12-e063-6394a90a028e | 1 |
| 238154 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet | SY | 4871c36f-229b-4c12-e063-6394a90a028e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69367-203-01 | 69367020301 | 100 TABLET in 1 BOTTLE (69367-203-01) | 100 tablet | 2019-03-05 | 0000-00-00 | No | No | Current |
| 69367-203-05 | 69367020305 | 500 TABLET in 1 BOTTLE (69367-203-05) | 500 tablet | 2019-03-05 | 0000-00-00 | No | No | Current |