Butalbital, Acetaminophen, Caffeine

Product NDC: 50268-553
11-digit product format: 502680553
Labeler code: 50268
Product ID: 50268-553_2b4a7d93-e919-27be-e063-6294a90a1db0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA209587
Marketing category: ANDA
Marketing start: 2022-08-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	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#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Butalbital, Acetaminophen, Caffeine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	50 mg/1
ACETAMINOPHEN	325 mg/1
CAFFEINE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KHS0AZ4JVK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238154	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e5fbd6b8-85e7-8847-e053-2a95a90a52ed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-553-11	Butalbital, Acetaminophen, Caffeine	1 in 1 BLISTER PACK	TABLET	1		3
50268-553-13	Butalbital, Acetaminophen, Caffeine	30 in 1 BOX	TABLET	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-553-11	EA - Each	50268-553	90bf7986-3279-448f-9868-db8e333b5dcc	1	2022-09-12
50268-553-13	EA - Each	50268-553	c98dc43f-9abf-452e-beed-5515649e9252	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-553	BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20250112_e5fbd6b8-85e7-8847-e053-2a95a90a52ed.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.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Preferred Pharmaceuticals Inc.	b121190e-db2a-43bb-a57d-b6683a9e2059	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: 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	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	REMEDYREPACK INC.	dc2bb7fc-1722-4865-a02c-be5e5c211505	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Asclemed USA, Inc.	cce09e09-158f-4927-8a3e-4ec9334f0b7a	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
BUTAL/APAP/CAFFEINE	BUTAL/APAP/CAFFEINE	Direct_Rx	2abb9915-edb2-6218-e063-6394a90ad462	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	AvPAK	e5fbd6b8-85e7-8847-e053-2a95a90a52ed	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587 ndc (product): 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	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	e2978345-826a-47d2-acf3-feb6afb1967e	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: 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	Exact identifier application applno (ANDA): 209587 application number: 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	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	d860af16-fab4-4263-9e66-a648d5e81dab	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	90e166ac-8789-4e7a-b5bb-37c475e3a5b0	2023-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Westminster Pharmaceuticals, LLC	1c0511d0-fe63-45c6-8da2-6ceeb56edb17	2019-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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	e5fbd6b8-85e7-8847-e053-2a95a90a52ed	3
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	e5fbd6b8-85e7-8847-e053-2a95a90a52ed	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-553-11	50268055311	1 in 1 BLISTER PACK						Historical
50268-553-13	50268055313	30 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11)	30 blister pack	2022-08-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP	AvPAK	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	3