Butalbital, Acetaminophen, and Caffeine

Product NDC: 0591-3369
11-digit product format: 005913369
Labeler code: 0591
Product ID: 0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA088616
Marketing category: ANDA
Marketing start: 2007-12-13
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]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088616-001	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 · 41 observed states.

Captured, Edition, Application-product table
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	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1984-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088616-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RLD	1984-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088616-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088616-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088616-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088616-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088616-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088616-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088616-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088616-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088616-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088616-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088616-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088616-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088616-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088616-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088616-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088616-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088616-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088616-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088616-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088616-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088616-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088616-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088616-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088616-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088616-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088616-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088616-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088616-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088616-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088616-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088616-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088616-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088616-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088616-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088616-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088616-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088616-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088616-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088616-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088616-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Butalbital, Acetaminophen, and Caffeine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	325 mg/1
ACETAMINOPHEN	50 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
a6cbc17f-5c60-489c-8029-84b0add556d8	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
0591-3369-01	Butalbital, Acetaminophen, and Caffeine	100 in 1 BOTTLE	TABLET	100		17
0591-3369-05	Butalbital, Acetaminophen, and Caffeine	500 in 1 BOTTLE	TABLET	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3369-01	EA - Each	0591-3369	f9f4172c-decd-40ed-acbe-c081dc5f5be4	1	2012-07-24
0591-3369-05	EA - Each	0591-3369	c7c0d508-3196-4bf7-b2d9-170d30fb9d3d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	423
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	12
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3369	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20241114_a6cbc17f-5c60-489c-8029-84b0add556d8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Actavis Pharma, Inc.	a6cbc17f-5c60-489c-8029-84b0add556d8	2014-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088616 application number: ANDA088616 ndc (product): 0591-3369

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	a6cbc17f-5c60-489c-8029-84b0add556d8	17
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	a6cbc17f-5c60-489c-8029-84b0add556d8	17
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	a6cbc17f-5c60-489c-8029-84b0add556d8	17
238154	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet	PSN	9a9fe1f1-eafd-44c9-923b-bea787b5e7e0	7
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	9a9fe1f1-eafd-44c9-923b-bea787b5e7e0	7
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	9a9fe1f1-eafd-44c9-923b-bea787b5e7e0	7
238154	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet	PSN	d134544e-e54c-41fd-8c89-d7f017fb0829	4
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	d134544e-e54c-41fd-8c89-d7f017fb0829	4
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	d134544e-e54c-41fd-8c89-d7f017fb0829	4
238154	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet	PSN	673648ec-81ea-4f9f-a988-19016683aa6d	2
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	673648ec-81ea-4f9f-a988-19016683aa6d	2
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	673648ec-81ea-4f9f-a988-19016683aa6d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3369-01	00591336901	100 TABLET in 1 BOTTLE (0591-3369-01)	100 tablet	2007-12-13	0000-00-00	No	No	Current
0591-3369-05	00591336905	500 TABLET in 1 BOTTLE (0591-3369-05)	500 tablet	2007-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital , Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5	Unit Dose Services	2018-04-03	HUMAN PRESCRIPTION DRUG LABEL	2
Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5	Preferred Pharmaceuticals Inc.	2018-04-02	HUMAN PRESCRIPTION DRUG LABEL	4
Butalbital , Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5	A-S Medication Solutions	2017-09-27	HUMAN PRESCRIPTION DRUG LABEL	7
Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5	Actavis Pharma, Inc.	2014-08-21	HUMAN PRESCRIPTION DRUG LABEL	17
Butalbital-Acetaminophen-Caffeine 50mg/325mg/40mg	Lake Erie Medical DBA Quality Care Products LLC \| Watson Laboratories Inc	2010-10-11	HUMAN PRESCRIPTION DRUG LABEL	423