butalbital and acetaminophen

Product NDC: 0603-2540
11-digit product format: 006032540
Labeler code: 0603
Product ID: 0603-2540_2d7cd016-87b7-12bf-e063-6294a90ac288
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA
Application: ANDA089987
Marketing category: ANDA
Marketing start: 1999-06-03
Substance: ACETAMINOPHEN; BUTALBITAL
Active strength: 325; 50 mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS]
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 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
A089987-001	BUTAPAP	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089987-001	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	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089987-001	BUTAPAP	325MG;50MG	TABLET / ORAL	AA	RS	1992-10-26	`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	A089987-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089987-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089987-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089987-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089987-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089987-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089987-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089987-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089987-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089987-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089987-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089987-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089987-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089987-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089987-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089987-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089987-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089987-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089987-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089987-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089987-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089987-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089987-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089987-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089987-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089987-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089987-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089987-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089987-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089987-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089987-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089987-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089987-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089987-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089987-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089987-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089987-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089987-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089987-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089987-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: butalbital and acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197426	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
e619b656-4123-4878-b601-b0edad3c428b	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
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	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
0603-2540-21	butalbital and acetaminophen	100 in 1 BOTTLE	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2540-21	EA - Each	0603-2540	76379aa6-285a-44ed-8a98-f2ad6777b3c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL AND ACETAMINOPHEN TABLET [QUALITEST PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-2540	BUTALBITAL AND ACETAMINOPHEN TABLET [ENDO USA]	7	Current NDC, Legacy NDC, 1 package rows	20250209_e619b656-4123-4878-b601-b0edad3c428b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
butalbital and acetaminophen	BUTALBITAL AND ACETAMINOPHEN	Endo USA	e619b656-4123-4878-b601-b0edad3c428b	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089987 application number: ANDA089987 ndc (product): 0603-2540
Tencon	BUTALBITAL AND ACETAMINOPHEN	El Dorado Distributors LLC	4e4a9925-67aa-4be7-8bb7-c8b058ffe223	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089987 application number: ANDA089987

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197426	butalbital 50 MG / acetaminophen 325 MG Oral Tablet	PSN	e619b656-4123-4878-b601-b0edad3c428b	7
197426	acetaminophen 325 MG / butalbital 50 MG Oral Tablet	SCD	e619b656-4123-4878-b601-b0edad3c428b	7
197426	APAP 325 MG / butalbital 50 MG Oral Tablet	SY	e619b656-4123-4878-b601-b0edad3c428b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2540-21	00603254021	100 TABLET in 1 BOTTLE (0603-2540-21)	100 tablet	1999-06-03	0000-00-00	No	No	Current