Zebutal

Product NDC: 68308-554
11-digit product format: 683080554
Labeler code: 68308
Product ID: 68308-554_ea23bc04-96ae-45e8-e053-2a95a90acd45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA089007
Marketing category: ANDA
Marketing start: 2013-12-26
Marketing end: 2023-10-31
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 325 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: 0000-00-00
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68308-554		D	Discontinued by firm		2026-08-17
excluded package	package	68308-554	68308-554-10	D	Discontinued by firm		2026-08-17

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.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68308-554-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68308-554-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68308-554-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68308-554-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68308-554-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68308-554-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68308-554-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68308-554-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68308-554-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68308-554-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68308-554-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68308-554-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089007-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089007-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	CAPSULE / ORAL	AA	RS	1986-03-17	`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	A089007-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089007-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089007-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089007-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089007-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089007-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089007-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089007-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089007-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089007-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089007-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089007-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089007-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089007-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089007-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089007-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089007-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089007-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089007-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089007-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089007-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089007-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089007-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089007-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089007-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089007-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089007-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089007-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089007-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089007-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089007-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089007-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089007-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089007-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089007-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089007-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089007-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089007-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089007-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089007-001	AA	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-554-10	EA - Each	68308-554	73e70e70-ba1a-4315-8db9-501a79cd1184	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZEBUTAL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MIDLOTHIAN LABORATORIES]	1

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, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Mayne Pharma	fa88f437-830b-48bc-a44c-fd142963a150	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089007 application number: ANDA089007
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Dr. Reddy's Labratories Inc.	69df02fa-c842-48dc-7ac6-5967b7dc30de	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089007 application number: ANDA089007

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-554-10	68308055410	100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10)	100 capsule	2013-12-26	0000-00-00	No	No	Current