Butalbital, Acetaminophen, and Caffeine

Product NDC: 68788-9287
11-digit product format: 687889287
Labeler code: 68788
Product ID: 68788-9287_3c4c8d66-efa6-4831-b656-00ecbe867ece
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA088616
Marketing category: ANDA
Marketing start: 2015-05-08
Marketing end: 0000-00-00
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 50 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9287		I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-1	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-2	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-3	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-6	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-8	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9287	68788-9287-9	I	Inactivated by FDA	2026-08-11

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 3 · 147 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	68788-9287-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9287-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9287-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9287-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9287-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9287-1	`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	68788-9287-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9287-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9287-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9287-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9287-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9287-1	`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	68788-9287-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9287-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9287-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9287-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9287-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9287-1	`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	68788-9287-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9287-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9287-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9287-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9287-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9287-1	`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	68788-9287-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9287-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9287-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9287-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9287-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9287-1	`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	68788-9287-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9287-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9287-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9287-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9287-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9287-1	`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	68788-9287-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9287-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9287-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9287-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9287-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9287-1	`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	68788-9287-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9287-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9287-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9287-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9287-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9287-1	`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	68788-9287-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9287-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9287-9	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68788-9287-1	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-2	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-3	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-6	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-8	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5
68788-9287-9	Butalbital, Acetaminophen, and Caffeine Tablets USP Content Updated: August 2014 Rx only 174241-5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-9287-1	Butalbital, Acetaminophen, and Caffeine	100 in 1 BOTTLE	TABLET	100	4
68788-9287-2	Butalbital, Acetaminophen, and Caffeine	20 in 1 BOTTLE	TABLET	20	4
68788-9287-3	Butalbital, Acetaminophen, and Caffeine	30 in 1 BOTTLE	TABLET	30	4
68788-9287-6	Butalbital, Acetaminophen, and Caffeine	60 in 1 BOTTLE	TABLET	60	4
68788-9287-8	Butalbital, Acetaminophen, and Caffeine	120 in 1 BOTTLE	TABLET	120	4
68788-9287-9	Butalbital, Acetaminophen, and Caffeine	90 in 1 BOTTLE	TABLET	90	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
68788-9287	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC, 6 package rows	20180403_d134544e-e54c-41fd-8c89-d7f017fb0829.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-9287-1	68788928701	100 in 1 BOTTLE	Historical
68788-9287-2	68788928702	20 in 1 BOTTLE	Historical
68788-9287-3	68788928703	30 in 1 BOTTLE	Historical
68788-9287-6	68788928706	60 in 1 BOTTLE	Historical
68788-9287-8	68788928708	120 in 1 BOTTLE	Historical
68788-9287-9	68788928709	90 in 1 BOTTLE	Historical

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	Preferred Pharmaceuticals Inc.	2018-04-02	HUMAN PRESCRIPTION DRUG LABEL	4