Butalbital, Acetaminophen, Caffeine

Product NDC: 68071-2365
11-digit product format: 680712365
Labeler code: 68071
Product ID: 68071-2365_de1f2d42-17ec-34a4-e053-2995a90a3023
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA209587
Marketing category: ANDA
Marketing start: 2019-03-05
Marketing end: 0000-00-00
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]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2365		I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2365	68071-2365-3	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2365	68071-2365-6	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2365	68071-2365-8	I	Inactivated by FDA	2026-08-17
excluded package	package	68071-2365	68071-2365-9	I	Inactivated by FDA	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2365-8	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2365-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2365-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2365-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2365-8	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2365-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2365-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2365-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2365-8	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2365-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2365-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2365-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2365-8	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2365-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2365-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2365-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2365-8	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2365-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2365-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2365-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2365-8	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2365-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2365-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2365-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2365-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2365-8	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2365-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2365-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2365-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2365-8	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2365-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2365-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2365-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2365-8	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2365-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2365-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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
68071-2365-3	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-6	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-8	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
68071-2365-9	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2365-3	Butalbital, Acetaminophen, Caffeine	30 in 1 BOTTLE	TABLET, COATED	30	3
68071-2365-6	Butalbital, Acetaminophen, Caffeine	60 in 1 BOTTLE	TABLET, COATED	60	3
68071-2365-8	Butalbital, Acetaminophen, Caffeine	180 in 1 BOTTLE	TABLET, COATED	180	3
68071-2365-9	Butalbital, Acetaminophen, Caffeine	90 in 1 BOTTLE	TABLET, COATED	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2365	BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]	3	Legacy NDC, 4 package rows	20220824_bd5d031e-e5e2-1671-e053-2995a90a5d5a.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
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	bd5d031e-e5e2-1671-e053-2995a90a5d5a	3
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	bd5d031e-e5e2-1671-e053-2995a90a5d5a	3
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	bd5d031e-e5e2-1671-e053-2995a90a5d5a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2365-3	68071236503	30 TABLET, COATED in 1 BOTTLE (68071-2365-3)	2021-03-12	0000-00-00	No	No	Current
68071-2365-6	68071236506	60 TABLET, COATED in 1 BOTTLE (68071-2365-6)	2021-03-12	0000-00-00	No	No	Current
68071-2365-8	68071236508	180 TABLET, COATED in 1 BOTTLE (68071-2365-8)	2021-03-12	0000-00-00	No	No	Current
68071-2365-9	68071236509	90 TABLET, COATED in 1 BOTTLE (68071-2365-9)	2021-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg	NuCare Pharmaceuticals,Inc.	2022-05-03	HUMAN PRESCRIPTION DRUG LABEL	3