Butalbital, Acetaminophen, and Caffeine

Product NDC: 71335-0365
11-digit product format: 713350365
Labeler code: 71335
Product ID: 71335-0365_65bc1e24-0409-45ad-8b57-afc73e215114
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA200243
Marketing category: ANDA
Marketing start: 2012-09-13
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0365		I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-0	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-1	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-2	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-3	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-4	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-5	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-6	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-7	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-8	I	Inactivated by FDA	2026-08-11
excluded package	package	71335-0365	71335-0365-9	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 · 165 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	71335-0365-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0365-9	`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	71335-0365-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0365-9	`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	71335-0365-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0365-9	`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	71335-0365-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0365-9	`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	71335-0365-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0365-9	`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	71335-0365-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0365-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0365-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0365-1	`cdf11ea48f46…`	`ba0047e9e063…`

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
A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2012-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200243-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200243-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2012-09-13	`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	A200243-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200243-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200243-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200243-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200243-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200243-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200243-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200243-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200243-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200243-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200243-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200243-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200243-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200243-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200243-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200243-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200243-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200243-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200243-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200243-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200243-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200243-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200243-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200243-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200243-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200243-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200243-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200243-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200243-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200243-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200243-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200243-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200243-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200243-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200243-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200243-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200243-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200243-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200243-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200243-001	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, Effective, Related label table
NDC	Effective	Related label
71335-0365-0	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-1	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-2	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-3	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-4	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-5	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-6	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-7	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-8	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-9	2024-01-30	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-0	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-1	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-2	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-3	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-4	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-5	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-6	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-7	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-8	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-9	2020-02-03	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-0	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-1	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-2	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-3	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-4	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-5	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-6	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-7	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-8	2020-01-31	Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
71335-0365-9	2020-01-31	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
71335-0365-0	Butalbital, Acetaminophen, and Caffeine	84 in 1 BOTTLE	TABLET	84	6
71335-0365-1	Butalbital, Acetaminophen, and Caffeine	20 in 1 BOTTLE	TABLET	20	6
71335-0365-2	Butalbital, Acetaminophen, and Caffeine	30 in 1 BOTTLE	TABLET	30	6
71335-0365-3	Butalbital, Acetaminophen, and Caffeine	60 in 1 BOTTLE	TABLET	60	6
71335-0365-4	Butalbital, Acetaminophen, and Caffeine	90 in 1 BOTTLE	TABLET	90	6
71335-0365-5	Butalbital, Acetaminophen, and Caffeine	50 in 1 BOTTLE	TABLET	50	6
71335-0365-6	Butalbital, Acetaminophen, and Caffeine	6 in 1 BOTTLE	TABLET	6	6
71335-0365-7	Butalbital, Acetaminophen, and Caffeine	120 in 1 BOTTLE	TABLET	120	6
71335-0365-8	Butalbital, Acetaminophen, and Caffeine	40 in 1 BOTTLE	TABLET	40	6
71335-0365-9	Butalbital, Acetaminophen, and Caffeine	12 in 1 BOTTLE	TABLET	12	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0365-0	EA - Each	71335-0365	fcad0810-10cf-4785-821a-f2147a8ba610	1	2018-01-12
71335-0365-1	EA - Each	71335-0365	636009c2-f034-4c29-bcd4-a70fe421aa26	1	2018-01-12
71335-0365-2	EA - Each	71335-0365	e5b7ade3-7c1d-49b1-bf13-e0416d97361c	1	2018-02-20
71335-0365-3	EA - Each	71335-0365	4aba28fe-4b4c-4608-8671-f915ce18b562	1	2018-02-20
71335-0365-4	EA - Each	71335-0365	bbae698b-ea35-444f-8165-b599f87e0098	1	2018-02-20
71335-0365-5	EA - Each	71335-0365	47ed5397-c859-4196-85c1-9bfd9a2440e0	1	2018-02-20
71335-0365-6	EA - Each	71335-0365	868c2662-1c05-4cf9-b4aa-46f5b1afefcb	1	2018-02-20
71335-0365-7	EA - Each	71335-0365	243be282-f145-4af1-a105-45719a1d828e	1	2018-02-20
71335-0365-8	EA - Each	71335-0365	7d150338-98bb-42ba-812b-502422e7b072	1	2018-02-20
71335-0365-9	EA - Each	71335-0365	a267dde9-4523-4caa-8ef7-079354988802	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0365	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [BRYANT RANCH PREPACK]	6	Legacy NDC, 10 package rows	20220129_65bc1e24-0409-45ad-8b57-afc73e215114.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 · 8 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	REMEDYREPACK INC.	bf333509-bf2b-43fa-9eb5-5193e442f328	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Cardinal Health 107, LLC	ab70f3dc-708e-4455-99ff-a2b9fe2d71a3	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Major Pharmaceuticals	0ca49c3c-f2cb-40e3-a7d5-5f48eca59016	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	NuCare Pharmaceuticals, Inc.	4ecb7bdc-4a43-7444-e054-00144ff88e88	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	5b918d6b-94b0-4f9a-ab09-6a511b727de0	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Lannett Company, Inc.	42594152-563e-4984-9901-d6ef3b8a6941	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butal/APAP/Caff	BUTAL/APAP/CAFF	Direct_Rx	f6dc9bbc-3331-b422-e053-6394a90af9a1	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	7a2219a8-8aaf-44ad-9808-b67923df361a	2022-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200243 application number: ANDA200243

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	65bc1e24-0409-45ad-8b57-afc73e215114	6
238154	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SCD	65bc1e24-0409-45ad-8b57-afc73e215114	6
238154	APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet	SY	65bc1e24-0409-45ad-8b57-afc73e215114	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0365-0	71335036500	84 TABLET in 1 BOTTLE (71335-0365-0)	84 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0365-1	71335036501	20 TABLET in 1 BOTTLE (71335-0365-1)	20 tablet	2018-03-23	0000-00-00	No	No	Current
71335-0365-2	71335036502	30 TABLET in 1 BOTTLE (71335-0365-2)	30 tablet	2018-03-19	0000-00-00	No	No	Current
71335-0365-3	71335036503	60 TABLET in 1 BOTTLE (71335-0365-3)	60 tablet	2018-02-28	0000-00-00	No	No	Current
71335-0365-4	71335036504	90 TABLET in 1 BOTTLE (71335-0365-4)	90 tablet	2018-04-19	0000-00-00	No	No	Current
71335-0365-5	71335036505	50 TABLET in 1 BOTTLE (71335-0365-5)	50 tablet	2021-12-27	0000-00-00	No	No	Current
71335-0365-6	71335036506	6 TABLET in 1 BOTTLE (71335-0365-6)	6 tablet	2019-05-16	0000-00-00	No	No	Current
71335-0365-7	71335036507	120 TABLET in 1 BOTTLE (71335-0365-7)	120 tablet	2018-02-15	0000-00-00	No	No	Current
71335-0365-8	71335036508	40 TABLET in 1 BOTTLE (71335-0365-8)	40 tablet	2019-01-14	0000-00-00	No	No	Current
71335-0365-9	71335036509	12 TABLET in 1 BOTTLE (71335-0365-9)	12 tablet	2020-05-21	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	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	6