Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Product NDC: 0722-7028
11-digit product format: 007227028
Labeler code: 0722
Product ID: 0722-7028_9465cf48-74b4-4615-83ef-4a3724c5f9e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: Nexgen Pharma, Inc.
Application: ANDA076560
Marketing category: ANDA
Marketing start: 2004-06-10
Marketing end: 0000-00-00
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
Active strength: 50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0722-7028		I	Inactivated by FDA	2026-08-17
excluded package	package	0722-7028	0722-7028-01	I	Inactivated by FDA	2026-08-17
excluded package	package	0722-7028	0722-7028-05	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 · 57 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	0722-7028-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0722-7028-05	`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	0722-7028-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0722-7028-05	`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	0722-7028-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0722-7028-05	`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	0722-7028-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0722-7028-05	`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	0722-7028-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0722-7028-05	`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	0722-7028-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0722-7028-05	`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	0722-7028-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0722-7028-05	`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	0722-7028-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0722-7028-05	`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	0722-7028-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0722-7028-05	`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	0722-7028-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0722-7028-05	`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	0722-7028-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0722-7028-05	`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	0722-7028-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0722-7028-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0722-7028-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0722-7028-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0722-7028-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0722-7028-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0722-7028-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0722-7028-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0722-7028-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0722-7028-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0722-7028-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0722-7028-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0722-7028-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0722-7028-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0722-7028-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0722-7028-05	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2004-06-10
A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2012-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076560-001	AB
A076560-002	AB

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 3 · 84 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	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL		2012-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2012-07-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A076560-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076560-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076560-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076560-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076560-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076560-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076560-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076560-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076560-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076560-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076560-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076560-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076560-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076560-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076560-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076560-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076560-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076560-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076560-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076560-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076560-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076560-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076560-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076560-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076560-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076560-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076560-001	AB	1	`782e0a99824c…`

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
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	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
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0722-7028-01	2021-07-23	C162847	48780-1	c7ccaba7-1d8b-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992
0722-7028-05	2021-07-23	C162847	48780-1	c7ccaba7-1d8b-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0722-7028-01	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		11
0722-7028-05	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0722-7028	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]	11	Legacy NDC, 2 package rows	20200223_8f8c5c01-5859-4843-adf4-8116ddaedc90.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	15a34df5-e48f-4570-9232-80e4093c4624	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	Actavis Pharma, Inc.	52321fe5-c001-4e2d-8149-3197ddc13764	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Breckenridge Pharmaceutical, Inc.	d74db417-d2de-495b-bb75-46a83745603d	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	LGM PHARMA SOLUTIONS, LLC	180d20a5-78a8-4faa-98ad-3196cdd5663a	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560
Fioricet with Codeine	BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE	Actavis Pharma, Inc.	df9801fc-03fe-41da-a6b3-0f76788217c9	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076560 application number: ANDA076560

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
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1431286	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	8f8c5c01-5859-4843-adf4-8116ddaedc90	11
1431286	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	8f8c5c01-5859-4843-adf4-8116ddaedc90	11
1431286	APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule	SY	8f8c5c01-5859-4843-adf4-8116ddaedc90	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0722-7028-01	00722702801	100 CAPSULE in 1 BOTTLE, PLASTIC (0722-7028-01)	100 capsule	2004-06-10	0000-00-00	No	No	Current
0722-7028-05	00722702805	500 CAPSULE in 1 BOTTLE, PLASTIC (0722-7028-05)	500 capsule	2004-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Nexgen Pharma, Inc.	2020-02-21	HUMAN PRESCRIPTION DRUG LABEL	11