Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Product NDC: 51991-073
11-digit product format: 519910073
Labeler code: 51991
Product ID: 51991-073_2e57797a-2cd4-4f32-ae8b-2db74f699b61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Dosage form: CAPSULE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA076560
Marketing category: ANDA
Marketing start: 2004-07-01
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength: 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A076560-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2004-06-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076560-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL		2012-07-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 73 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	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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076560-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076560-001	AB	1	`5aa47cf7b7d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	325 mg/1
ACETAMINOPHEN	50 mg/1
CAFFEINE	40 mg/1
CODEINE PHOSPHATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KHS0AZ4JVK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
3G6A5W338E	Internal UNII lookup
GSL05Y1MN6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993943	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d74db417-d2de-495b-bb75-46a83745603d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
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
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
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
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
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
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51991-073-01	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-073-01	EA - Each	51991-073	663eab42-79d4-4653-bc98-0fe9ec4d3f12	1	2012-07-24

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 [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Butalbital	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Butalbital	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Caffeine	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Caffeine	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Butalbital	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Butalbital	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Caffeine	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Caffeine	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Codeine	ACTIVE MOIETY	Q830PW7520	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Codeine	ACTIVE MOIETY	Q830PW7520	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-073	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20250115_d74db417-d2de-495b-bb75-46a83745603d.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 ndc (product): 51991-073
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
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
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
993943	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	101
993943	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	101
993943	APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SY	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	101
993943	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	d74db417-d2de-495b-bb75-46a83745603d	11
993943	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	d74db417-d2de-495b-bb75-46a83745603d	11
993943	APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SY	d74db417-d2de-495b-bb75-46a83745603d	11
993943	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	15a34df5-e48f-4570-9232-80e4093c4624	10
993943	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	15a34df5-e48f-4570-9232-80e4093c4624	10
993943	APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SY	15a34df5-e48f-4570-9232-80e4093c4624	10
993943	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	PSN	7fd761e6-64fe-44cc-8b74-10ce31ccfd66	2
993943	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SCD	7fd761e6-64fe-44cc-8b74-10ce31ccfd66	2
993943	APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule	SY	7fd761e6-64fe-44cc-8b74-10ce31ccfd66	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-073-01	51991007301	100 CAPSULE in 1 BOTTLE, PLASTIC (51991-073-01)	100 capsule	2004-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Bryant Ranch Prepack	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	10
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Breckenridge Pharmaceutical, Inc. \| LGM Pharma Solutions, LLC	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	11
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	101
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules CIII	Dispensing Solutions, Inc.	2011-10-03	HUMAN PRESCRIPTION DRUG LABEL	2