Application 215138

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	325MG;50MG;40MG;30MG	No	No
002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	300MG;50MG;40MG;30MG	No	No

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
A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2022-01-26
A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB		2022-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215138-001	AB
A215138-002	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 2 · 64 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	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215138-001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215138-002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	300MG;50MG;40MG;30MG	CAPSULE / ORAL	AB	2022-01-26	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A215138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215138-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215138-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215138-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215138-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215138-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215138-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215138-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215138-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215138-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215138-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215138-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215138-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215138-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215138-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215138-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215138-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215138-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215138-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215138-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215138-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215138-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215138-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215138-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215138-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215138-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215138-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215138-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215138-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215138-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215138-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215138-002	AB	1	`1c564ffb4f44…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Hikma Pharmaceuticals USA Inc.	6e0e8abc-512b-42f7-8323-434c589edecf	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215138 application number: ANDA215138 ndc (product): 0054-3000 ndc (product): 0054-0650

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3000	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3000	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76483	ORIG	2023-11-07