Application 213046

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

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

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
A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA		2020-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213046-001	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.

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	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213046-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213046-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213046-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213046-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213046-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213046-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213046-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213046-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213046-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213046-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213046-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213046-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213046-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213046-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213046-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213046-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213046-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213046-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213046-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213046-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213046-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213046-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213046-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213046-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213046-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213046-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213046-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213046-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213046-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213046-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213046-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213046-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213046-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213046-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213046-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213046-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213046-001	AA	1	`a50c72e98297…`

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 and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Sun Pharmaceutical Industries, Inc.	a68de112-f5af-49ba-a8a8-3adbaa7df36e	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213046 application number: ANDA213046 ndc (product): 51672-4222

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-170	Butalbital, Acetaminophen, and Caffeine	Butalbital, Acetaminophen, and Caffeine	NORTHSTAR RX LLC	ANDA	Current
51672-4222	Butalbital, Acetaminophen and Caffeine	butalbital, acetaminophen, and caffeine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4222	Butalbital, Acetaminophen and Caffeine	butalbital, acetaminophen, and caffeine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current