Application 202068

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHIMAZOLE	METHIMAZOLE	TABLET;ORAL	5MG	No	No
002	METHIMAZOLE	METHIMAZOLE	TABLET;ORAL	10MG	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
A202068-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2012-03-07
A202068-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB		2012-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202068-001	AB
A202068-002	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	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202068-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202068-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202068-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202068-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202068-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202068-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202068-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202068-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202068-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202068-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202068-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202068-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202068-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202068-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202068-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	253088bf-00f2-489b-984a-682ef9d89e90	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	f74a8e69-79a1-4061-b42f-447e0780c04f	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068
Methimazole	METHIMAZOLE	Rising Pharma Holdings, Inc.	289ec852-176e-41aa-9f9a-b1f9b4196771	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068

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
53808-1044	METHIMAZOLE	METHIMAZOLE	State of Florida DOH Central Pharmacy	ANDA	Current
64980-260	Methimazole	methimazole	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-261	Methimazole	methimazole	Rising Pharmaceuticals, Inc.	ANDA	Current
68788-0681	METHIMAZOLE	METHIMAZOLE	Preferred Pharmaceuticals, Inc.	ANDA	Current