Application 212623

Type: ANDA
Sponsor: GRANULATION TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	No	No
002	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	750MG	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
A212623-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2021-04-30
A212623-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212623-001	AA
A212623-002	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.

Product history page 1 of 2 · 66 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	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A212623-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212623-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212623-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212623-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212623-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212623-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212623-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212623-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212623-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212623-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212623-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212623-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212623-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212623-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212623-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212623-002	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212623-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212623-002	AA	1	`6a51e52b5d6a…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Medcore LLC	1a6b7327-fd42-4de0-bd0d-2dd478502d52	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Marlex Pharmaceuticals, Inc.	d2e38ac9-1cf3-14ca-e053-2a95a90a8522	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623 ndc (product): 10135-722 ndc (product): 10135-723
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6ca768bf-5095-4148-82d2-a0c2dec16d87	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Bryant Ranch Prepack	dfb0e2ee-fd87-4100-9d44-f7a091e73a6c	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6500c6eb-fa1e-46a5-839f-13047e107e97	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Granulation Technology, Inc.	70c5342c-9597-4fe6-863c-f8ae4adc063a	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	Bryant Ranch Prepack	3d686023-a4a2-4dae-8bfb-1f6b01ca24f0	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-722	Methocarbamol Tablets, USP, 500 mg	Methocarbamol	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-722	Methocarbamol Tablets, USP, 500 mg	Methocarbamol	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-723	Methocarbamol Tablets, USP, 750 mg	Methocarbamol	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-723	Methocarbamol Tablets, USP, 750 mg	Methocarbamol	Marlex Pharmaceuticals, Inc.	ANDA	Current
63561-0107	Methocarbamol Tablets, USP, 500 mg	Methocarbamol	Granulation Technology, Inc.	ANDA	Current
63561-0108	Methocarbamol Tablets, USP, 750 mg	Methocarbamol	Granulation Technology, Inc.	ANDA	Current