Methocarbamol

Product NDC: 82461-722
Requested package NDC: 82461-722-90
11-digit product format: 824610722
Labeler code: 82461
Product ID: 82461-722_1745e58f-e6fb-43d8-a738-74a2cc80db48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medcore LLC
Application: ANDA212623
Marketing category: ANDA
Marketing start: 2026-07-31
Substance: METHOCARBAMOL
Active strength: 500 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
Listing certified through: 2027-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methocarbamol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOCARBAMOL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
125OD7737X	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1a6b7327-fd42-4de0-bd0d-2dd478502d52	Available on FDA.report

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 ndc (package): 82461-722-90 ndc (product): 82461-722 ndc11 (package): 82461072290
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
125OD7737X	METHOCARBAMOL	532-03-6	METHOCARBAMOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
82461-722-90	82461072290	90 TABLET, FILM COATED in 1 BOTTLE (82461-722-90)	2026-07-31	0	Current