Methocarbamol

Product NDC: 35561-349
11-digit product format: 355610349
Labeler code: 35561
Product ID: 35561-349_49fcc548-27fe-58d0-e063-6294a90af96d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bostal LLC
Application: ANDA200958
Marketing category: ANDA
Marketing start: 2022-07-16
Substance: METHOCARBAMOL
Active strength: 1000 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200958-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21
A200958-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21
A200958-003	METHOCARBAMOL	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200958-001	AA
A200958-002	AA
A200958-003	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 4 · 121 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200958-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200958-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200958-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200958-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200958-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200958-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200958-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	AA	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOCARBAMOL	1000 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197943	Internal RxNorm lookup
197944	Internal RxNorm lookup
2611794	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d8f10211-f96e-4cf3-9b49-986eb51b703d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
492965be-47bc-38cf-57c4-5c5e0343abe5	Product name	6	20211028
02a01e9c-3f4e-c0ee-6542-be865127aea3	Product name	8	20190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35561-349-12	Methocarbamol	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		8
35561-349-13	Methocarbamol	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35561-349	METHOCARBAMOL TABLET, COATED [AUSTARPHARMA LLC]	7	Current NDC, 2 package rows	20240807_d8f10211-f96e-4cf3-9b49-986eb51b703d.zip

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
Methocarbamol	METHOCARBAMOL	Misemer Pharmaceutical	e89ae224-ed25-4ae7-e053-2a95a90a9c0e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Bostal LLC	d8f10211-f96e-4cf3-9b49-986eb51b703d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958 ndc (product): 35561-349
Methocarbamol	METHOCARBAMOL	Oncora Pharma, LLC	440d6c99-8aca-af07-e063-6294a90aee3d	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Trifluent Pharma LLC	de2e3af9-03ab-4dc8-b480-6866474ad1bd	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2611794	methocarbamol 1000 MG Oral Tablet	PSN	d8f10211-f96e-4cf3-9b49-986eb51b703d	8
197943	methocarbamol 500 MG Oral Tablet	PSN	d8f10211-f96e-4cf3-9b49-986eb51b703d	8
197944	methocarbamol 750 MG Oral Tablet	PSN	d8f10211-f96e-4cf3-9b49-986eb51b703d	8
2611794	methocarbamol 1000 MG Oral Tablet	SCD	d8f10211-f96e-4cf3-9b49-986eb51b703d	8
197943	methocarbamol 500 MG Oral Tablet	SCD	d8f10211-f96e-4cf3-9b49-986eb51b703d	8
197944	methocarbamol 750 MG Oral Tablet	SCD	d8f10211-f96e-4cf3-9b49-986eb51b703d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
35561-349-12	35561034912	100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-12)	2022-07-16	No	No	Current
35561-349-13	35561034913	500 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-13)	2022-07-16	No	No	Current