Methocarbamol

Product NDC: 71335-2794
Requested package NDC: 71335-2794-9
11-digit product format: 713352794
Labeler code: 71335
Product ID: 71335-2794_cfe925e8-f1dc-4ece-87c4-75ba2c7eddca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213967
Marketing category: ANDA
Marketing start: 2023-02-09
Substance: METHOCARBAMOL
Active strength: 500 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213967-001	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2020-08-12
A213967-002	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2023-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213967-001	AA
A213967-002	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 · 64 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
2026-09-14 22:38:34	2026-08	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213967-002	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2023-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL		2020-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213967-001	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2020-08-12	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A213967-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213967-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213967-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213967-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213967-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213967-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213967-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213967-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213967-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213967-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213967-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213967-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213967-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213967-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213967-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213967-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213967-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213967-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213967-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213967-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213967-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213967-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213967-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213967-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213967-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213967-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213967-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213967-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213967-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213967-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213967-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213967-002	AA	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A213967-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213967-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213967-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213967-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213967-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213967-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213967-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213967-001	AA	1	`ea1830bbd6c7…`

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: 2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197943	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
fdea0332-1ad8-40ef-8cb9-b3c46588155d	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	SPL version
71335-2794-0	Methocarbamol	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
71335-2794-1	Methocarbamol	14 in 1 BOTTLE	TABLET, FILM COATED	14	1
71335-2794-2	Methocarbamol	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71335-2794-3	Methocarbamol	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
71335-2794-4	Methocarbamol	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71335-2794-5	Methocarbamol	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
71335-2794-6	Methocarbamol	40 in 1 BOTTLE	TABLET, FILM COATED	40	1
71335-2794-7	Methocarbamol	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
71335-2794-8	Methocarbamol	120 in 1 BOTTLE	TABLET, FILM COATED	120	1
71335-2794-9	Methocarbamol	7 in 1 BOTTLE	TABLET, FILM COATED	7	1

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	56090def-7caf-e916-e063-6294a90a6ac2	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Redpharm Drug	44f2aa92-4619-021e-e063-6394a90a296c	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Sportpharm LLC	64a06ef2-a062-49cc-9526-03c22b6ced2c	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals,Inc.	36c2c31c-8648-7723-e063-6294a90aec98	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	7f297ac6-a580-4539-a770-fe5d15c2b922	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f7ab7f11-9b5a-4d3a-a8fc-eee55b1fc006	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	fdea0332-1ad8-40ef-8cb9-b3c46588155d	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967 ndc (package): 71335-2794-9 ndc (product): 71335-2794 ndc11 (package): 71335279409
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	3b199152-bafc-e14a-e063-6394a90ab283	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	9169399e-bca1-4c44-9a93-886f3650e44d	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	38d8b457-0c0f-45cb-bf90-965c5a01b198	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	NCS HealthCare of KY, LLC dba Vangard Labs	32ea8117-4a35-4e2c-93bc-866544b2c3be	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967
Methocarbamol	METHOCARBAMOL	Aurobindo Pharma Limited	f83dd093-ea53-44c1-a40d-682ebc494b62	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213967 application number: ANDA213967

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
197943	methocarbamol 500 MG Oral Tablet	PSN	fdea0332-1ad8-40ef-8cb9-b3c46588155d	1
197943	methocarbamol 500 MG Oral Tablet	SCD	fdea0332-1ad8-40ef-8cb9-b3c46588155d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2794-9	71335279409	7 TABLET, FILM COATED in 1 BOTTLE (71335-2794-9)	2025-10-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP Rx only	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1