Methocarbamol

Product NDC: 67046-0538
11-digit product format: 670460538
Labeler code: 67046
Product ID: 67046-0538_52b861c8-da13-1130-e063-6394a90a8658
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol Tablets
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA209312
Marketing category: ANDA
Marketing start: 2026-05-26
Substance: METHOCARBAMOL
Active strength: 500 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 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
A209312-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07
A209312-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209312-001	AA
A209312-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2018-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`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	A209312-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209312-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209312-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209312-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209312-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209312-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209312-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209312-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209312-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209312-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209312-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209312-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209312-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209312-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209312-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209312-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209312-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209312-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209312-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209312-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209312-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209312-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209312-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209312-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209312-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209312-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209312-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209312-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209312-002	AA	1	`782e0a99824c…`

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 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
52b87514-e6e0-ab57-e063-6394a90a6b23	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
67046-0538-3	Methocarbamol	30 in 1 BLISTER PACK	TABLET, COATED	30		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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	52b20439-6bf4-435e-817a-c3b3fc70846a	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	37767123-8b72-4e1f-b00d-ff3305e9923f	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Unit Dose Solutions, Inc.	561ae476-9e1f-038a-e063-6394a90aa5c7	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Granules Pharmaceuticals Inc.	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Bryant Ranch Prepack	65c460f6-6470-41ff-abb4-d9d54ecc52f7	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	St. Mary's Medical Park Pharmacy	7d4dd78a-f902-6ff2-e053-2991aa0ac7d7	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Preferred Pharmaceuticals Inc.	43f83b87-e169-46fe-98bd-6af373595bd3	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Preferred Pharmaceuticals Inc.	e03878d3-d780-4e7f-b828-20ac2a109933	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Coupler LLC	52b87514-e6e0-ab57-e063-6394a90a6b23	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312 ndc (product): 67046-0538
Methocarbamol	METHOCARBAMOL TABLETS	NuCare Pharmaceuticals,Inc.	71c21226-cd96-33ed-e053-2995a90a5269	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	St. Mary's Medical Park Pharmacy	faa81ad3-2bd2-d637-e053-6294a90a2d36	2026-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Proficient Rx LP	23163bc1-dec7-41f6-baed-eedebfd6be7e	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	1dc3a5b1-c83b-406b-a59d-ce8075e4ccf9	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Advanced Rx of Tennessee, LLC	4de118fe-bd8e-6cc4-e063-6394a90a1320	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Advanced Rx of Tennessee, LLC	4cefe51c-d824-a862-e063-6394a90a7717	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Redpharm Drug	44f264fd-bf40-bed9-e063-6294a90ac44a	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	NuCare Pharmaceuticals,Inc.	72f36d28-15d2-30f6-e053-2a91aa0ad1ce	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Northwind Health Company, LLC	f2b4ed95-0469-393a-e053-2a95a90a98ed	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	31508051-c9cb-149b-e054-00144ff88e88	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312
Methocarbamol	METHOCARBAMOL TABLETS	Northwind Health Company, LLC	f2b4ed5f-3489-9ee4-e053-2995a90a25f0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209312 application number: ANDA209312

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	52b87514-e6e0-ab57-e063-6394a90a6b23	1
197943	methocarbamol 500 MG Oral Tablet	SCD	52b87514-e6e0-ab57-e063-6394a90a6b23	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-0538-3	67046053803	30 TABLET, COATED in 1 BLISTER PACK (67046-0538-3)	2026-05-26	No	No	Current