Methocarbamol

Product NDC: 70010-754
11-digit product format: 700100754
Labeler code: 70010
Product ID: 70010-754_31b78323-4baf-4af7-e063-6394a90a2c79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol Tablets
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA209312
Marketing category: ANDA
Marketing start: 2018-07-02
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 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.

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
2026-08-01 22:54:32	2026-06	A209312-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	RS	2018-05-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209312-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	RS	2018-05-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209312-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209312-002	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 70010-754
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
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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197943	Internal RxNorm lookup
197944	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
6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	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
70010-754-01	Methocarbamol	100 in 1 BOTTLE	TABLET, COATED	100		9
70010-754-05	Methocarbamol	500 in 1 BOTTLE	TABLET, COATED	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-754-01	EA - Each	70010-754	a93e091c-1727-4e82-b9fa-fceda19b3402	1	2018-08-13
70010-754-05	EA - Each	70010-754	2371a0a4-be07-42fc-a17f-4211dcd83aaa	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-754	METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [GRANULES PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250403_6f0d3966-962d-fa7c-e053-2a91aa0a8e3c.zip

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	52b20439-6bf4-435e-817a-c3b3fc70846a	20
197943	methocarbamol 500 MG Oral Tablet	SCD	52b20439-6bf4-435e-817a-c3b3fc70846a	20
197943	methocarbamol 500 MG Oral Tablet	PSN	7dafab15-db4c-4425-b1a2-e56433ecccf6	18
197943	methocarbamol 500 MG Oral Tablet	SCD	7dafab15-db4c-4425-b1a2-e56433ecccf6	18
197943	methocarbamol 500 MG Oral Tablet	PSN	5f746f0f-e884-46d9-a104-529293b0fb90	10
197943	methocarbamol 500 MG Oral Tablet	SCD	5f746f0f-e884-46d9-a104-529293b0fb90	10
197943	methocarbamol 500 MG Oral Tablet	PSN	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	9
197944	methocarbamol 750 MG Oral Tablet	PSN	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	9
197943	methocarbamol 500 MG Oral Tablet	SCD	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	9
197944	methocarbamol 750 MG Oral Tablet	SCD	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	9
197943	methocarbamol 500 MG Oral Tablet	PSN	f07c0a35-fb5d-43a1-a33e-d6a51a5fcd77	8
197943	methocarbamol 500 MG Oral Tablet	SCD	f07c0a35-fb5d-43a1-a33e-d6a51a5fcd77	8
197943	methocarbamol 500 MG Oral Tablet	PSN	21e2c2ef-3fee-4029-8837-23a476fcad5a	7
197944	methocarbamol 750 MG Oral Tablet	PSN	21e2c2ef-3fee-4029-8837-23a476fcad5a	7
197943	methocarbamol 500 MG Oral Tablet	SCD	21e2c2ef-3fee-4029-8837-23a476fcad5a	7
197944	methocarbamol 750 MG Oral Tablet	SCD	21e2c2ef-3fee-4029-8837-23a476fcad5a	7
197943	methocarbamol 500 MG Oral Tablet	PSN	72f36d28-15d2-30f6-e053-2a91aa0ad1ce	6
197943	methocarbamol 500 MG Oral Tablet	SCD	72f36d28-15d2-30f6-e053-2a91aa0ad1ce	6
197943	methocarbamol 500 MG Oral Tablet	PSN	e03878d3-d780-4e7f-b828-20ac2a109933	4
197943	methocarbamol 500 MG Oral Tablet	PSN	faa81ad3-2bd2-d637-e053-6294a90a2d36	4
197943	methocarbamol 500 MG Oral Tablet	PSN	270b68a6-1469-190d-e054-00144ff8d46c	4
197943	methocarbamol 500 MG Oral Tablet	PSN	23163bc1-dec7-41f6-baed-eedebfd6be7e	4
197944	methocarbamol 750 MG Oral Tablet	PSN	270b68a6-1469-190d-e054-00144ff8d46c	4
197943	methocarbamol 500 MG Oral Tablet	SCD	e03878d3-d780-4e7f-b828-20ac2a109933	4
197943	methocarbamol 500 MG Oral Tablet	SCD	faa81ad3-2bd2-d637-e053-6294a90a2d36	4
197943	methocarbamol 500 MG Oral Tablet	SCD	270b68a6-1469-190d-e054-00144ff8d46c	4
197943	methocarbamol 500 MG Oral Tablet	SCD	23163bc1-dec7-41f6-baed-eedebfd6be7e	4
197944	methocarbamol 750 MG Oral Tablet	SCD	270b68a6-1469-190d-e054-00144ff8d46c	4
197943	methocarbamol 500 MG Oral Tablet	PSN	44f264fd-bf40-bed9-e063-6294a90ac44a	3
197943	methocarbamol 500 MG Oral Tablet	PSN	73a42c33-d3f4-692b-e053-2a91aa0a6e04	3
197943	methocarbamol 500 MG Oral Tablet	SCD	44f264fd-bf40-bed9-e063-6294a90ac44a	3
197943	methocarbamol 500 MG Oral Tablet	SCD	73a42c33-d3f4-692b-e053-2a91aa0a6e04	3
197943	methocarbamol 500 MG Oral Tablet	PSN	911f8c7a-0a84-7ed8-e053-2995a90a177f	2
197943	methocarbamol 500 MG Oral Tablet	PSN	911f63c2-a6a1-98e9-e053-2995a90a5bb1	2
197943	methocarbamol 500 MG Oral Tablet	PSN	911f1367-bc7c-f752-e053-2a95a90a212b	2
197943	methocarbamol 500 MG Oral Tablet	PSN	f2b4ed95-0469-393a-e053-2a95a90a98ed	2
197943	methocarbamol 500 MG Oral Tablet	PSN	1dc3a5b1-c83b-406b-a59d-ce8075e4ccf9	2
197943	methocarbamol 500 MG Oral Tablet	SCD	f2b4ed95-0469-393a-e053-2a95a90a98ed	2
197943	methocarbamol 500 MG Oral Tablet	SCD	1dc3a5b1-c83b-406b-a59d-ce8075e4ccf9	2
197943	methocarbamol 500 MG Oral Tablet	SCD	911f8c7a-0a84-7ed8-e053-2995a90a177f	2
197943	methocarbamol 500 MG Oral Tablet	SCD	911f63c2-a6a1-98e9-e053-2995a90a5bb1	2
197943	methocarbamol 500 MG Oral Tablet	SCD	911f1367-bc7c-f752-e053-2a95a90a212b	2
197943	methocarbamol 500 MG Oral Tablet	PSN	a8f3b8c4-1d11-93c9-e053-2a95a90aa377	1
197943	methocarbamol 500 MG Oral Tablet	PSN	fe872a3a-fb14-4a0a-b9e4-c9f1885b4978	1
197943	methocarbamol 500 MG Oral Tablet	PSN	4cefe51c-d824-a862-e063-6394a90a7717	1
197943	methocarbamol 500 MG Oral Tablet	PSN	4de118fe-bd8e-6cc4-e063-6394a90a1320	1
197943	methocarbamol 500 MG Oral Tablet	PSN	52b87514-e6e0-ab57-e063-6394a90a6b23	1
197943	methocarbamol 500 MG Oral Tablet	PSN	edbcf8c6-0df8-4e72-885b-16d378f06c7b	1
197943	methocarbamol 500 MG Oral Tablet	PSN	ec95cdba-e226-cd07-e053-2995a90ae04d	1
197944	methocarbamol 750 MG Oral Tablet	PSN	edbcf8c6-0df8-4e72-885b-16d378f06c7b	1
197943	methocarbamol 500 MG Oral Tablet	SCD	edbcf8c6-0df8-4e72-885b-16d378f06c7b	1
197943	methocarbamol 500 MG Oral Tablet	SCD	52b87514-e6e0-ab57-e063-6394a90a6b23	1
197943	methocarbamol 500 MG Oral Tablet	SCD	4de118fe-bd8e-6cc4-e063-6394a90a1320	1
197943	methocarbamol 500 MG Oral Tablet	SCD	ec95cdba-e226-cd07-e053-2995a90ae04d	1
197943	methocarbamol 500 MG Oral Tablet	SCD	4cefe51c-d824-a862-e063-6394a90a7717	1
197943	methocarbamol 500 MG Oral Tablet	SCD	fe872a3a-fb14-4a0a-b9e4-c9f1885b4978	1
197943	methocarbamol 500 MG Oral Tablet	SCD	a8f3b8c4-1d11-93c9-e053-2a95a90aa377	1
197944	methocarbamol 750 MG Oral Tablet	SCD	edbcf8c6-0df8-4e72-885b-16d378f06c7b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-754-01	70010075401	100 TABLET, COATED in 1 BOTTLE (70010-754-01)	2020-02-01	0000-00-00	No	No	Current
70010-754-05	70010075405	500 TABLET, COATED in 1 BOTTLE (70010-754-05)	2020-02-01	0000-00-00	No	No	Current
70010-754-10	70010075410	1000 TABLET, COATED in 1 BOTTLE (70010-754-10)	2020-02-01		0		Current
70010-754-35	70010075435	24 TABLET, COATED in 1 BOTTLE (70010-754-35)	2020-02-01		0		Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	21
Methocarbamol Tablets Rx Only	Unit Dose Solutions, Inc.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets, USP Rx only	Granules Pharmaceuticals Inc. \| Granules India Ltd	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	10
Methocarbamol Tablets Rx Only	Preferred Pharmaceuticals Inc.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	5
Methocarbamol Tablets Rx Only	Coupler LLC	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets Rx Only	St. Mary's Medical Park Pharmacy	2026-05-10	HUMAN PRESCRIPTION DRUG LABEL	5
Methocarbamol Tablets Rx Only	Proficient Rx LP	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	4
Methocarbamol Tablets Rx Only	REMEDYREPACK INC.	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	2
Methocarbamol Tablets Rx Only	Advanced Rx of Tennessee, LLC	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets Rx Only	Advanced Rx of Tennessee, LLC	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets Rx Only	Redpharm Drug	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	3
Methocarbamol Tablets Rx Only	NuCare Pharmaceuticals,Inc.	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	6
Methocarbamol Tablets Rx Only	Northwind Health Company, LLC	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Methocarbamol Tablets Rx Only	A-S Medication Solutions	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	10
Methocarbamol Tablets Rx Only	A-S Medication Solutions	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	8
Methocarbamol Tablets Rx Only	A-S Medication Solutions	2025-06-18	HUMAN PRESCRIPTION DRUG LABEL	1
Methocarbamol Tablets Rx Only	PD-Rx Pharmaceuticals, Inc.	2025-04-15	HUMAN PRESCRIPTION DRUG LABEL	18