Methocarbamol

Product NDC: 53002-3591
11-digit product format: 530023591
Labeler code: 53002
Product ID: 53002-3591_b775ab12-cad1-4a56-9be8-3dff8b6e1b28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol Tablets
Dosage form: TABLET, COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA209312
Marketing category: ANDA
Marketing start: 2018-07-02
Marketing end: 0000-00-00
Substance: METHOCARBAMOL
Active strength: 750 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-3591		I	Inactivated by FDA	2026-07-31
excluded package	package	53002-3591	53002-3591-2	I	Inactivated by FDA	2026-07-31
excluded package	package	53002-3591	53002-3591-3	I	Inactivated by FDA	2026-07-31
excluded package	package	53002-3591	53002-3591-4	I	Inactivated by FDA	2026-07-31

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
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-3591-2	2025-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-3	2025-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-4	2025-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-2	2023-06-07	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-3	2023-06-07	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-4	2023-06-07	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-2	2023-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-3	2023-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only
53002-3591-4	2023-01-30	C162847	48780-1	f386c649-a06a-0266-e053-dadaa90a7c1a	Methocarbamol Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-3591-2	Methocarbamol	20 in 1 BOTTLE	TABLET, COATED	20	7
53002-3591-3	Methocarbamol	30 in 1 BOTTLE	TABLET, COATED	30	7
53002-3591-4	Methocarbamol	40 in 1 BOTTLE	TABLET, COATED	40	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3591	METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [RPK PHARMACEUTICALS, INC.]	7	Legacy NDC, 3 package rows	20230707_21e2c2ef-3fee-4029-8837-23a476fcad5a.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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3591-2	53002359102	20 TABLET, COATED in 1 BOTTLE (53002-3591-2)	2019-01-01	0000-00-00	No	No	Current
53002-3591-3	53002359103	30 TABLET, COATED in 1 BOTTLE (53002-3591-3)	2019-01-01	0000-00-00	No	No	Current
53002-3591-4	53002359104	40 TABLET, COATED in 1 BOTTLE (53002-3591-4)	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets Rx Only	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	7