Methocarbamol Tablets, USP, 500 mg

Product NDC: 72789-499
Requested package NDC: 72789-499-20
11-digit product format: 727890499
Labeler code: 72789
Product ID: 72789-499_396bde13-ddeb-7ed6-e063-6294a90abdd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA212623
Marketing category: ANDA
Marketing start: 2024-01-01
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
A212623-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2021-04-30
A212623-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212623-001	AA
A212623-002	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 · 70 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	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212623-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2021-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212623-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2021-04-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A212623-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212623-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212623-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212623-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212623-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212623-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212623-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212623-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212623-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212623-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212623-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212623-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212623-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212623-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212623-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212623-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212623-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212623-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212623-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212623-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212623-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212623-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212623-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212623-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212623-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212623-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212623-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212623-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212623-002	AA	1	`bb7c543d1eb4…`

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 Tablets, USP, 500 mg
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
6500c6eb-fa1e-46a5-839f-13047e107e97	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
72789-499-18	Methocarbamol Tablets, USP, 500 mg	18 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	18	4
72789-499-20	Methocarbamol Tablets, USP, 500 mg	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	4
72789-499-28	Methocarbamol Tablets, USP, 500 mg	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-499-18	EA - Each	72789-499	1d600402-338f-4168-8e69-7654397e2500	1	2025-06-13
72789-499-20	EA - Each	72789-499	5008ab11-2368-4780-bd0a-01f48b1a9a37	1	2025-06-13
72789-499-28	EA - Each	72789-499	ae9db331-7874-40f7-ae75-a2ec691eb082	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-499	METHOCARBAMOL TABLETS, USP, 500 MG (METHOCARBAMOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3	Current NDC, 3 package rows	20250429_6500c6eb-fa1e-46a5-839f-13047e107e97.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Medcore LLC	1a6b7327-fd42-4de0-bd0d-2dd478502d52	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Marlex Pharmaceuticals, Inc.	d2e38ac9-1cf3-14ca-e053-2a95a90a8522	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6ca768bf-5095-4148-82d2-a0c2dec16d87	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Bryant Ranch Prepack	dfb0e2ee-fd87-4100-9d44-f7a091e73a6c	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6500c6eb-fa1e-46a5-839f-13047e107e97	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623 ndc (package): 72789-499-20 ndc (product): 72789-499 ndc11 (package): 72789049920
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Granulation Technology, Inc.	70c5342c-9597-4fe6-863c-f8ae4adc063a	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	Bryant Ranch Prepack	3d686023-a4a2-4dae-8bfb-1f6b01ca24f0	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212623 application number: ANDA212623

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	6500c6eb-fa1e-46a5-839f-13047e107e97	4
197943	methocarbamol 500 MG Oral Tablet	SCD	6500c6eb-fa1e-46a5-839f-13047e107e97	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-499-20	72789049920	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-499-20)	2025-04-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP, 500 mg	PD-Rx Pharmaceuticals, Inc.	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	4