Methocarbamol

Product NDC: 68071-2563
Requested package NDC: 68071-2563-6
11-digit product format: 680712563
Labeler code: 68071
Product ID: 68071-2563_cff9b7a0-8611-f860-e053-2995a90a2d07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040489
Marketing category: ANDA
Marketing start: 2019-08-15
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2563	68071-2563-6	I	Inactivated by FDA		2026-08-03

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
A040489-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2003-01-29
A040489-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2003-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040489-001	AA
A040489-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`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	A040489-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040489-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040489-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040489-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040489-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040489-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040489-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040489-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040489-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040489-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040489-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040489-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040489-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040489-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040489-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040489-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040489-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040489-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040489-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040489-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040489-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040489-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040489-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040489-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040489-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040489-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040489-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040489-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040489-002	AA	1	`782e0a99824c…`

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 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3d4a2486-863e-4e9f-be3b-67882863e7d4	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6b9ed3a4-46d5-462e-ac93-6b959b314d77	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	adb49cb7-8900-44dc-add0-22e2cd8235ac	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	0deb5368-ffdc-40fc-a97c-ba89b7a97e50	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9617e2b0-4255-4542-95ca-9ee1818ca450	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	8643032a-c491-4ae4-ac46-5e0c4c79dc5b	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	cfdc0d68-00ad-44d6-b932-819cc3d5d60e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	b81a8e64-ae41-409b-94a6-b36cb50bc25d	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	c4744824-4c74-411d-aa8e-c63ee9d89913	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	4ef1c2c0-31e1-4f85-b645-ff47a057a994	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals, Inc	425abc3b-2111-4fac-bf27-b685d1e657af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Direct_rx	4c5c8933-a4b5-f9c2-e063-6294a90a6f00	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	5af36a83-2b36-4fe2-8c6a-61b551621421	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	cc004f5c-d5fc-48c5-9f37-c59b9c37e113	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	9076b4ad-17be-4933-a975-7bf80cc92b49	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3f8aed5d-ba8d-4c32-872b-08ab15240cc1	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	fd8cac57-9664-1fa0-e053-6294a90af872	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	6466438c-4609-4554-8919-35710a1b556d	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	33f89a57-f65d-4e99-a3a3-690ef805d869	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	6af87b4e-6507-4190-b043-a6d3b440314a	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489

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
68071-2563-6	2025-01-30	C162847	48780-1	f386c64a-2cda-0266-e053-dadaa90a7c1a	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
68071-2563-6	2023-07-17	C162847	48780-1	f386c64a-2cda-0266-e053-dadaa90a7c1a	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only
68071-2563-6	2023-01-30	C162847	48780-1	f386c64a-2cda-0266-e053-dadaa90a7c1a	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2563-6	Methocarbamol	6 in 1 BOTTLE	TABLET	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2563	METHOCARBAMOL TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20230718_cff9b44c-618c-4beb-e053-2a95a90a24b0.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
197944	methocarbamol 750 MG Oral Tablet	PSN	cff9b44c-618c-4beb-e053-2a95a90a24b0	2
197944	methocarbamol 750 MG Oral Tablet	SCD	cff9b44c-618c-4beb-e053-2a95a90a24b0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2563-6	68071256306	6 TABLET in 1 BOTTLE (68071-2563-6)	6 tablet	2021-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2