Methocarbamol

Product NDC: 43353-948
Requested package NDC: 43353-948-92
11-digit product format: 433530948
Labeler code: 43353
Product ID: 43353-948_e0ec118f-42c9-4651-892c-9cba0412f99a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA200958
Marketing category: ANDA
Marketing start: 2014-02-20
Marketing end: 0000-00-00
Substance: METHOCARBAMOL
Active strength: 500 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	43353-948	43353-948-92	I	Inactivated by FDA		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200958-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21
A200958-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21
A200958-003	METHOCARBAMOL	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200958-001	AA
A200958-002	AA
A200958-003	AB

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 · 115 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	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2011-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-003	METHOCARBAMOL	1GM	TABLET / ORAL	AB	RS	2021-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200958-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2011-10-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 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	A200958-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200958-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200958-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200958-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200958-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200958-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200958-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200958-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200958-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200958-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200958-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200958-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200958-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200958-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200958-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200958-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200958-001	AA	1	`8072bd15b7f6…`

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, Related label table
NDC	Related label
43353-948-30	Methocarbamol tablet, film coated 500 mg
43353-948-53	Methocarbamol tablet, film coated 500 mg
43353-948-60	Methocarbamol tablet, film coated 500 mg
43353-948-70	Methocarbamol tablet, film coated 500 mg
43353-948-80	Methocarbamol tablet, film coated 500 mg
43353-948-90	Methocarbamol tablet, film coated 500 mg
43353-948-92	Methocarbamol tablet, film coated 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-948-30	Methocarbamol	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
43353-948-53	Methocarbamol	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
43353-948-60	Methocarbamol	90 in 1 BOTTLE	TABLET, FILM COATED	90	3
43353-948-70	Methocarbamol	120 in 1 BOTTLE	TABLET, FILM COATED	120	3
43353-948-80	Methocarbamol	180 in 1 BOTTLE	TABLET, FILM COATED	180	3
43353-948-90	Methocarbamol	240 in 1 BOTTLE	TABLET, FILM COATED	240	3
43353-948-92	Methocarbamol	270 in 1 BOTTLE	TABLET, FILM COATED	270	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-948-30	EA - Each	43353-948	1536e03b-e863-49b6-8259-3804c2f4da37	1	2016-06-14
43353-948-53	EA - Each	43353-948	8fb8ecb4-5874-408d-a197-33eb5ede1322	1	2016-06-14
43353-948-60	EA - Each	43353-948	f990c0d6-1a43-46b4-be4a-90bbf16641fd	1	2016-06-14
43353-948-70	EA - Each	43353-948	1f464b12-56df-436b-b99c-d0de359eee55	1	2016-06-14
43353-948-80	EA - Each	43353-948	7812f6ce-698d-429d-8e90-0aa9755a1211	1	2016-06-14
43353-948-90	EA - Each	43353-948	074a05f8-353f-4ed8-ba99-a5eee57b779e	1	2016-06-14
43353-948-92	EA - Each	43353-948	5e265845-7f21-4726-b238-bca2b6360a99	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-948	METHOCARBAMOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 7 package rows	20191221_d97eb176-9f3e-4850-a2ed-0580380260d3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Misemer Pharmaceutical	e89ae224-ed25-4ae7-e053-2a95a90a9c0e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Bostal LLC	d8f10211-f96e-4cf3-9b49-986eb51b703d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Oncora Pharma, LLC	440d6c99-8aca-af07-e063-6294a90aee3d	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958
Methocarbamol	METHOCARBAMOL	Trifluent Pharma LLC	de2e3af9-03ab-4dc8-b480-6866474ad1bd	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200958 application number: ANDA200958

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	d97eb176-9f3e-4850-a2ed-0580380260d3	3
197943	methocarbamol 500 MG Oral Tablet	SCD	d97eb176-9f3e-4850-a2ed-0580380260d3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-948-92	43353094892	270 TABLET, FILM COATED in 1 BOTTLE (43353-948-92)	2014-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol tablet, film coated 500 mg	Aphena Pharma Solutions - Tennessee, LLC	2019-12-20	HUMAN PRESCRIPTION DRUG LABEL	3