Methocarbamol

Product NDC: 43353-779
11-digit product format: 433530779
Labeler code: 43353
Product ID: 43353-779_048d999c-3507-43e8-ac09-b9013ac06e38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methocarbamol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040489
Marketing category: ANDA
Marketing start: 2003-01-29
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: 2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-779		I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-30	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-53	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-60	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-70	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-80	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-90	I	Inactivated by FDA	2026-10-05
excluded package	package	43353-779	43353-779-92	I	Inactivated by FDA	2026-10-05

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 3 · 168 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-779-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-779-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-779-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-779-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-779-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-779-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-779-80	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-779-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-779-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-779-70	`ed331223b511…`	`672a5bd82f5f…`

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
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 · 86 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	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040489-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2003-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040489-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2003-01-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A040489-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040489-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040489-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040489-002	AA	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
43353-779-30	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-53	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-60	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-70	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-80	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-90	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
43353-779-92	Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-779-30	Methocarbamol	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
43353-779-53	Methocarbamol	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
43353-779-60	Methocarbamol	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
43353-779-70	Methocarbamol	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
43353-779-80	Methocarbamol	180 in 1 BOTTLE, PLASTIC	TABLET	180	2
43353-779-90	Methocarbamol	240 in 1 BOTTLE, PLASTIC	TABLET	240	2
43353-779-92	Methocarbamol	270 in 1 BOTTLE, PLASTIC	TABLET	270	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-779-30	EA - Each	43353-779	6f94b95a-6c74-4fb1-8874-87c9d981aca3	1	2014-06-03
43353-779-53	EA - Each	43353-779	55800a69-618e-43f1-a1fd-651ba36a2e8f	1	2014-06-03
43353-779-60	EA - Each	43353-779	00b42573-3ee6-4078-97e6-c0f9b00e7130	1	2014-06-03
43353-779-70	EA - Each	43353-779	2bd957f4-71a6-431f-8046-0581d5e5a1cc	1	2014-06-03
43353-779-80	EA - Each	43353-779	e2b1b166-53b5-423f-8c6c-63b8f53a3456	1	2014-06-03
43353-779-90	EA - Each	43353-779	2ae12869-3d7e-4724-8d57-c416afb38c03	1	2015-05-05
43353-779-92	EA - Each	43353-779	013b9fe9-d0b0-4c66-adb5-897d35b80f6a	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOCARBAMOL	ACTIVE INGREDIENT	125OD7737X	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
METHOCARBAMOL	ACTIVE MOIETY	125OD7737X	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-779	METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 7 package rows	20140509_cb9d6493-374a-439a-b322-5c289e0f4109.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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Doc Rx	f4956165-3605-4ff3-9fd1-70157edc08ca	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Oxford Pharmaceuticals, LLC	06dc72a6-ef3a-425a-9194-a9d228093cc4	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	b72a3fff-9710-4c60-8ca6-ed428377fc24	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	d3448618-c9b4-4cb9-a30e-1afc8197cfe1	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	ASCLEMED USA INC.	077fa923-bee0-4b34-a52d-6f870bcb4828	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	311c79a5-1447-4fef-8726-ae003ef64db5	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	4b1d8ac6-d25d-1c37-e063-6394a90aba29	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	4abc29e9-a0cc-06cf-e063-6294a90ad874	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	39bc9ecf-837e-5bb8-e063-6394a90a917e	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Doc Rx	5e55526f-bb34-4b67-85ea-b2765e8066bb	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	GENTEX PHARMA, LLC	35c044a6-90c0-55f8-e063-6294a90aad48	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	2cf76cdc-820d-1c5b-e063-6294a90a35aa	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Redpharm Drug, Inc.	09d22ef9-a472-4db9-e063-6394a90a8870	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
METHOCARBAMOL	METHOCARBAMOL	DirectRx	ceb428e0-d6e4-57b7-e053-2995a90afcda	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	afc9d84d-c8dd-05c0-e053-2a95a90a22a2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	f6567e04-12f0-fa79-e053-2995a90a9a0e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8c18ffef-b2c5-4af2-af66-e22c168e7680	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Key Therapeutics	a88a6c84-b55a-4b6b-ac01-554079f6e304	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489
Methocarbamol	METHOCARBAMOL	Key Therapeutics	cf931001-95bd-4900-98d5-f5ef54b49d99	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040489 application number: ANDA040489

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	cb9d6493-374a-439a-b322-5c289e0f4109	2
197944	methocarbamol 750 MG Oral Tablet	PSN	cb9d6493-374a-439a-b322-5c289e0f4109	2
197943	methocarbamol 500 MG Oral Tablet	SCD	cb9d6493-374a-439a-b322-5c289e0f4109	2
197944	methocarbamol 750 MG Oral Tablet	SCD	cb9d6493-374a-439a-b322-5c289e0f4109	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-779-30	43353077930	30 in 1 BOTTLE, PLASTIC	Historical
43353-779-53	43353077953	60 in 1 BOTTLE, PLASTIC	Historical
43353-779-60	43353077960	90 in 1 BOTTLE, PLASTIC	Historical
43353-779-70	43353077970	120 in 1 BOTTLE, PLASTIC	Historical
43353-779-80	43353077980	180 in 1 BOTTLE, PLASTIC	Historical
43353-779-90	43353077990	240 in 1 BOTTLE, PLASTIC	Historical
43353-779-92	43353077992	270 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg	Aphena Pharma Solutions - Tennessee, LLC	2014-05-07	HUMAN PRESCRIPTION DRUG LABEL	2