Application 040489

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	No	No
002	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	750MG	No	No

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…`

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 3 · 48 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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3096	Methocarbamol	methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-3117	Methocarbamol	methocarbamol	REMEDYREPACK INC.	ANDA	Current
70868-901	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
70868-901	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
70868-901	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
70868-901	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
70868-910	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
70868-910	Methocarbamol	methocarbamol	Key Therapeutics	ANDA	Current
72189-284	METHOCARBAMOL	METHOCARBAMOL	DirectRx	ANDA	Current
72189-284	METHOCARBAMOL	METHOCARBAMOL	DirectRx	ANDA	Current
72189-284	METHOCARBAMOL	METHOCARBAMOL	DirectRx	ANDA	Current
72275-351	Methocarbamol	Methocarbamol	Primary Pharmaceuticals, Inc	ANDA	Current
76420-258	Methocarbamol	methocarbamol	Asclemed USA, Inc.	ANDA	Current
80425-0021	Robaxin	Methocarbamol 750mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0021	Robaxin	Methocarbamol 750mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0021	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0021	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current