Application 208507

Type: ANDA
Sponsor: BEXIMCO PHARMS USA

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
A208507-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2017-07-21
A208507-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208507-001	AA
A208507-002	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	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208507-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2017-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208507-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2017-07-21	`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	A208507-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208507-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208507-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208507-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208507-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208507-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208507-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208507-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208507-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208507-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208507-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208507-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208507-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208507-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208507-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208507-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208507-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208507-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208507-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208507-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208507-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208507-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208507-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208507-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208507-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208507-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208507-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208507-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208507-002	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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3212f121-9428-4186-8f00-accf08bca473	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	288a3bcd-a2c8-4a9b-9602-59c0493b4a8d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3b0e60a7-3cff-4665-a473-ad3257619cdd	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 72789-022
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	943fe701-5d7d-4abe-a529-c5a548e94bc6	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	440bf1ba-a704-4c35-bece-0a0987fc0c11	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 72789-041
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	12c8da39-3a0e-4303-9655-29dd83507837	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 72789-110
Methocarbamol	METHOCARBAMOL	UNICHEM PHARMACEUTICALS (USA), INC.	5777cbb0-b5fd-4b36-ac1d-bc105fe96888	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 76385-124 ndc (product): 76385-123
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	ff572473-90e3-4f3b-a40e-8b97b86d327b	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9357672f-5d4d-40f5-a304-e0c34e174dc3	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c06c4a63-491c-baa2-e053-2a95a90a09ff	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 80425-0138
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c9600cc9-7e27-6e19-e053-2995a90ab024	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 80425-0171
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	c40d5c1d-9bd8-44aa-85a4-e1a34e1d3673	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507 ndc (product): 76420-040
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	201205d1-22f2-46bb-b298-02d4978ba568	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	39b4362e-a26e-49cb-9d06-898bc9b0e005	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	d825e4d6-8b00-473a-a6e6-90f5c3ad5bec	2018-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208507 application number: ANDA208507

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 · 107 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72789-022	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-022	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-022	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-041	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-110	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-110	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-110	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76385-123	Methocarbamol	Methocarbamol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-123	Methocarbamol	Methocarbamol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-124	Methocarbamol	Methocarbamol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-124	Methocarbamol	Methocarbamol	Bayshore Pharmaceuticals LLC	ANDA	Current
76420-040	Methocarbamol	Methocarbamol	Asclemed USA, Inc.	ANDA	Current
76420-040	Methocarbamol	Methocarbamol	Asclemed USA, Inc.	ANDA	Current
80425-0138	Robaxin	Methocarbamol 500mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0138	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0138	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0171	Robaxin	Methocarbamol 750mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0171	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0171	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0171	Methocarbamol	Methocarbamol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current