Application 090200

Type: ANDA
Sponsor: HETERO LABS LTD III

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 44.

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
A090200-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL	AA		2009-11-06
A090200-002	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL	AA		2009-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090200-001	AA
A090200-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	METHOCARBAMOL	750MG	TABLET / ORAL	AA	2009-11-06	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090200-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090200-002	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090200-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090200-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090200-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090200-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090200-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090200-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090200-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090200-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090200-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090200-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090200-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090200-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090200-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090200-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090200-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090200-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090200-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090200-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090200-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090200-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090200-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090200-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090200-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090200-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090200-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090200-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090200-002	AA	1	`4b0b4de00fa7…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	XLCare Pharmaceuticals Inc.	f8bfb5cb-b7d0-4e09-b6bd-97a51d82c991	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	2c1f5949-d771-45c6-8d8a-5e1942c853dc	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	10ae354f-94a4-4d4e-bccc-ea189726b7ce	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200
Methocarbamol	METHOCARBAMOL	Camber Pharmaceuticals, Inc.	43af0c41-9990-4902-9384-75de5ea08283	2021-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090200 application number: ANDA090200

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 · 133 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-1622	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-1622	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
63629-8097	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
65977-5033	Methocarbamol	Methocarbamol	Hetero Drugs Limited Unit III	ANDA	Current
65977-5034	Methocarbamol	Methocarbamol	Hetero Drugs Limited Unit III	ANDA	Current
66267-145	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-145	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-146	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-146	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-803	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-803	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
67046-467	Methocarbamol	Methocarbamol	Contract Pharmacy Services-PA	ANDA	Current
67296-0751	Methocarbamol	Methocarbamol	RedPharm Drug, Inc.	ANDA	Current
67296-0751	Methocarbamol	Methocarbamol	RedPharm Drug, Inc.	ANDA	Current
67296-1049	Methocarbamol	Methocarbamol	RedPharm Drug, Inc.	ANDA	Current
67296-1049	Methocarbamol	Methocarbamol	RedPharm Drug, Inc.	ANDA	Current
67296-1049	Methocarbamol	Methocarbamol	RedPharm Drug, Inc.	ANDA	Current
68084-056	Methocarbamol	Methocarbamol	American Health Packaging	ANDA	Current
68084-057	Methocarbamol	Methocarbamol	American Health Packaging	ANDA	Current
68788-6391	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6391	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6391	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6391	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9376	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9376	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9376	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9376	Methocarbamol	Methocarbamol	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0536	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-0536	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-0548	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-0548	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-0548	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1271	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1271	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1271	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1554	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1554	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1554	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1554	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1554	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70934-114	Methocarbamol	Methocarbamol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-114	Methocarbamol	Methocarbamol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0251	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-0251	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-0251	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
80175-0533	METHCARBAMOL	METHCARBAMOL	Central Packaging	ANDA	Current
80175-0533	METHCARBAMOL	METHCARBAMOL	Central Packaging	ANDA	Current
80175-0533	METHCARBAMOL	METHCARBAMOL	Central Packaging	ANDA	Current
80175-0533	METHCARBAMOL	METHCARBAMOL	Central Packaging	ANDA	Current
80175-0534	METHOCARBAMOL	METHOCARBAMOL	Central Packaging	ANDA	Current
80175-0534	METHOCARBAMOL	METHOCARBAMOL	Central Packaging	ANDA	Current
80175-0534	METHOCARBAMOL	METHOCARBAMOL	Central Packaging	ANDA	Current
80175-0534	METHOCARBAMOL	METHOCARBAMOL	Central Packaging	ANDA	Current