Application 085159

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085159-001	METHOCARBAMOL	500MG	TABLET / ORAL		Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085159-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A085159-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085159-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085159-001	AA	1	`ea99ee380514…`

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 8 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL TABLETS	Pharmasource Meds, LLC	f43a9389-c641-ce49-e053-2a95a90a537f	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	1880efb2-b97e-1e4d-e063-6294a90ab3e3	2024-05-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
ROBAXIN	METHOCARBAMOL	Hikma Pharmaceuticals USA Inc.	090a3d3d-92c3-4c30-a648-436461f81702	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
ROBAXIN	METHOCARBAMOL	Hikma Pharmaceuticals USA Inc.	a418c43a-afe8-4a19-a57a-95c8dbe3d3d8	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Medsource Pharmaceuticals	127583d4-7963-bd6d-e063-6294a90ab73e	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	1637e18d-d9f9-4171-99e6-4b866d821c87	2024-02-07	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	XLCare Pharmaceuticals Inc.	f8bfb5cb-b7d0-4e09-b6bd-97a51d82c991	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8cf27774-82ed-4ed1-a55d-41bf476745db	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Aurobindo Pharma Limited	f83dd093-ea53-44c1-a40d-682ebc494b62	2024-01-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	2c1f5949-d771-45c6-8d8a-5e1942c853dc	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	2023-10-17	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Eugia US LLC	e8e8da30-64cf-42ea-bf71-d085b0be8a09	2023-10-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d8e3f8dc-9751-419b-8601-d85c43415c82	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f1bce76f-4c3a-40d2-8107-afc0d3a6ba19	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	4003026f-ed9e-40ac-9e7e-5e28d32d7cb8	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	b415184c-1603-4a86-92d2-746f8d3d3f3c	2023-03-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	c40d5c1d-9bd8-44aa-85a4-e1a34e1d3673	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	10ae354f-94a4-4d4e-bccc-ea189726b7ce	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Proficient Rx LP	f6193255-0e83-4510-bc86-30c926ee8fd1	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol

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 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1290	Methocarbamol	Methocarbamol	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1290	Methocarbamol	Methocarbamol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1290	Methocarbamol	Methocarbamol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1292	Methocarbamol	Methocarbamol	West-Ward Pharmaceuticals Corp	ANDA	Current
10544-259	Methocarbamol	Methocarbamol	Blenheim Pharmacal, Inc.	ANDA	Current
21695-078	Methocarbamol	Methocarbamol	Rebel Distributors Corp.	ANDA	Current
33261-072	Methocarbamol	Methocarbamol	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-130	Methocarbamol	Methocarbamol	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-588	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-641	Methocarbamol	Methocarbamol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0170	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0170	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0171	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0171	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0172	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0172	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0176	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0177	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50090-0178	Methocarbamol	Methocarbamol	A-S Medication Solutions	ANDA	Current
50436-4026	Methocarbamol	Methocarbamol	Unit Dose Services	ANDA	Current
50436-4027	Methocarbamol	Methocarbamol	Unit Dose Services	ANDA	Current
50436-4027	Methocarbamol	Methocarbamol	Unit Dose Services	ANDA	Current
60429-190	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
60429-191	Methocarbamol	Methocarbamol	Golden State Medical Supply, Inc.	ANDA	Current
66336-080	Methocarbamol	Methocarbamol	Dispensing Solutions, Inc.	ANDA	Current
67046-466	Methocarbamol	Methocarbamol	Contract Pharmacy Services-PA	ANDA	Current
67544-662	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
67544-747	Methocarbamol	Methocarbamol	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
68071-4365	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4365	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4458	Methocarbamol	Methocarbamol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68387-340	Methocarbamol	Methocarbamol	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-342	Methocarbamol	Methocarbamol	Keltman Pharmaceuticals Inc.	ANDA	Current
70518-1058	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70518-1058	Methocarbamol	Methocarbamol	REMEDYREPACK INC.	ANDA	Current
70934-320	Methocarbamol	Methocarbamol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-320	Methocarbamol	Methocarbamol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-528	Methocarbamol	Methocarbamol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-097	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71205-097	Methocarbamol	Methocarbamol	Proficient Rx LP	ANDA	Current
71335-0771	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-0844	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current
71335-0844	Methocarbamol	Methocarbamol	Bryant Ranch Prepack	ANDA	Current