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 1 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	St. Mary's Medical Park Pharmacy	56090def-7caf-e916-e063-6294a90a6ac2	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Coupler LLC	5827d07b-a0a4-a543-e063-6294a90ad565	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	American Health Packaging	d842fe4e-fc46-4d70-9ca3-b47191672f96	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Medcore LLC	1a6b7327-fd42-4de0-bd0d-2dd478502d52	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3d4a2486-863e-4e9f-be3b-67882863e7d4	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6b9ed3a4-46d5-462e-ac93-6b959b314d77	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	adb49cb7-8900-44dc-add0-22e2cd8235ac	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	0deb5368-ffdc-40fc-a97c-ba89b7a97e50	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	52b20439-6bf4-435e-817a-c3b3fc70846a	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	REMEDYREPACK INC.	37767123-8b72-4e1f-b00d-ff3305e9923f	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Unit Dose Solutions, Inc.	561ae476-9e1f-038a-e063-6394a90aa5c7	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Granules Pharmaceuticals Inc.	6f0d3966-962d-fa7c-e053-2a91aa0a8e3c	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Bryant Ranch Prepack	65c460f6-6470-41ff-abb4-d9d54ecc52f7	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Unit Dose Solutions, Inc.	5539d4f6-1192-2770-e063-6394a90a1e50	2026-06-27	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9617e2b0-4255-4542-95ca-9ee1818ca450	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	8643032a-c491-4ae4-ac46-5e0c4c79dc5b	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	St. Mary's Medical Park Pharmacy	7d4dd78a-f902-6ff2-e053-2991aa0ac7d7	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	cfdc0d68-00ad-44d6-b932-819cc3d5d60e	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	b81a8e64-ae41-409b-94a6-b36cb50bc25d	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	HAWAII REPACK, INC.	c4744824-4c74-411d-aa8e-c63ee9d89913	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL

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