Methocarbamol

Product NDC
43063-588
11-digit product format
430630588
Labeler code
43063
Product ID
43063-588_7d4efb95-f335-3a91-e053-2991aa0aa55d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA085159
Marketing category
ANDA
Marketing start
2000-01-01
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-588DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-10DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-14DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-15DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-20DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-30DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-40DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-60DDiscontinued by firm2026-08-10
excluded packagepackage43063-58843063-588-90DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 108 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-588-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-588-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-588-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-588-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-588-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-588-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-588-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-588-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-588-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-588-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-588-40302b2466d912…e7b80fea0513…

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085159-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085159-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A085159-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085159-001AA1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-588-10EA - Each43063-588c1ec77d2-a0e8-486e-9ffc-24c8ddb90c7e12017-03-06
43063-588-14EA - Each43063-58878d38869-de03-49b7-9810-526c218ca65412016-06-14
43063-588-15EA - Each43063-5884b1f751a-1c12-44be-8f9a-11553797268412016-04-04
43063-588-20EA - Each43063-5881900dac1-9b13-4397-9fd4-19c2393a164b12016-01-13
43063-588-30EA - Each43063-588fe24f263-bc78-4a5a-8a6f-93b586da153d12015-09-10
43063-588-40EA - Each43063-588eab57291-13da-4ae4-be31-1b64e35d3ea012016-01-13
43063-588-90EA - Each43063-58831593ee0-1b21-4295-bc54-ed1843cc88a212017-03-06