Methocarbamol

Product NDC
53002-3590
Requested package NDC
53002-3590-2
11-digit product format
530023590
Labeler code
53002
Product ID
53002-3590_873ebcc4-1f3a-4262-a723-debb26ecc930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090200
Marketing category
ANDA
Marketing start
2013-03-20
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-359053002-3590-2IInactivated by FDA2026-08-03

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 1 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090200-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2009-11-06
A090200-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2009-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090200-001AA
A090200-002AA

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090200-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090200-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090200-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090200-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090200-002AA1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3590-2Methocarbamol20 in 1 BOTTLETABLET205
53002-3590-2Methocarbamol12 in 1 CASETABLET125
53002-3590-3Methocarbamol12 in 1 CASETABLET125
53002-3590-3Methocarbamol30 in 1 BOTTLETABLET305
53002-3590-4Methocarbamol12 in 1 CASETABLET125
53002-3590-4Methocarbamol40 in 1 BOTTLETABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3590METHOCARBAMOL TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 6 package rows20230609_26a25c66-3dc4-4cfa-bd9f-ef3fa068364a.zip

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAmerican Health Packagingd842fe4e-fc46-4d70-9ca3-b47191672f962026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLUnit Dose Solutions, Inc.5539d4f6-1192-2770-e063-6394a90a1e502026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAvPAKbe37bc85-6a41-00d8-e053-2a95a90ae5042026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCf31ccb09-7a9a-60af-e053-2995a90a6e972026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCdf63611f-90e4-6bbe-e053-2a95a90a2aad2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC05b287d3-5004-4d8b-9ebe-a96caa2b8d892025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9aed8304-fa4e-49d6-bd81-fcb3e4cc61732025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff55df39-e314-4120-8fab-3757cbe5a8722025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions069045f1-d699-41d0-b674-cdb71cd5fbd02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.eed9ebd1-c243-4e82-bf4e-5fec370e722e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCoupler LLC2cee3893-70b7-6c2c-e063-6394a90aa79a2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf4e98f9f-b20b-8608-e053-2a95a90aa6b02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLXLCare Pharmaceuticals Inc.f8bfb5cb-b7d0-4e09-b6bd-97a51d82c9912024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN26a25c66-3dc4-4cfa-bd9f-ef3fa068364a5
197944methocarbamol 750 MG Oral TabletSCD26a25c66-3dc4-4cfa-bd9f-ef3fa068364a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3590-25300235900212 BOTTLE in 1 CASE (53002-3590-2) > 20 TABLET in 1 BOTTLE12 bottle2017-10-010000-00-00NoNoCurrent