FDA.reportPublic FDA data

Application 011011

Type
NDA
Sponsor
AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004ROBAXINMETHOCARBAMOLTABLET;ORAL500MGYesNo
006ROBAXIN-750METHOCARBAMOLTABLET;ORAL750MGYesYes

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
N011011-004ROBAXINMETHOCARBAMOL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N011011-006ROBAXIN-750METHOCARBAMOL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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
2026-08-01 22:54:322026-06N011011-004ROBAXIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N011011-006ROBAXIN-750750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLAmerican Health Packagingd842fe4e-fc46-4d70-9ca3-b47191672f962026-07-30Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLMedcore LLC1a6b7327-fd42-4de0-bd0d-2dd478502d522026-07-29Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3d4a2486-863e-4e9f-be3b-67882863e7d42026-07-29Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6b9ed3a4-46d5-462e-ac93-6b959b314d772026-07-29Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.adb49cb7-8900-44dc-add0-22e2cd8235ac2026-07-29Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.0deb5368-ffdc-40fc-a97c-ba89b7a97e502026-07-21Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacy56090def-7caf-e916-e063-6294a90a6ac22026-07-07Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLUnit Dose Solutions, Inc.5539d4f6-1192-2770-e063-6394a90a1e502026-06-27Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9617e2b0-4255-4542-95ca-9ee1818ca4502026-06-26Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.8643032a-c491-4ae4-ac46-5e0c4c79dc5b2026-06-26Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLA-S Medication Solutionscfdc0d68-00ad-44d6-b932-819cc3d5d60e2026-06-26Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsb81a8e64-ae41-409b-94a6-b36cb50bc25d2026-06-26Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.c4744824-4c74-411d-aa8e-c63ee9d899132026-06-25Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsName fallback
generic name: METHOCARBAMOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52244-429RobaxinMethocarbamolEndo Pharmaceuticals, Inc.NDACurrent
52244-449RobaxinMethocarbamolEndo Pharmaceuticals, Inc.NDACurrent
52244-449RobaxinMethocarbamolEndo Pharmaceuticals Inc.NDACurrent
52244-449RobaxinMethocarbamolEndo Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63487SUPPL2020-06-12
57893SUPPL2019-03-05
11919SUPPL2003-05-16
248SUPPL2003-05-16
33034SUPPL2003-05-06
10756SUPPL2003-05-06