FDA.reportPublic FDA data

Application 040489

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL500MGNoNo
002METHOCARBAMOLMETHOCARBAMOLTABLET;ORAL750MGNoNo

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
A040489-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2003-01-29
A040489-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2003-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040489-001AA
A040489-002AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29a50c72e98297…
2026-08-01 22:54:322026-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040489-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040489-002AA1a50c72e98297…

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 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3d4a2486-863e-4e9f-be3b-67882863e7d42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6b9ed3a4-46d5-462e-ac93-6b959b314d772026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.adb49cb7-8900-44dc-add0-22e2cd8235ac2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.0deb5368-ffdc-40fc-a97c-ba89b7a97e502026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9617e2b0-4255-4542-95ca-9ee1818ca4502026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.8643032a-c491-4ae4-ac46-5e0c4c79dc5b2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionscfdc0d68-00ad-44d6-b932-819cc3d5d60e2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsb81a8e64-ae41-409b-94a6-b36cb50bc25d2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.c4744824-4c74-411d-aa8e-c63ee9d899132026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacyfd8cac57-9664-1fa0-e053-6294a90af8722026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6466438c-4609-4554-8919-35710a1b556d2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack33f89a57-f65d-4e99-a3a3-690ef805d8692026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6af87b4e-6507-4190-b043-a6d3b440314a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-3096MethocarbamolmethocarbamolREMEDYREPACK INC.ANDACurrent
70518-3117MethocarbamolmethocarbamolREMEDYREPACK INC.ANDACurrent
70868-901MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
70868-901MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
70868-901MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
70868-901MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
70868-910MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
70868-910MethocarbamolmethocarbamolKey TherapeuticsANDACurrent
72189-284METHOCARBAMOLMETHOCARBAMOLDirectRxANDACurrent
72189-284METHOCARBAMOLMETHOCARBAMOLDirectRxANDACurrent
72189-284METHOCARBAMOLMETHOCARBAMOLDirectRxANDACurrent
72275-351MethocarbamolMethocarbamolPrimary Pharmaceuticals, IncANDACurrent
76420-258MethocarbamolmethocarbamolAsclemed USA, Inc.ANDACurrent
80425-0021RobaxinMethocarbamol 750mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0021RobaxinMethocarbamol 750mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0021MethocarbamolMethocarbamolAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0021MethocarbamolMethocarbamolAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent