FDA.reportPublic FDA data

Application 040188

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOLCARISOPRODOLTABLET;ORAL350MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040188-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1997-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040188-001AA

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 22:54:322026-06A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040188-001AA1a50c72e98297…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 70518-2800
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 72189-310
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 50090-5955
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 50090-5953
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.4626a7a7-c433-4dab-8deb-e6e45de493a62025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 72789-182
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.9d251c26-c893-425a-b8ac-20c06e50e80c2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 72789-190
CarisoprodolCARISOPRODOLBryant Ranch Prepackf8aee817-c652-441e-b99a-8cbc4e6d06ef2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepack95e13b8c-3558-43f0-b888-90978db878fb2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 71335-9621
CarisoprodolCARISOPRODOLBryant Ranch Prepackacc7f959-55ac-4d9b-8ef4-4538378364e62025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 63629-2416
CarisoprodolCARISOPRODOLOxford Pharmaceuticals, LLC03c3455f-e217-4a7e-908f-609333dc35fc2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 69584-111
CarisoprodolCARISOPRODOLMedsource Pharmaceuticals125023cb-45c2-1685-e063-6394a90af0892024-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2484de44-b36a-421c-a4d9-64c2016947542023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLProficient Rx LPb04fbd67-9ac5-4043-87e9-c3804d1e5d0c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 71205-704
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2179f18b-df15-4bf6-a7c7-6d9960f49a422021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 71610-617

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5953CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
50090-5955CarisoprodolCarisoprodolA-S Medication SolutionsANDACurrent
55700-954CarisoprodolCarisoprodolQuality Care Products, LLCANDACurrent
55700-954CarisoprodolCarisoprodolQuality Care Products, LLCANDACurrent
63629-2416CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
63629-2416CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
69036-920VanadomCarisoprodolSallus Laboratories, LLCANDACurrent
69036-920VanadomCarisoprodolSallus Laboratories, LLCANDACurrent
69584-111CarisoprodolCarisoprodolOxford Pharmaceuticals, LLCANDACurrent
70518-2800CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-2800CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-2800CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
70518-2800CarisoprodolCarisoprodolREMEDYREPACK INC.ANDACurrent
71205-704CarisoprodolCarisoprodolProficient Rx LPANDACurrent
71335-9621CarisoprodolCarisoprodolBryant Ranch PrepackANDACurrent
71610-617CarisoprodolCarisoprodolAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-310CARISOPRODOLCARISOPRODOLDirectrxANDACurrent
72189-310CARISOPRODOLCARISOPRODOLDirectrxANDACurrent
72189-310CARISOPRODOLCARISOPRODOLDirectrxANDACurrent
72789-182CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-182CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-190CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-190CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-190CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-190CarisoprodolCarisoprodolPD-Rx Pharmaceuticals, Inc.ANDACurrent