FDA.reportPublic FDA data

NDC 80425-0291-02 - Carisoprodol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0291
Requested NDC
80425-0291-02
Package NDCs from labels
80425-0291-1, 80425-0291-2, 80425-0291-3, 80425-0291-02
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carisoprodol - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0291-1Carisoprodol30 in 1 BOTTLETABLET302
80425-0291-2Carisoprodol60 in 1 BOTTLETABLET602
80425-0291-3Carisoprodol90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0291CARISOPRODOL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f835e66e-f3f3-c3cf-e053-6294a90addf2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0291-1EA - Each80425-029176526813-f053-4983-b076-62adff12a47f12023-06-06
80425-0291-2EA - Each80425-02913331c05f-521a-481e-8cdb-6b5daf70a45a12023-06-06
80425-0291-3EA - Each80425-029144797d90-e08b-49f9-aa4f-729c33f84f5412023-06-06

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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLNorthwind Health Company, LLC26e466be-8066-e562-e063-6394a90a9f812026-06-22Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLSt. Mary's Medical Park Pharmacy94f74800-1f0d-7814-e053-2a95a90a4f632026-06-17Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack269644bf-d32c-48a3-b3eb-1221150ebd222026-06-16Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLREMEDYREPACK INC.eebb9409-e333-4b9f-8059-6588c35ab5782026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack59f6f0e3-fdbd-4788-9944-37edde4b9a3c2026-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepacka3f1343f-1337-4b99-b1ae-4189324ec2e92026-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack93f909ea-2d2e-4a10-be50-7f33f3e904d42026-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLWestminster Pharmaceuticals, LLCbfb31551-8c57-4360-be3a-f6fbe84a891e2026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLScieGen Pharmaceuticals, Inc.069ea892-21a6-4703-8dd3-bf19c44064792026-02-27Warnings, Adverse reactionsExact identifier
application number: ANDA203374
ndc (product): 50228-109
rxcui: 197446
spl id: 60f38a99-69ef-4d7e-80b0-555575993116
spl set id: 069ea892-21a6-4703-8dd3-bf19c4406479
unii: 21925K482H
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLDirect_Rx8e9bb49a-8cc3-4390-e053-2a95a90a4e0e2026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLChartwell RX, LLCa44a3dfc-a427-4584-a086-4bc0c538b1252025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack35a8e0a4-93a3-44e3-903f-4661ee1cffe82025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack409b04af-b9fd-4ba5-afa0-3e43466f8d2d2025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLPD-Rx Pharmaceuticals, Inc.1f08f4af-37c2-49b5-a4e3-284414f866fa2025-10-23Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
SomaCARISOPRODOLViatris Specialty LLC6297cf20-830a-11dc-94c8-0002a5d5c51b2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLBryant Ranch Prepack8c0c418c-90e2-4b81-a9c0-b131c38ec8742025-07-28Warnings, Adverse reactionsExact identifier
unii: 21925K482H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.