NDC 80425-0291-01 - 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
80425-0291-01
Package NDCs from labels
80425-0291-1, 80425-0291-2, 80425-0291-3, 80425-0291-01
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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLMylan Pharmaceuticals Inc.7c9184c0-7a2e-11df-8c8d-0002a5d5c51b2025-07-15Warnings, Adverse reactionsExact identifier
unii: 21925K482H
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLGranulation Technology, Inc.2abd11e4-8ce4-4aeb-87c4-3af94c1977142025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.4626a7a7-c433-4dab-8deb-e6e45de493a62025-02-05Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.9d251c26-c893-425a-b8ac-20c06e50e80c2025-02-05Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLNuCare Pharmaceuticals,Inc.fd03c357-b199-c2b2-e053-6294a90abe2e2025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLBryant Ranch Prepackf8aee817-c652-441e-b99a-8cbc4e6d06ef2025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLBryant Ranch Prepack95e13b8c-3558-43f0-b888-90978db878fb2025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLBryant Ranch Prepackacc7f959-55ac-4d9b-8ef4-4538378364e62025-01-24Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLDirect_Rxead8294f-fd27-5c3d-e053-2a95a90a64af2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLAdvanced Rx Pharmacy of Tennessee, LLCf835e66e-f3f3-c3cf-e053-6294a90addf22024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA203374
ndc (package): 80425-0291-1
ndc (package): 80425-0291-3
ndc (package): 80425-0291-2
ndc (product): 80425-0291
ndc11 (package): 80425029101
rxcui: 197446
spl id: 2a9bf7d3-46d8-0dfa-e063-6394a90a76a4
spl set id: f835e66e-f3f3-c3cf-e053-6294a90addf2
unii: 21925K482H
CarisoprodolCARISOPRODOLOxford Pharmaceuticals, LLC03c3455f-e217-4a7e-908f-609333dc35fc2024-12-24Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLWilshire Pharmaceuticals, Inc.f03a1ea6-20c1-406a-a5b6-00f1a056d9ff2024-12-13Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLAsclemed USA, Inc.301f5e6a-54e1-4885-b9cb-de475de59b222024-09-12Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CARISOPRODOLCARISOPRODOLBryant Ranch Prepackfdd6318f-399f-499c-acdc-5318aa080f362024-08-29Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLBryant Ranch Prepackb72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c2024-08-29Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLBryant Ranch Prepack8079db44-70d4-4daf-b4b7-89d0e0f384702024-08-14Warnings, Adverse reactionsExact identifier
unii: 21925K482H
CARISOPRODOLCARISOPRODOLNuCare Pharmaceuticals,Inc.93cbe188-5443-b392-e053-2995a90a9ac72024-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA203374
rxcui: 197446
unii: 21925K482H
CarisoprodolCARISOPRODOLMedsource Pharmaceuticals125023cb-45c2-1685-e063-6394a90af0892024-02-26Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLAurobindo Pharma Limited79637c7b-fe7b-436c-892b-6c36abfdcacc2024-01-06Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H
carisoprodolCARISOPRODOLRising Pharma Holdings, Inc.4d2470cb-7a5d-45f0-b005-534458833d912024-01-06Warnings, Adverse reactionsExact identifier
rxcui: 197446
unii: 21925K482H

Reported adverse events (FAERS/openFDA)#

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