FDA.reportPublic FDA data

NDC 80425-0315-02 - Chlorzoxazone

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
80425-0315
Requested NDC
80425-0315-02
Package NDCs from labels
80425-0315-1, 80425-0315-2, 80425-0315-3, 80425-0315-02
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
Chlorzoxazone - 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
80425-0315-1Chlorzoxazone30 in 1 BOTTLETABLET302
80425-0315-2Chlorzoxazone60 in 1 BOTTLETABLET602
80425-0315-3Chlorzoxazone90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0315CHLORZOXAZONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8ff7293-89b6-b6ee-e053-6394a90a7d39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0315-1EA - Each80425-0315469ccd9f-223a-4ac6-8a0c-4455ec4f30a912023-06-06
80425-0315-2EA - Each80425-031506126fb5-4e03-40a0-8f86-e334eda55a7912023-06-06
80425-0315-3EA - Each80425-0315d5d0d47b-4608-40f1-af96-a6c9b942a57712023-06-06

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorzoxazoneCHLORZOXAZONEPar Health USA, LLC7c5a835d-3754-4c25-a0e2-335b8eceb2d22026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1088936
rxcui: 1088934
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepack6c77ca6b-fda6-43ab-8179-3e0bde6aa65f2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEREMEDYREPACK INC.3f73a1d1-b3ee-4678-bc02-3258ec8121272026-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONEPD-Rx Pharmaceuticals, Inc.8650d342-92df-48d7-9f3d-cdd6f6f4c0e72025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEHappy Robin, LLC3f90c7bc-118f-4371-e063-6394a90a279a2025-10-08Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
chlorzoxazoneCHLORZOXAZONESolubiomixc3d40a90-6df8-4b44-bc61-d7655c52bacb2025-10-06Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONERising Pharma Holdings, Inc.e0d10d67-9716-450b-b8a9-4e157008864e2025-09-17Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC36c1eb43-8840-8d84-e063-6394a90addca2025-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 1088936
rxcui: 1088934
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEAdvanced Rx of Tennessee, LLC30c9b3ce-198d-0c16-e063-6394a90a857d2025-03-20Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONELifsa Drugs LLC0f222059-1ece-44f3-ae7f-d277e5bcaba42025-03-16Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONECamber Pharmaceuticals, Inc.e9bb9ebf-fceb-4da8-950a-c4b1fd5a84f12025-03-16Warnings, Adverse reactionsExact identifier
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEProficient Rx LP0a8ee5fa-f393-4568-81bd-269f9a4cecd62025-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEA-S Medication Solutionsd0210638-b828-4c05-9669-fd61ef9873172025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONEAdvanced Rx Pharmacy of Tennessee, LLCf8ff7293-89b6-b6ee-e053-6394a90a7d392024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA089853
ndc (package): 80425-0315-2
ndc (package): 80425-0315-1
ndc (package): 80425-0315-3
ndc (product): 80425-0315
ndc11 (package): 80425031502
rxcui: 197502
spl id: 2a9bf621-afbe-7627-e063-6294a90a77a9
spl set id: f8ff7293-89b6-b6ee-e053-6394a90a7d39
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONEBryant Ranch Prepack5e6889c9-a091-4622-0a00-ad0fc1830f782024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepackd7f09907-83b2-46cf-947d-fa38dcf886852024-09-09Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
ChlorzoxazoneCHLORZOXAZONEActavis Pharma, Inc.2f05e8e2-616f-475b-ac9f-c42e1a5dbe812024-08-25Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEBryant Ranch Prepack669afcc1-d587-4dc0-8f6e-99109bcfed362024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA089853
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONECintex Services, LLC13a1aa33-6971-da5a-e063-6394a90a9e122024-03-21Warnings, Adverse reactionsExact identifier
rxcui: 197502
unii: H0DE420U8G
CHLORZOXAZONECHLORZOXAZONEAurobindo Pharma Limited52d3aa2c-f88f-4de7-b5ae-df8a46e948792023-09-05Warnings, Adverse reactionsExact identifier
application number: ANDA089853
ndc (product): 59651-306
rxcui: 1088936
rxcui: 1088934
rxcui: 197502
spl id: 13956b60-a22d-4ee8-af95-460830ebfbc9
spl set id: 52d3aa2c-f88f-4de7-b5ae-df8a46e94879
unii: H0DE420U8G

Reported adverse events (FAERS/openFDA)#

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