FDA.reportPublic FDA data

NDC 80425-0314-01 - Minocycline hydrochloride

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
80425-0314
Requested NDC
80425-0314-01
Package NDCs from labels
80425-0314-1, 80425-0314-2, 80425-0314-3, 80425-0314-01
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
Minocycline hydrochloride - 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
80425-0314-1Minocycline hydrochloride30 in 1 BOTTLECAPSULE302
80425-0314-2Minocycline hydrochloride60 in 1 BOTTLECAPSULE602
80425-0314-3Minocycline hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0314MINOCYCLINE HYDROCHLORIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f901a1ba-1716-8795-e053-6294a90a4e77.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0314-1EA - Each80425-0314653d204f-3fba-4924-b79e-2cd154f86e4c12023-06-06
80425-0314-2EA - Each80425-0314bf184420-b29b-4035-bf5b-6dbf3159970012023-06-06
80425-0314-3EA - Each80425-031414b81cd7-f3d4-4a6a-9de3-430059c885a512023-06-06

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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.abaacdeb-2433-261a-e053-2995a90ae34e2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
ArestinMINOCYCLINE HYDROCHLORIDEOraPharma, Inc.8515df41-1936-4f3b-86ba-d2bb2a8441fb2024-05-31Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC192327c5-d2bc-1bd1-e063-6394a90a110b2024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
ZILXIMINOCYCLINEJourney Medical Corporationcbffa96e-2446-43cf-ba5e-38c645302afd2024-02-09Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDELupin Pharmaceuticals, Inc.3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b2023-10-30Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
AMZEEQMINOCYCLINEJourney Medical Corporationcc251492-977b-4eb1-a088-a90831324bad2023-10-01Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutions1229c84c-5627-4992-bb8a-7874b215c5432023-09-17Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LP4f904969-5af3-461e-b557-d03a1e5c72922023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPd5fcba91-6aa6-4072-aea5-fb8da65d9aac2022-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LP49e65b60-ffc9-4ccd-9aec-29a462358d272022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEStrides Pharma Science Limitedd6e136ba-c9b1-4846-ae2a-98a29cb4504d2022-03-31Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPe6b04358-0f4c-4b21-a7f3-320d1e7bc0b82021-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPd67e4b17-7d44-4d72-9150-420d98cc6db32019-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka84c29a9-21a8-4965-b5a5-37b28e4af5a02019-06-13Warnings, Adverse reactionsExact identifier
rxcui: 197984
rxcui: 197985
unii: 0020414E5U

Reported adverse events (FAERS/openFDA)#

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