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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3e74e8a3-2670-97f5-e063-6394a90a361e2026-08-03Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3e796794-b731-61d6-e063-6394a90aa9b32026-07-31Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEMajor Pharamceuticalsfd86ff45-37d0-4501-b9fb-e1836e4a8be42026-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.caa99901-467c-4e99-b7e9-fbabdf5d118c2026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.0becbde8-6ec5-4830-a0d9-cfdb7b15eb842026-07-03Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack093ff3c7-3ecc-47b4-9ae6-5218bcd262b22026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack65767ae3-b1ed-4492-90f2-703b2c7e0f382026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.87a137c6-dd53-44d3-ab49-ef78ebed35c82026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ec20539-0421-4eac-95ed-e9acc6329fd02026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7e2390b7-242c-43ff-afb3-b0a5e79351d32026-05-13Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackc11bfea8-6079-44ce-b8e1-20bfba631bec2026-05-04Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6e0efd1a-5a09-4030-8fe2-f98334cdeb0e2026-04-22Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9c43389b-dc98-41f3-80bf-73d916ad68432026-04-22Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad2026-04-17Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
rxcui: 197985
unii: 0020414E5U
MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbae17358-1180-4ca8-b163-f9a6f4f83a3d2026-04-09Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited3539f84e-b489-4914-96c1-ac37310329712026-04-08Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited55df55fb-18ec-4e00-9ed0-10bba0da513b2026-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA065062
ndc (product): 13668-484
rxcui: 197984
rxcui: 314108
rxcui: 197985
spl id: 4ee4f6d7-55da-406d-9a32-de923b01c15c
spl set id: 55df55fb-18ec-4e00-9ed0-10bba0da513b
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack409dddb0-be3a-4ae3-ab39-88a6cd50a2192026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackb3236a5c-8a5d-4d5d-9656-aee72a4c482b2026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka16012ce-5754-4177-bfb7-dcce696a71892026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U

Reported adverse events (FAERS/openFDA)#

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