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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack99825095-d897-4077-86df-483d505615b22026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack493bdeac-e073-4ec2-a481-85e6a6d3cb582026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack74946a91-b138-42cd-a9d4-58fe8f8492702026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack653b22f3-9eb5-4c29-9b95-bc1c4f0273be2026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke1611d28-0c96-4ce2-ad5d-f62f66ec164d2026-03-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 197984
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC0760232b-21a6-2b13-e063-6394a90a22c12026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197984
unii: 0020414E5U
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLCf33fcfd2-b9ef-8e67-e053-2a95a90a03062026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197985
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAscend Laboratories, LLCa8f95207-b259-4f50-87f2-3652d92688902025-12-18Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6b2a7493-2e6c-4901-b697-17eb188cc8dd2025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
MinocinMINOCYCLINE HYDROCHLORIDEMelinta Therapeutics, LLCe415c323-8219-464b-9e3e-72c5a796cdaa2025-09-11Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke69284bc-0479-48d0-beb5-a26cfad6cd762025-08-25Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack2688e63a-09c7-4d73-a923-cf14fec7b1a42025-07-28Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackddd22f2c-050b-4776-912b-39b3e6202c752025-07-28Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAmerican Health Packaging94d941e3-d3d8-4414-bd5c-4a92848e738f2025-07-25Warnings, Adverse reactionsExact identifier
application number: ANDA065062
rxcui: 197984
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9f4139e4-d4ab-46ea-a3f1-f719ab57a55e2025-07-03Warnings, Adverse reactionsExact identifier
unii: 0020414E5U
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack084fb405-fcb9-4db9-8d95-5a9c1d89f3b62025-07-03Warnings, Adverse reactionsExact identifier
unii: 0020414E5U

Reported adverse events (FAERS/openFDA)#

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