FDA.reportPublic FDA data

NDC 80425-0103-01 - Clindamycin HCL

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
80425-0103
Requested NDC
80425-0103-01
Package NDCs from labels
80425-0103-1, 80425-0103-01
Manufacturer
Advanced Rx 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
Clindamycin HCL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0103-1Clindamycin HCL30 in 1 BOTTLECAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0103CLINDAMYCIN HCL CAPSULE [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_b43dc396-17ef-a523-e053-2a95a90ac872.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0103-1EA - Each80425-0103474460b1-8261-4105-bf12-2d605f33fb5f12023-03-13

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 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.fa084aad-07fa-44d2-8d01-d32f40acd2f32026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.7f7fc73a-86e1-4d3e-8c83-1c74621e4af42026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEHAWAII REPACK, INC.c6703df0-b41d-439f-8e0d-d30b3039b3f82026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacy1dd9e6b0-bcf4-5bf4-e063-6394a90a10c22026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef52026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.fadc321a-2291-4268-936f-0743fdddbe7f2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsf9e6ed50-ad03-4a9e-8760-8733e04a058c2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.1dbd8448-c1e5-46df-8060-50ef823804452026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
ndc (product): 63304-693
rxcui: 284215
rxcui: 197518
spl id: 5497511e-22f2-c613-e063-6394a90ac56c
spl set id: 1dbd8448-c1e5-46df-8060-50ef82380445
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack47f76d99-2024-4531-a527-66c80deeeb372026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1f1b9230-b8ef-b0e4-e063-6394a90afc472026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEUnit Dose Solutions, Inc.535e7e17-d020-4aa6-e063-6294a90ae1142026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 197518
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEGolden State Medical Supply, Inc.a69260bb-31b5-4f77-e053-2995a90a37e12026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 197518
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepacke4d91d51-b92e-4d3e-8379-f9463f4505372026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd1aa1e91-4ac8-40d1-9fc4-963e1c9c32782026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDECoupler LLC509a9bc3-0901-0874-e063-6294a90a88162026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W

Reported adverse events (FAERS/openFDA)#

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