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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.63f26644-b7ab-98c1-e053-2a91aa0af5d32024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions2393251d-33b9-4274-9d04-27ec9968eaa12024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEChartwell RX, LLCe8167412-882e-4143-93c6-49e68adbcf162024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAvPAKb2a810f1-c009-e973-e053-2a95a90ad5b02024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions337870c6-11e0-4d1a-a26e-afe042ee08c32024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
unii: T20OQ1YN1W
clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLCe08eea9e-464c-429e-9584-b768f51277672023-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions600c5ac7-64f7-44ac-9e83-cc1036471eec2023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions22bf9385-cad3-43a7-802f-131b6826b5a52023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEAsclemed USA, Inc.cd5a1db8-9ddf-4de3-b856-bc3e8fb290612023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions07f5d841-9c58-4dd1-b0bc-e12553931c8e2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions18ef4551-4066-4765-90cb-285d7711cf612023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEProficient Rx LPf7e51a42-bc9e-490f-b8d8-8765f0b5be462022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LP158e6c0c-1ca3-49a6-84fd-54d8fde7c2a72022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065061
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac32022-04-01Boxed 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.