FDA.reportPublic FDA data

NDC 80425-0145-01 - 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
80425-0145
Requested NDC
80425-0145-01
Package NDCs from labels
80425-0145-1, 80425-0145-2, 80425-0145-3, 80425-0145-01
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
Clindamycin HCL - 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
80425-0145-1Clindamycin HCL30 in 1 BOTTLECAPSULE307
80425-0145-2Clindamycin HCL21 in 1 BOTTLECAPSULE217
80425-0145-3Clindamycin HCL28 in 1 BOTTLECAPSULE287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0145CLINDAMYCIN HCL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_c46cac0a-0c36-02fa-e053-2995a90a772b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0145-1EA - Each80425-01459c7783db-74da-42a3-a2ac-cb62f3f1972e12023-03-13
80425-0145-2EA - Each80425-014518b7476f-567b-497c-8f05-2e8653d2e7f412023-06-06
80425-0145-3EA - Each80425-0145bc0293fa-7e41-4b0b-a592-74cf7d1a158d12023-10-16

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 3 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXc3f35f80-e4ae-95f5-e053-2995a90a1b642025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEAmerican Health Packaging3f6b2c5a-e581-414f-bc9e-eaf66a5685cd2025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.12dea490-e179-f295-e063-6394a90af4aa2025-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBrisk Pharmaceuticals2de041be-1d36-ee95-e063-6294a90a20912025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
Clindamycin HCLCLINDAMYCIN HCLAdvanced Rx Pharmacy of Tennessee, LLCc46cac0a-0c36-02fa-e053-2995a90a772b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065442
ndc (package): 80425-0145-3
ndc (package): 80425-0145-1
ndc (package): 80425-0145-2
ndc (product): 80425-0145
ndc11 (package): 80425014501
rxcui: 284215
spl id: 2a999573-1034-813a-e063-6294a90a49b1
spl set id: c46cac0a-0c36-02fa-e053-2995a90a772b
unii: T20OQ1YN1W
Clindamycin HCLCLINDAMYCIN HCLAdvanced Rx of Tennessee, LLCb43dc396-17ef-a523-e053-2a95a90ac8722024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.2178249b-a9fe-5015-e063-6294a90a9ff42024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEQuality Care Products, LLC1d562ae9-5a9a-4fed-8cc7-3f30fb40f9572024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions7b110bab-815e-4654-860b-b9142fd93d452024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.2290109b-45c9-1aab-e063-6294a90a673b2024-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack2b13d66d-4f48-477e-ba32-20e85d0e708d2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack7537fbab-c792-4b77-8736-c24b69cf48ea2024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions8af1493c-1f22-4629-a432-f8b0578189e12024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA065442
unii: T20OQ1YN1W
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.11e8dd9c-81fd-4e88-e063-6294a90af13e2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackbea7de4c-c077-4535-96a0-f6b319120b0b2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b2bd8402-c887-5bfd-e053-2a95a90a15d92024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1d760cb7-d166-6707-e063-6394a90a88502024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e68cb17-73d9-8a00-e053-2995a90a517f2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 284215
unii: T20OQ1YN1W
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9fe44bdd-eb59-4b55-e053-2995a90a31832024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.678912ff-a0c1-171b-e053-2991aa0ad1282024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W

Reported adverse events (FAERS/openFDA)#

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