FDA.reportPublic FDA data

NDC 80425-0004-01 - Cephalexin

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
80425-0004
Requested NDC
80425-0004-01
Package NDCs from labels
80425-0004-1, 80425-0004-2, 80425-0004-3, 80425-0004-4, 80425-0004-5, 80425-0004-6, 80425-0004-7, 80425-0004-01
Manufacturer
ADVANCED RX PHARMACY OF TENNESSEE, LLC
Effective date
2024-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cephalexin - ADVANCED RX PHARMACY OF TENNESSEE, LLCADVANCED RX PHARMACY OF TENNESSEE, LLC2024-03-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0004-1Cephalexin28 in 1 BOTTLECAPSULE285
80425-0004-2Cephalexin40 in 1 BOTTLECAPSULE405
80425-0004-3Cephalexin6 in 1 BOTTLECAPSULE65
80425-0004-4Cephalexin5 in 1 BOTTLECAPSULE55
80425-0004-5Cephalexin14 in 1 BOTTLECAPSULE145
80425-0004-6Cephalexin20 in 1 BOTTLECAPSULE205
80425-0004-7Cephalexin30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0004CEPHALEXIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 7 package rows20240314_af49507d-254f-296d-e053-2a95a90ad263.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0004-1EA - Each80425-0004568b0d95-e053-4078-9588-aae633aac1c812023-03-13
80425-0004-2EA - Each80425-000408cd35d1-2cad-40a7-91fb-fdb8337d9e6512023-03-13
80425-0004-3EA - Each80425-0004fbaf8b0f-38f5-4531-9f5b-26ccf9d8e76612024-06-10
80425-0004-4EA - Each80425-000449b4d903-13ce-40d3-89cf-31cd97d711e712024-04-05
80425-0004-5EA - Each80425-00041020912e-44d0-4ba7-bbbc-b3ce215a774812024-04-05
80425-0004-6EA - Each80425-000488fa8483-8c3b-4c86-bbfe-68a6da75564f12024-04-05
80425-0004-7EA - Each80425-00049246bd25-019c-471d-a5b0-e435a401b8e412024-04-05

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 8 · 149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack5f867aa3-ea64-4a14-a63b-979b8ff8d80c2025-11-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINAvPAK5975f293-8bb3-3242-aca7-d7d0c7e1bdc82025-10-30Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutions21392758-c033-4d4d-81c9-d10e132f95b72025-10-18Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutionsbff3912c-c39c-40c0-98d2-27c3d506c24d2025-10-18Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack8d7f247a-3b42-4823-96fb-5f5c1bd94d492025-08-29Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack1bfa8744-24ee-4c70-845c-c532b80844332025-07-29Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA065253
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA065253
unii: OBN7UDS42Y
OrapazCEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATEBrisk Pharmaceuticals2de0b332-58a3-0bb4-e063-6394a90a1a452025-02-11Exact identifier
rxcui: 309114
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsExact identifier
application number: ANDA065253
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINBryant Ranch Prepack12f78d76-ea13-440c-8dd0-5aec86277acf2025-01-24Warnings, Adverse reactionsExact identifier
application number: ANDA065253
unii: OBN7UDS42Y

Reported adverse events (FAERS/openFDA)#

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