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 6 of 8 · 149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINBryant Ranch Prepackf4ced8c7-a276-4a44-a60c-f8d1689a2bdf2024-07-26Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6e5f9616-ddf2-19c4-e053-2991aa0a372a2024-07-18Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ada33464-b416-9ac6-e053-2a95a90af7872024-07-17Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ade02343-3e4b-b1f1-e053-2995a90ac5fe2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.a33280d4-7caf-f74b-e053-2a95a90a90c32024-07-17Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINAsclemed USA, Inc945552cb-90e4-41fb-afe2-8ee8785e94da2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutions3fcb3f88-9dfc-444d-952a-1d19677205252024-06-28Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINAsclemed USA, Inc.4eb58a7e-1c92-4be3-b702-e522e0fbf4252024-06-21Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINAsclemed USA, Inc.20f8cc57-231c-4d36-a209-ff9e5735d65c2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.90a76d24-e5a9-9000-e053-2a95a90ae8af2024-06-19Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e2024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6be20569-df34-04d9-e053-2991aa0a94fd2024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.728c5212-dbd8-8df5-e053-2a91aa0a95792024-06-10Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.681c235f-6dee-1401-e053-2991aa0addc02024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutions73920373-b45d-45d6-b183-d962467dde362024-05-24Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutionsfc426d0d-9774-4189-8d83-89aa85d926bb2024-05-22Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutions712a6789-7aab-4114-ae92-d1c7686c6b962024-05-16Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
CephalexinCEPHALEXINA-S Medication Solutions5b7666f3-4014-45ce-8387-3298d9fe6d252024-05-07Warnings, Adverse reactionsExact identifier
rxcui: 309114
unii: OBN7UDS42Y
cephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.141bd050-5dfc-68fa-e063-6394a90a6d862024-03-20Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf49507d-254f-296d-e053-2a95a90ad2632024-03-12Warnings, Adverse reactionsExact identifier
application number: ANDA065253
ndc (package): 80425-0004-5
ndc (package): 80425-0004-4
ndc (package): 80425-0004-2
ndc (package): 80425-0004-1
ndc (package): 80425-0004-3
ndc (package): 80425-0004-6
ndc (package): 80425-0004-7
ndc (product): 80425-0004
ndc11 (package): 80425000401
rxcui: 309114
spl id: 137a5de3-ab83-e2ab-e063-6294a90a6209
spl set id: af49507d-254f-296d-e053-2a95a90ad263
unii: OBN7UDS42Y

Reported adverse events (FAERS/openFDA)#

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