FDA.reportPublic FDA data

NDC 70518-3254-05 - Azithromycin

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
70518-3254
Requested NDC
70518-3254-05
Package NDCs from labels
70518-3254-0, 70518-3254-1, 70518-3254-3, 70518-3254-2, 70518-3254-4, 70518-3254-5, 70518-3254-05
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3254-0Azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-3254-1Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED214
70518-3254-2Azithromycin2 in 1 BOXTABLET, FILM COATED214
70518-3254-3Azithromycin1 in 1 POUCHTABLET, FILM COATED114
70518-3254-4Azithromycin3 in 1 BOTTLE, PLASTICTABLET, FILM COATED314
70518-3254-5Azithromycin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3254AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 6 package rows20250315_614cc2a4-3fc7-455d-9e8a-212c496f0fbf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3254-0EA - Each70518-3254d9d410e6-1168-4c36-919c-6b74e50d80b812026-02-05
70518-3254-1EA - Each70518-3254c8cbf5ef-506a-4845-b4d1-1092810414a212026-02-05
70518-3254-2EA - Each70518-3254f6512e24-2368-44d0-8e1c-afa74882300012026-02-05
70518-3254-3EA - Each70518-3254dd475b86-7b02-4f39-86ad-5af9522d1c6d12026-02-05

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 1 of 111 · 2,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsExact identifier
application number: ANDA211792
ndc (package): 70518-3254-2
ndc (package): 70518-3254-0
ndc (package): 70518-3254-3
ndc (package): 70518-3254-5
ndc (package): 70518-3254-4
ndc (package): 70518-3254-1
ndc (product): 70518-3254
ndc11 (package): 70518325405
rxcui: 248656
spl id: 584fd2ea-a23d-8dfe-e063-6394a90a13f7
spl set id: 614cc2a4-3fc7-455d-9e8a-212c496f0fbf
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-08-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINREMEDYREPACK INC.5f144e92-c9eb-420a-9bb8-4265a9f20a982026-07-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Inc3b631aa1-2d46-40bc-a614-d698301ea4f92026-07-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions3b7e16b1-9a3c-4e3a-8411-841a708afe452026-07-23Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP