FDA.reportPublic FDA data

NDC 70518-3168-2 - Azithromycin Dihydrate

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
70518-3168
Requested NDC
70518-3168-2
Package NDCs from labels
70518-3168-2, 70518-3168-0, 70518-3168-1, 70518-3168-3, 70518-3168-4, 70518-3168-5
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin Dihydrate - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3168-0Azithromycin Dihydrate2 in 1 BOXTABLET, FILM COATED210
70518-3168-1Azithromycin Dihydrate2 in 1 BOTTLE, PLASTICTABLET, FILM COATED210
70518-3168-2Azithromycin Dihydrate1 in 1 POUCHTABLET, FILM COATED110
70518-3168-3Azithromycin Dihydrate30 in 1 BLISTER PACKTABLET, FILM COATED3010
70518-3168-4Azithromycin Dihydrate3 in 1 BOTTLE, PLASTICTABLET, FILM COATED310
70518-3168-5Azithromycin Dihydrate5 in 1 BOTTLE, PLASTICTABLET, FILM COATED510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3168AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 6 package rows20240927_c7ed6985-1d1d-48af-9df8-64b12821789e.zip

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 60 of 114 · 2,276 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsExact identifier
unii: G2M7P15E5P
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc34c1486-fa6c-485f-80b3-98e397b3dddb2025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS74c078ec-a371-4406-8d5e-a0baada3a1a62025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 ToffeeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASd1181543-07ab-4a51-8b55-afc1a98293f62025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc7be3a7e-f031-4ec0-b9dc-41c025cd00662025-10-22WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC41c0c262-21c3-b8e6-e063-6394a90a7c9c2025-10-22WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC4196e616-bdd8-9e88-e063-6394a90ac81d2025-10-20Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier
unii: G2M7P15E5P
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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