NDC 70518-4160-01 - 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
70518-4160
Requested NDC
70518-4160-01
Package NDCs from labels
70518-4160-0, 70518-4160-1, 70518-4160-2, 70518-4160-3, 70518-4160-4, 70518-4160-5, 70518-4160-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-28
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.2026-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4160-0Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED66
70518-4160-1Azithromycin Dihydrate30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-4160-2Azithromycin Dihydrate6 in 1 BOTTLE, PLASTICTABLET, FILM COATED66
70518-4160-3Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED16
70518-4160-3Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED66
70518-4160-4Azithromycin Dihydrate2 in 1 BOTTLE, PLASTICTABLET, FILM COATED26
70518-4160-5Azithromycin Dihydrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4160AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 7 package rows20241030_f0cfda1a-910f-4764-8658-263037df5ea8.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 13 of 116 · 2,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
application number: ANDA208250
ndc (product): 68094-900
rxcui: 308460
rxcui: 749783
spl id: 1200c2bd-75cb-4855-b24b-b5627726ac2d
spl set id: d9b66736-3f1a-4d6d-bdc4-274f5adfb40c
unii: 5FD1131I7S
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
unii: G2M7P15E5P
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 308460
unii: 5FD1131I7S
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: 532B59J990
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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