FDA.reportPublic FDA data

NDC 60505-2582-2 - 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
60505-2582
Requested NDC
60505-2582-2
Package NDCs from labels
60505-2582-2
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2019-06-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin Dihydrate - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2019-06-06HUMAN PRESCRIPTION DRUG LABEL
Azithromycin Dihydrate - A-S Medication SolutionsA-S Medication Solutions2018-06-18HUMAN PRESCRIPTION DRUG LABEL
Azithromycin Dihydrate - Unit Dose ServicesUnit Dose Services2018-05-15HUMAN PRESCRIPTION DRUG LABEL
Azithromycin Dihydrate - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2018-01-09HUMAN PRESCRIPTION DRUG LABEL
Azithromycin Dihydrate - Cambridge Therapeutics Technologies, LLCCambridge Therapeutics Technologies, LLC2017-01-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2582-0EA - Each60505-25825bd94dc3-96b6-4c01-adb3-f63b8a085e9312012-07-24
60505-2582-2EA - Each60505-2582992aaa45-1b1a-4028-b335-94b2fe70059412012-07-24
60505-2582-3EA - Each60505-2582d38c881f-3367-45f2-96ee-3347c8aced1612012-07-24
60505-2582-5EA - Each60505-2582edfa7e98-a3e9-4b35-ae25-da288cf9456c12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3

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 2 of 109 · 2,174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
AzithromycinAZITHROMYCINZydus Pharmaceuticals USA Inc.99e5bd22-a721-4e2e-a46c-d61a53c25c3d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
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
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 248656
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
AzithromycinAZITHROMYCINSandoz Inc34b70c23-92a6-460f-8dbb-15a0e6b9d3a92026-07-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 308460
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 308460
rxcui: 248656
rxcui: 749783
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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