Azithromycin

Product NDC
66116-418
11-digit product format
661160418
Labeler code
66116
Product ID
66116-418_1e505c90-79e4-4267-83c4-2fbb93d75cc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA065153
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-418-062019-11-13C16284748780-197449f38-d21d-f6ea-e053-dbdaa90aa703AZITHROMYCIN TABLETS USP, 250 mg and 500 mg 7146 7169 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-418-06Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED61

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-418AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111213_1e505c90-79e4-4267-83c4-2fbb93d75cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletPSN1e505c90-79e4-4267-83c4-2fbb93d75cc61
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN1e505c90-79e4-4267-83c4-2fbb93d75cc61
308460azithromycin 250 MG Oral TabletSCD1e505c90-79e4-4267-83c4-2fbb93d75cc61
749783azithromycin 250 MG Oral Tablet 6 Count PackSY1e505c90-79e4-4267-83c4-2fbb93d75cc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-418-06661160418066 in 1 BLISTER PACKHistorical