Azithromycin

Product NDC
50436-4357
11-digit product format
504364357
Labeler code
50436
Product ID
50436-4357_a6aa72f4-f6df-40e9-a446-f2801ac785c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065153
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4357-1Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4357-1EA - Each50436-43579e00298e-b8ea-429a-ba94-2325308311d812013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4357AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20170702_7c960f3a-829f-452f-8206-ff9a72c01468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK7c960f3a-829f-452f-8206-ff9a72c014686
308460azithromycin 250 MG Oral TabletPSN7c960f3a-829f-452f-8206-ff9a72c014686
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN7c960f3a-829f-452f-8206-ff9a72c014686
308460azithromycin 250 MG Oral TabletSCD7c960f3a-829f-452f-8206-ff9a72c014686
749783azithromycin 250 MG Oral Tablet 6 Count PackSY7c960f3a-829f-452f-8206-ff9a72c014686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4357-1504364357016 in 1 BLISTER PACKHistorical