azithromycin

Product NDC
59762-2198
11-digit product format
597622198
Labeler code
59762
Product ID
59762-2198_86aefdeb-2e61-4763-8593-fce5f69f5564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050711
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-05-13
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2198-1EA - Each59762-219801f9dc44-d9dc-4e4d-9647-85188e89909f12019-06-19
59762-2198-3EA - Each59762-2198eb07147c-fc83-46ec-a6a8-cdc9d2250e6e12019-06-19
59762-2198-7EA - Each59762-2198bc049022-f13f-47a2-b907-ac7ba9d0788712019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2198AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]41Legacy NDC20250416_f5b6daad-b5a9-462d-8e10-db22a7af1c72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKcd01f37d-4392-4d2b-e053-2995a90a721f2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf4c5422c-356c-8fcf-e053-2995a90ae0d92
308460azithromycin 250 MG Oral TabletPSNcd01f37d-4392-4d2b-e053-2995a90a721f2
308460azithromycin 250 MG Oral TabletPSNf4c5422c-356c-8fcf-e053-2995a90ae0d92
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNcd01f37d-4392-4d2b-e053-2995a90a721f2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf4c5422c-356c-8fcf-e053-2995a90ae0d92
308460azithromycin 250 MG Oral TabletSCDcd01f37d-4392-4d2b-e053-2995a90a721f2
308460azithromycin 250 MG Oral TabletSCDf4c5422c-356c-8fcf-e053-2995a90ae0d92
749783azithromycin 250 MG Oral Tablet 6 Count PackSYcd01f37d-4392-4d2b-e053-2995a90a721f2
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf4c5422c-356c-8fcf-e053-2995a90ae0d92
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK2414dc57-e373-485a-bc8e-b86c2aeb1d381
308460azithromycin 250 MG Oral TabletPSN2414dc57-e373-485a-bc8e-b86c2aeb1d381
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN2414dc57-e373-485a-bc8e-b86c2aeb1d381
308460azithromycin 250 MG Oral TabletSCD2414dc57-e373-485a-bc8e-b86c2aeb1d381
749783azithromycin 250 MG Oral Tablet 6 Count PackSY2414dc57-e373-485a-bc8e-b86c2aeb1d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-2198-3597622198033 BLISTER PACK in 1 CARTON (59762-2198-3) > 6 TABLET, FILM COATED in 1 BLISTER PACK (59762-2198-1) 3 blister pack2019-05-130000-00-00NoNoCurrent
59762-2198-75976221980730 TABLET, FILM COATED in 1 BOTTLE (59762-2198-7) 2019-05-130000-00-00NoNoCurrent