Azithromycin

Product NDC
64679-962
11-digit product format
646790962
Labeler code
64679
Product ID
64679-962_d28cdf46-bf90-bbdf-e053-2a95a90a497e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA065302
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
64679-962-01EA - Each64679-9621479a635-917d-4afd-9fde-c5c1a807b7d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSNac66be47-babc-41eb-b259-03a7020cec231
204844azithromycin 600 MG Oral TabletSCDac66be47-babc-41eb-b259-03a7020cec231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-962-016467909620130 TABLET, FILM COATED in 1 BOTTLE (64679-962-01) 2015-07-280000-00-00NoNoCurrent
64679-962-03646790962031400 TABLET, FILM COATED in 1 POUCH (64679-962-03) 2015-07-280000-00-00NoNoCurrent