Azithromycin Dihydrate

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

RPK Pharmaceuticals, Inc.

DUNS Number

147096275

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

53002-2221

Application Number

ANDA065509

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 2017

Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive

Code: RFW2ET671PClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Code: 5FD1131I7SClass: ACTIMQuantity: 500 mg in 1 1

TRIACETINInactive

Code: XHX3C3X673Class: IACT