Azithromycin

Manufacturing Establishments1

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

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

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

NDC Product Code

68071-2507

Application Number

ANDA210001

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

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