azithromycin monohydrate

Product NDC

68071-3168

11-digit product format

680713168

Labeler code

68071

Product ID

68071-3168_4ae01398-b1a3-2918-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azithromycin monohydrate

Dosage form

TABLET

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA065399

Marketing category

ANDA

Marketing start

2015-07-22

Marketing end

0000-00-00

Substance

AZITHROMYCIN MONOHYDRATE

Active strength

500 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