MedPath

Ciprofloxacin

Ciprofloxacin Injection, USP

Approved
Approval ID

19df63de-9f44-40ce-9a4f-0c96345b8a23

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 16, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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

Ciprofloxacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-422
Application NumberANDA077782
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 22, 2010
FDA Product Classification

INGREDIENTS (3)

CiprofloxacinActive
Quantity: 10 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Lactic AcidInactive
Code: 33X04XA5AT
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Ciprofloxacin - FDA Drug Approval Details