MedPath

Ciprofloxacin

Ciproflaxin Tablets

Approved
Approval ID

6d8d72fe-e89c-4e08-9ca1-ec64c4890205

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 27, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

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 Code67296-0579
Application NumberANDA077859
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2011
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CIPROFLOXACINActive
Quantity: 500 mg in 1 1
Code: 5E8K9I0O4U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT

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Ciprofloxacin - FDA Drug Approval Details