FDA Product

Nitrofurantion

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Nitrofurantion

FDA Product Code

70518-3041

Regulatory Information

NDC Product Code

70518-3041

Application Number

ANDA201722

Marketing Category

C73584

Effective Date

March 11, 2024

Territorial Authority

USA

FDA Title

Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Quantity: 100 mg in 1 1

Code: 927AH8112L

Class Code: ACTIB

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

NITROFURANTOIN

Code: 927AH8112L

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