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FDA Product

Nitrofurantoin

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

Basic Information

Nitrofurantoin

60687-483

Regulatory Information

60687-483

ANDA201722

C73584

September 5, 2023

USA

Nitrofurantoin Capsules, USP (Macrocrystals) 8447201/0619 Rx only

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

929561009

Active Ingredients

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

NITROFURANTOIN

Quantity: 100 mg in 1 1

Code: 927AH8112L

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Active Moieties

NITROFURANTOIN

Code: 927AH8112L

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