NDC 61919-024

NITROFURANTION

Nitrofurantion

NITROFURANTION is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Nitrofurantoin.

Product ID61919-024_486fc2c3-8162-1e58-e054-00144ff88e88
NDC61919-024
Product TypeHuman Prescription Drug
Proprietary NameNITROFURANTION
Generic NameNitrofurantion
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA201722
Labeler NameDIRECT RX
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-024-28

28 CAPSULE in 1 BOTTLE (61919-024-28)
Marketing Start Date2017-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-024-28 [61919002428]

NITROFURANTION CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-13

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN50 mg/1

OpenFDA Data

SPL SET ID:486fc2c3-8161-1e58-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311995

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

    NDC Crossover Matching brand name "NITROFURANTION" or generic name "Nitrofurantion"

    NDCBrand NameGeneric Name
    50090-5693NitrofurantionNitrofurantion
    55700-893NitrofurantionNitrofurantion
    57664-231NitrofurantionNitrofurantion
    57664-232NitrofurantionNitrofurantion
    57664-233NitrofurantionNitrofurantion
    61919-024NITROFURANTIONNITROFURANTION
    68001-384NitrofurantionNitrofurantion
    68001-385NitrofurantionNitrofurantion
    68001-386NitrofurantionNitrofurantion
    68071-2363NitrofurantionNitrofurantion
    68071-2647NitrofurantionNitrofurantion
    68071-3134NitrofurantionNitrofurantion
    70518-3041NitrofurantionNitrofurantion
    70934-413NitrofurantionNitrofurantion
    71205-171NitrofurantionNitrofurantion
    71335-0024NitrofurantionNitrofurantion
    71335-0793NitrofurantionNitrofurantion
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