NDC 68001-384

Nitrofurantion

Nitrofurantion

Nitrofurantion is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Labortories. The primary component is Nitrofurantoin.

Product ID68001-384_ad020393-1c97-49da-b0f3-d6a9359fb73d
NDC68001-384
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion
Generic NameNitrofurantion
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA201722
Labeler NameBluePoint Labortories
Substance NameNITROFURANTOIN
Active Ingredient Strength25 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-384-00

100 CAPSULE in 1 BOTTLE (68001-384-00)
Marketing Start Date2019-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-384-00 [68001038400]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-14

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

OpenFDA Data

SPL SET ID:ad020393-1c97-49da-b0f3-d6a9359fb73d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759
  • 311995
  • 311994
    • UPC Code
  • 0368001385008
  • 0368001386005

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]
    • 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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