NDC 71205-171

Nitrofurantion

Nitrofurantion

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

Product ID71205-171_870f64ca-0256-4e3f-8c34-dc603ccc41c0
NDC71205-171
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion
Generic NameNitrofurantion
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA201722
Labeler NameProficient Rx LP
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71205-171-10

10 CAPSULE in 1 BOTTLE (71205-171-10)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-171-20 [71205017120]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 71205-171-10 [71205017110]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 71205-171-14 [71205017114]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:870f64ca-0256-4e3f-8c34-dc603ccc41c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759

    • 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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