NDC 68071-3134

Nitrofurantion

Nitrofurantion

Nitrofurantion is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals Industries, Inc.. The primary component is Nitrofurantoin.

Product ID68071-3134_49a0df95-df86-36b1-e054-00144ff8d46c
NDC68071-3134
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion
Generic NameNitrofurantion
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA201722
Labeler NameNuCare Pharmaceuticals Industries, Inc.
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-3134-1

10 CAPSULE in 1 BOTTLE (68071-3134-1)
Marketing Start Date2017-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3134-2 [68071313402]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-8 [68071313408]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-3 [68071313403]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-7 [68071313407]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-6 [68071313406]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-1 [68071313401]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

NDC 68071-3134-4 [68071313404]

Nitrofurantion CAPSULE
Marketing CategoryANDA
Application NumberANDA201722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-28
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:49a0df95-df85-36b1-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.