NDC 68071-4428

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID68071-4428_6bccbaab-151c-4a04-e053-2991aa0ae105
NDC68071-4428
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (monohydrate/macrocrystals)
Generic NameNitrofurantoin (monohydrate/macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA077066
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameNITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active Ingredient Strength75 mg/1; mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-4428-2

2 CAPSULE in 1 BOTTLE (68071-4428-2)
Marketing Start Date2018-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4428-6 [68071442806]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-09
Inactivation Date2020-01-31
Reactivation Date2020-02-18

NDC 68071-4428-2 [68071442802]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-09
Inactivation Date2020-01-31
Reactivation Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:6bccbaab-151b-4a04-e053-2991aa0ae105
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Nitrofurantoin (monohydrate/macrocrystals)" or generic name "Nitrofurantoin (monohydrate/macrocrystals)"

    NDCBrand NameGeneric Name
    0185-0122Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    0480-3470Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    16714-439Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    21695-300Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    55700-822Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    59746-762NITROFURANTOIN (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    60760-194Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63187-995Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63629-1459Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63629-1748Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4367Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4428Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-5076Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68084-446Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68788-7092Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4531Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70518-1087Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70518-0799Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70934-129Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    71335-0863Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    42291-574Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50268-625Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    53002-7042Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    60760-478Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    65162-478Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    67296-1640Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70934-269Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    55700-794Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50090-4570Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50090-3737NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-3856NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    53002-7041NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    63629-7968NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
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