NDC 53002-7042

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 Rpk Pharmaceuticals, Inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID53002-7042_38c60396-7501-486e-9f95-2c896b085a7b
NDC53002-7042
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (monohydrate/macrocrystals)
Generic NameNitrofurantoin Monohydrate/macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA207372
Labeler NameRPK 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 53002-7042-1

6 CAPSULE in 1 BOTTLE (53002-7042-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-7042-2 [53002704202]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA207372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-7042-3 [53002704203]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA207372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-7042-1 [53002704201]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA207372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-7042-4 [53002704204]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA207372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:58614369-f5ac-4d38-9fb8-2383b791eb71
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)
    68071-4531Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4428Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68084-446Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68788-7092Nitrofurantoin (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)
    67296-1640Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70934-269Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-5076Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-3737NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-3856NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    53002-7041NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60687-633NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60760-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    63629-7968NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
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