NDC 53002-7040

Nitrofurantoin Monohydrate/ Macrocrystalline

Nitrofurantoin Monohydrate/macrocrystalline

Nitrofurantoin Monohydrate/ Macrocrystalline is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.

Product ID53002-7040_73d1c317-9e59-4c13-be62-2e99c9699472
NDC53002-7040
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Monohydrate/ Macrocrystalline
Generic NameNitrofurantoin Monohydrate/macrocrystalline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-05-25
Marketing CategoryNDA / NDA
Application NumberNDA020064
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameNITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active Ingredient Strength25 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 53002-7040-1

6 CAPSULE in 1 BOTTLE (53002-7040-1)
Marketing Start Date2017-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-7040-2 [53002704002]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7040-1 [53002704001]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7040-3 [53002704003]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7040-4 [53002704004]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

OpenFDA Data

SPL SET ID:d97f0977-89e0-4918-aceb-1bbc1e322748
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/ Macrocrystalline" or generic name "Nitrofurantoin Monohydrate/macrocrystalline"

    NDCBrand NameGeneric Name
    10544-086Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    33261-160Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    42254-064Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    50090-0865Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    50090-0866Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    50090-4429Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    50436-6590Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    53002-7040Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    55700-532Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    60760-055Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    63629-6777Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin
    67296-0737Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    68071-1909Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    68071-3163Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    68788-0518Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    70934-047Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    71335-0191Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    76413-165Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    52427-285MacrobidNitrofurantoin Monohydrate/Macrocrystalline
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