NDC 43063-582

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 Pd-rx Pharmaceuticals, Inc.. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.

Product ID43063-582_739227ca-8a05-8059-e053-2991aa0aec66
NDC43063-582
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 NamePD-Rx 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 Through2020-12-31

Packaging

NDC 43063-582-10

10 CAPSULE in 1 BOTTLE, PLASTIC (43063-582-10)
Marketing Start Date2020-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-582-10 [43063058210]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-10

NDC 43063-582-14 [43063058214]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-07

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

OpenFDA Data

SPL SET ID:dd1df1f2-cad6-4a16-9892-bf8400afdda8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755
    • UPC Code
  • 0343063582145

    • 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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