NDC 63629-6777

Nitrofurantoin Monohydrate/ Macrocrystalline

Nitrofurantoin

Nitrofurantoin Monohydrate/ Macrocrystalline is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.

Product ID63629-6777_17c4cc91-9876-411a-a9df-7bf007066b08
NDC63629-6777
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Monohydrate/ Macrocrystalline
Generic NameNitrofurantoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-05-25
Marketing CategoryNDA / NDA
Application NumberNDA020064
Labeler NameBryant Ranch Prepack
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 63629-6777-1

14 CAPSULE in 1 BOTTLE (63629-6777-1)
Marketing Start Date2015-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-6777-3 [63629677703]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-08
Inactivation Date2020-01-31

NDC 63629-6777-2 [63629677702]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-08
Inactivation Date2020-01-31

NDC 63629-6777-4 [63629677704]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-08
Inactivation Date2020-01-31

NDC 63629-6777-5 [63629677705]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-08
Inactivation Date2020-01-31

NDC 63629-6777-1 [63629677701]

Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

OpenFDA Data

SPL SET ID:896fb3ae-dd2d-415b-9c8a-a5ea5df6456a
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"

    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
    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
    55700-532Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    60760-055Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    63629-6777Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    67296-0737Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ Macrocrystalline
    0115-2023NitrofurantoinNitrofurantoin
    0115-2024NitrofurantoinNitrofurantoin
    0472-1992NitrofurantoinNitrofurantoin
    0591-3684NitrofurantoinNitrofurantoin
    0591-3685NitrofurantoinNitrofurantoin
    0591-3686NitrofurantoinNitrofurantoin
    0615-1308NitrofurantoinNitrofurantoin
    0615-7655NitrofurantoinNitrofurantoin
    13811-719NitrofurantoinNitrofurantoin
    16571-740NitrofurantoinNitrofurantoin
    40032-450NitrofurantoinNitrofurantoin
    43386-450NitrofurantoinNitrofurantoin
    46708-389NITROFURANTOINNITROFURANTOIN
    46708-390NITROFURANTOINNITROFURANTOIN
    46708-391NITROFURANTOINNITROFURANTOIN
    51655-611NitrofurantoinNitrofurantoin
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