NDC 52427-285

Macrobid

Nitrofurantoin Monohydrate/macrocrystalline

Macrobid is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Almatica Pharma Inc.. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.

Product ID52427-285_0ccd1a07-3321-8416-53f4-3552e68e402d
NDC52427-285
Product TypeHuman Prescription Drug
Proprietary NameMacrobid
Generic NameNitrofurantoin Monohydrate/macrocrystalline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-05-31
Marketing CategoryNDA / NDA
Application NumberNDA020064
Labeler NameAlmatica Pharma 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 Through2021-12-31

Packaging

NDC 52427-285-01

100 CAPSULE in 1 BOTTLE (52427-285-01)
Marketing Start Date2011-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52427-285-01 [52427028501]

Macrobid CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-05-31

NDC 52427-285-10 [52427028510]

Macrobid CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2013-09-23

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

OpenFDA Data

SPL SET ID:8f270a9f-12a1-44d4-bc7e-873613555801
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755
  • 539712
    • UPC Code
  • 0352427285011

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Macrobid" or generic name "Nitrofurantoin Monohydrate/macrocrystalline"

    NDCBrand NameGeneric Name
    52427-285MacrobidNitrofurantoin Monohydrate/Macrocrystalline
    76413-113MacrobidMacrobid
    70518-2531MacrobidMacrobid
    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 Monohydrate/Macrocrystalline
    68071-1909Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline
    68001-001Nitrofurantoin Monohydrate/MacrocrystallineNitrofurantoin Monohydrate/Macrocrystalline

    Trademark Results [Macrobid]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MACROBID
    MACROBID
    73692944 1492883 Live/Registered
    NORWICH EATON PHARMACEUTICALS, INC.
    1987-11-02
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