NDC 52427-288

Macrodantin

Nitrofurantoin Macrocrystals

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

Product ID52427-288_1c1a367c-d30c-b44b-07fb-d260897e41ed
NDC52427-288
Product TypeHuman Prescription Drug
Proprietary NameMacrodantin
Generic NameNitrofurantoin Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-09-27
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NameAlmatica Pharma Inc.
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52427-288-01

100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01)
Marketing Start Date2010-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52427-288-01 [52427028801]

Macrodantin CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-27

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:89d8696b-f9ce-9691-6222-8416ca143bba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 207791
  • 1648759
  • 311995
  • 311994
  • 201883
  • 201882

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

    NDC Crossover Matching brand name "Macrodantin" or generic name "Nitrofurantoin Macrocrystals"

    NDCBrand NameGeneric Name
    52427-286MacrodantinMacrodantin
    52427-287MacrodantinMacrodantin
    52427-288MacrodantinMacrodantin
    0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    0440-1866Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    0904-7025nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    0904-7026nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    0904-7136nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    10544-601Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    40032-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
    40032-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
    42254-070Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    43063-400Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    43386-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
    43386-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystals
    47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystals

    Trademark Results [Macrodantin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MACRODANTIN
    MACRODANTIN
    73341387 1239148 Dead/Cancelled
    Eaton Laboratories Inc.
    1981-12-14
    MACRODANTIN
    MACRODANTIN
    73341386 1246810 Dead/Cancelled
    Eaton Laboratories Inc.
    1981-12-14
    MACRODANTIN
    MACRODANTIN
    72280521 0843999 Live/Registered
    NORWICH PHARMACAL COMPANY, THE
    1967-09-18
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