NDC 68788-6874

Nitrofurantion Macrocrystals

Nitrofurantion Macrocrystals

Nitrofurantion Macrocrystals is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Nitrofurantoin.

Product ID68788-6874_c9ed2b81-d847-4e22-bf38-c4adc9095079
NDC68788-6874
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion Macrocrystals
Generic NameNitrofurantion Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-01-19
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-6874-1

100 CAPSULE in 1 BOTTLE, PLASTIC (68788-6874-1)
Marketing Start Date2017-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6874-1 [68788687401]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-19
Marketing End Date2019-11-06

NDC 68788-6874-3 [68788687403]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-19
Marketing End Date2019-11-06

NDC 68788-6874-6 [68788687406]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-19
Marketing End Date2019-11-06

NDC 68788-6874-9 [68788687409]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-19
Marketing End Date2019-11-06

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN50 mg/1

OpenFDA Data

SPL SET ID:c9ed2b81-d847-4e22-bf38-c4adc9095079
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311995
  • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

    NDC Crossover Matching brand name "Nitrofurantion Macrocrystals" or generic name "Nitrofurantion Macrocrystals"

    NDCBrand NameGeneric Name
    12634-415Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    33261-226Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    50090-0314Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    50436-0308Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    55700-295Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    55700-388Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    63187-245Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    63629-6653Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    66267-156Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    68788-6874Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    70518-0103Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    71205-023Nitrofurantion MacrocrystalsNitrofurantion Macrocrystals
    71335-0500Nitrofurantion Macrocrystalsnitrofurantoin macrocrystals
    76413-144NitrofurantoinNitrofurantion Macrocrystals

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.