NDC 12634-415

Nitrofurantion Macrocrystals

Nitrofurantion Macrocrystals

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

Product ID12634-415_27fa784f-085a-0b97-e054-00144ff8d46c
NDC12634-415
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion Macrocrystals
Generic NameNitrofurantion Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-09-27
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NameApotheca Inc.
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-415-00

10 CAPSULE in 1 BOTTLE (12634-415-00)
Marketing Start Date2010-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-415-00 [12634041500]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-27
Inactivation Date2020-01-31

NDC 12634-415-84 [12634041584]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:27fa784f-0859-0b97-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759

    • 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
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