NDC 71335-0500

Nitrofurantion Macrocrystals

Nitrofurantoin Macrocrystals

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

Product ID71335-0500_39caa691-b9b8-4530-8233-12160d488802
NDC71335-0500
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantion Macrocrystals
Generic NameNitrofurantoin Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-09-27
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NameBryant Ranch Prepack
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71335-0500-1

40 CAPSULE in 1 BOTTLE (71335-0500-1)
Marketing Start Date2012-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0500-9 [71335050009]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-6 [71335050006]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-2 [71335050002]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-7 [71335050007]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-3 [71335050003]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-5 [71335050005]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-1 [71335050001]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-8 [71335050008]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

NDC 71335-0500-4 [71335050004]

Nitrofurantion Macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:140dcfd4-16f8-405b-a0d5-79fdd5f44889
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 "Nitrofurantoin Macrocrystals"

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

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