NDC 50268-623

Nitrofurantoin Macrocrystals

Nitrofurantoin Macrocrystals

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

Product ID50268-623_6d87ad99-1132-562d-e053-2991aa0a8d8a
NDC50268-623
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Macrocrystals
Generic NameNitrofurantoin Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA073671
Labeler NameAvPAK
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50268-623-15

50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15) > 1 CAPSULE in 1 BLISTER PACK (50268-623-11)
Marketing Start Date2017-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-623-15 [50268062315]

Nitrofurantoin Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA073671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-08

NDC 50268-623-11 [50268062311]

Nitrofurantoin Macrocrystals CAPSULE
Marketing CategoryANDA
Application NumberANDA073671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-08

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN50 mg/1

OpenFDA Data

SPL SET ID:650f3c60-d45d-4358-a388-7efee4ad0497
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759
  • 311995

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

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

    NDCBrand NameGeneric Name
    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
    68001-002Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68001-003Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68071-4644Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68071-4681Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68071-4688nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    68084-077Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68084-078Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    68382-560nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    68382-559nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    70771-1171nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    70771-1170nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    50268-624Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    50268-623Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    50436-6591Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    60687-316Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    61919-458NITROFURANTOIN MACROCRYSTALSNITROFURANTOIN MACROCRYSTALS
    63629-4792Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    67296-0658Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    70934-217Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    71205-297Nitrofurantoin MacrocrystalsNitrofurantoin Macrocrystals
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.