NDC 43063-400

Nitrofurantoin Macrocrystals

Nitrofurantoin Macrocrystals

Nitrofurantoin Macrocrystals is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Nitrofurantoin.

Product ID43063-400_7380196e-094e-1965-e053-2a91aa0ae912
NDC43063-400
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Macrocrystals
Generic NameNitrofurantoin Macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-09-27
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-400-02

2 CAPSULE in 1 BOTTLE, PLASTIC (43063-400-02)
Marketing Start Date2011-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-400-12 [43063040012]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

NDC 43063-400-20 [43063040020]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

NDC 43063-400-40 [43063040040]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

NDC 43063-400-10 [43063040010]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

NDC 43063-400-02 [43063040002]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

NDC 43063-400-28 [43063040028]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13

NDC 43063-400-30 [43063040030]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13

NDC 43063-400-14 [43063040014]

nitrofurantoin macrocrystals CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-13

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:a1f947e2-caec-4091-a3c9-98a0f8acd8d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759

    • 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.