NDC 61919-458

NITROFURANTOIN MACROCRYSTALS

Nitrofurantoin

NITROFURANTOIN MACROCRYSTALS is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Nitrofurantoin.

Product ID61919-458_66474d1d-afc9-f611-e053-2a91aa0acbf5
NDC61919-458
Product TypeHuman Prescription Drug
Proprietary NameNITROFURANTOIN MACROCRYSTALS
Generic NameNitrofurantoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-02-28
Marketing CategoryNDA / NDA
Application NumberNDA016620
Labeler NameDIRECT RX
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61919-458-02

2 CAPSULE in 1 BOTTLE (61919-458-02)
Marketing Start Date2018-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-458-02 [61919045802]

NITROFURANTOIN MACROCRYSTALS CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

NDC 61919-458-20 [61919045820]

NITROFURANTOIN MACROCRYSTALS CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

NDC 61919-458-14 [61919045814]

NITROFURANTOIN MACROCRYSTALS CAPSULE
Marketing CategoryNDA
Application NumberNDA016620
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:66474d1d-afc8-f611-e053-2a91aa0acbf5
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"

    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
    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
    43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystals
    47781-307nitrofurantoin 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
    0115-2023NitrofurantoinNitrofurantoin
    0115-2024NitrofurantoinNitrofurantoin
    0472-1992NitrofurantoinNitrofurantoin
    0591-3684NitrofurantoinNitrofurantoin
    0591-3685NitrofurantoinNitrofurantoin
    0591-3686NitrofurantoinNitrofurantoin
    0615-1308NitrofurantoinNitrofurantoin
    0615-7655NitrofurantoinNitrofurantoin
    13811-719NitrofurantoinNitrofurantoin
    16571-740NitrofurantoinNitrofurantoin
    40032-450NitrofurantoinNitrofurantoin

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