NDC 63629-1459

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/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 Monohydrate; Nitrofurantoin.

Product ID63629-1459_06fa3860-5119-40a7-ba69-0ab914bed3cd
NDC63629-1459
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (monohydrate/macrocrystals)
Generic NameNitrofurantoin (monohydrate/macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA077066
Labeler NameBryant Ranch Prepack
Substance NameNITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active Ingredient Strength75 mg/1; mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-1459-1

40 CAPSULE in 1 BOTTLE (63629-1459-1)
Marketing Start Date2005-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1459-2 [63629145902]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-13
Inactivation Date2020-01-31

NDC 63629-1459-7 [63629145907]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-18
Inactivation Date2020-01-31

NDC 63629-1459-9 [63629145909]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-04-13
Inactivation Date2020-01-31

NDC 63629-1459-3 [63629145903]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-13
Inactivation Date2020-01-31

NDC 63629-1459-1 [63629145901]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-13
Inactivation Date2020-01-31

NDC 63629-1459-8 [63629145908]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-04-13
Inactivation Date2020-01-31

NDC 63629-1459-6 [63629145906]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-18
Inactivation Date2020-01-31

NDC 63629-1459-4 [63629145904]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-18
Inactivation Date2020-01-31

NDC 63629-1459-5 [63629145905]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:d0820e60-05a4-5072-05f3-fe01883cd985
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755

    • Pharmacological Class

    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]
    • Nitrofurans [CS]
    • Nitrofuran Antibacterial [EPC]

    NDC Crossover Matching brand name "Nitrofurantoin (monohydrate/macrocrystals)" or generic name "Nitrofurantoin (monohydrate/macrocrystals)"

    NDCBrand NameGeneric Name
    0185-0122Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    0480-3470Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    16714-439Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    21695-300Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    55700-822Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    59746-762NITROFURANTOIN (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    60760-194Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63187-995Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63629-1459Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    63629-1748Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4367Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4428Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-5076Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68084-446Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68788-7092Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    68071-4531Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70518-1087Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70518-0799Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70934-129Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    71335-0863Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    42291-574Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50268-625Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    53002-7042Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    60760-478Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    65162-478Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    67296-1640Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    70934-269Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    55700-794Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50090-4570Nitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)
    50090-3737NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-3856NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    53002-7041NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    63629-7968NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.