NDC 63187-995

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 Proficient Rx Lp. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID63187-995_28ad2b2e-0010-47a5-bb3f-92aabc90f1a4
NDC63187-995
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 NameProficient Rx LP
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 Through2020-12-31

Packaging

NDC 63187-995-10

10 CAPSULE in 1 BOTTLE (63187-995-10)
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-995-20 [63187099520]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-01

NDC 63187-995-10 [63187099510]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-01

NDC 63187-995-14 [63187099514]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:d802d734-dc8f-4f3c-bce6-aaccc4614c89
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)
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