NDC 53002-7041

Nitrofurantoin

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID53002-7041_0567ee75-6921-4d2b-b671-f0f21bda0f31
NDC53002-7041
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin
Generic NameNitrofurantoin (monohydrate/macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA077066
Labeler NameRPK Pharmaceuticals, Inc.
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 53002-7041-1

6 CAPSULE in 1 BOTTLE (53002-7041-1)
Marketing Start Date2017-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-7041-1 [53002704101]

Nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7041-2 [53002704102]

Nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7041-4 [53002704104]

Nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-7041-3 [53002704103]

Nitrofurantoin CAPSULE
Marketing CategoryANDA
Application NumberANDA077066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:393219f6-580c-4fc5-87c8-c8506380da7b
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" or generic name "Nitrofurantoin (monohydrate/macrocrystals)"

    NDCBrand NameGeneric Name
    0115-2023NitrofurantoinNitrofurantoin
    0115-2024NitrofurantoinNitrofurantoin
    0472-1992NitrofurantoinNitrofurantoin
    0591-3684NitrofurantoinNitrofurantoin
    0591-3685NitrofurantoinNitrofurantoin
    0591-3686NitrofurantoinNitrofurantoin
    0615-1308NitrofurantoinNitrofurantoin
    0615-7655NitrofurantoinNitrofurantoin
    13811-719NitrofurantoinNitrofurantoin
    16571-740NitrofurantoinNitrofurantoin
    40032-450NitrofurantoinNitrofurantoin
    42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    43386-450NitrofurantoinNitrofurantoin
    46708-389NITROFURANTOINNITROFURANTOIN
    46708-390NITROFURANTOINNITROFURANTOIN
    46708-391NITROFURANTOINNITROFURANTOIN
    50090-3737NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-3856NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    51655-611NitrofurantoinNitrofurantoin
    53002-7041NitrofurantoinNitrofurantoin (monohydrate/macrocrystals)
    53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70408-239NITROFURANTOINNITROFURANTOIN
    71335-0878NitrofurantoinNitrofurantoin
    76413-144NitrofurantoinNitrofurantoin
    65162-689NitrofurantoinNitrofurantoin
    71335-1069nitrofurantoinnitrofurantoin
    71335-1135NitrofurantoinNitrofurantoin
    63629-7968NitrofurantoinNitrofurantoin
    60687-483NitrofurantoinNitrofurantoin
    60687-472NitrofurantoinNitrofurantoin
    68071-5050NitrofurantoinNitrofurantoin
    68001-423NitrofurantoinNitrofurantoin
    71205-365NitrofurantoinNitrofurantoin
    71205-370NitrofurantoinNitrofurantoin
    71335-1374NitrofurantoinNitrofurantoin
    68071-2281NitrofurantoinNitrofurantoin
    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)
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