NDC 68071-4535

Nitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals)

Nitrofurantoin Monohydrate/macrocrystals

Nitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

Product ID68071-4535_848d0c48-cdce-7eb8-e053-2a91aa0a6ea9
NDC68071-4535
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals)
Generic NameNitrofurantoin Monohydrate/macrocrystals
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA207372
Labeler NameNuCare 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 Through2020-12-31

Packaging

NDC 68071-4535-2

2 CAPSULE in 1 BOTTLE (68071-4535-2)
Marketing Start Date2018-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4535-2 [68071453502]

Nitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA207372
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-22

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1

OpenFDA Data

SPL SET ID:74081802-b870-9430-e053-2a91aa0ac31e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648755
    • UPC Code
  • 0368071453560

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60687-633NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    60760-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    67296-1640NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    68071-4531NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    68788-7276NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70518-0799NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    70934-129NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystals
    68071-4535Nitrofurantoin monohydrate/macrocrystalsNitrofurantoin monohydrate/macrocrystals
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