NDC 35356-681

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc. The primary component is Nitrofurantoin.

Product ID35356-681_9ade3622-c380-4df9-86b0-3c2ffc183626
NDC35356-681
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (macrocrystals)
Generic NameNitrofurantoin (macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA077025
Labeler NameLake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Substance NameNITROFURANTOIN
Active Ingredient Strength100 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-681-14

14 CAPSULE in 1 BOTTLE, PLASTIC (35356-681-14)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-681-28 [35356068128]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077025
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2019-08-31

NDC 35356-681-00 [35356068100]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077025
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2019-08-31

NDC 35356-681-20 [35356068120]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077025
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2019-08-31

NDC 35356-681-14 [35356068114]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA077025
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-30
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN100 mg/1

OpenFDA Data

SPL SET ID:380ec348-d23f-46d3-9c71-602d0549dc8c
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 (macrocrystals)"

    NDCBrand NameGeneric Name
    0378-1650Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
    0378-1700Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
    35356-681Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)
    55289-186Nitrofurantoin (macrocrystals)nitrofurantoin (macrocrystals)

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