NDC 0378-1650

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals)

Nitrofurantoin (macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Nitrofurantoin.

Product ID0378-1650_808bdd29-3806-4d9d-8701-9a898ef9a916
NDC0378-1650
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin (macrocrystals)
Generic NameNitrofurantoin (macrocrystals)
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1997-09-09
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA074967
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNITROFURANTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesNitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-1650-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1650-01)
Marketing Start Date1997-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1650-01 [00378165001]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-09
Marketing End Date2019-08-31

NDC 0378-1650-05 [00378165005]

Nitrofurantoin (macrocrystals) CAPSULE
Marketing CategoryANDA
Application NumberANDA074967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-09
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN50 mg/1

OpenFDA Data

SPL SET ID:944c0e5f-88ff-4a46-95ef-2ea7d55063ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1648759
  • 311995
  • 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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