NDC 54348-849

Nitrofurantoin Mono

Nitrofurantoin Monohydrate

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

Product ID54348-849_8f76c341-a390-7d4e-e053-2995a90a6aea
NDC54348-849
Product TypeHuman Prescription Drug
Proprietary NameNitrofurantoin Mono
Generic NameNitrofurantoin Monohydrate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryNDA / NDA
Application NumberNDA020064
Labeler NamePharmPak, Inc.
Substance NameNITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active Ingredient Strength25 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 54348-849-06

1 BOTTLE in 1 BOX (54348-849-06) > 6 CAPSULE in 1 BOTTLE
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-849-06 [54348084906]

Nitrofurantoin Mono CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-849-14 [54348084914]

Nitrofurantoin Mono CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-849-10 [54348084910]

Nitrofurantoin Mono CAPSULE
Marketing CategoryNDA
Application NumberNDA020064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
NITROFURANTOIN25 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Nitrofurantoin Mono" or generic name "Nitrofurantoin Monohydrate"

NDCBrand NameGeneric Name
54348-849Nitrofurantoin MonoNITROFURANTOIN MONOHYDRATE
52959-783NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATE
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATE

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