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 ID: 54348-849_8f76c341-a390-7d4e-e053-2995a90a6aea
• NDC: 54348-849
• Product Type: Human Prescription Drug
• Proprietary Name: Nitrofurantoin Mono
• Generic Name: Nitrofurantoin Monohydrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-10
• Marketing Category: NDA / NDA
• Application Number: NDA020064
• Labeler Name: PharmPak, Inc.
• Substance Name: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
• Active Ingredient Strength: 25 mg/1; mg/1
• Pharm Classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54348-849-06

1 BOTTLE in 1 BOX (54348-849-06) > 6 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2019-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54348-849-06 [54348084906]

Nitrofurantoin Mono CAPSULE

• Marketing Category: NDA
• Application Number: NDA020064
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-10

NDC 54348-849-14 [54348084914]

Nitrofurantoin Mono CAPSULE

• Marketing Category: NDA
• Application Number: NDA020064
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-10

NDC 54348-849-10 [54348084910]

Nitrofurantoin Mono CAPSULE

• Marketing Category: NDA
• Application Number: NDA020064
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-10

Drug Details

Active Ingredients

Ingredient	Strength
NITROFURANTOIN	25 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"

NDC	Brand Name	Generic Name
54348-849	Nitrofurantoin Mono	NITROFURANTOIN MONOHYDRATE
52959-783	NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE	NITROFURANTOIN MONOHYDRATE
61919-021	NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE	NITROFURANTOIN MONOHYDRATE