NDC 49442-9310

Monoferric

Ferric Derisomaltose

Monoferric is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacosmos A/s. The primary component is Ferric Derisomaltose.

• Product ID: 49442-9310_93bb10c4-9862-4eda-927f-206ab5c2f7f0
• NDC: 49442-9310
• Product Type: Human Prescription Drug
• Proprietary Name: Monoferric
• Generic Name: Ferric Derisomaltose
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-16
• Marketing Category: NDA / NDA
• Application Number: NDA208171
• Labeler Name: Pharmacosmos A/S
• Substance Name: FERRIC DERISOMALTOSE
• Active Ingredient Strength: 1000 mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 49442-9310-1

1 VIAL in 1 BOX (49442-9310-1) > 10 mL in 1 VIAL

• Marketing Start Date: 2020-01-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49442-9310-1 [49442931001]

Monoferric SOLUTION

• Marketing Category: NDA
• Application Number: NDA208171
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-16

Drug Details

Active Ingredients

Ingredient	Strength
FERRIC DERISOMALTOSE	1000 mg/10mL

NDC Crossover Matching brand name "Monoferric" or generic name "Ferric Derisomaltose"

NDC	Brand Name	Generic Name
49442-9301	Monoferric	Ferric derisomaltose
49442-9305	Monoferric	Ferric derisomaltose
49442-9310	Monoferric	Ferric derisomaltose
73594-9301	Monoferric	Ferric derisomaltose
73594-9305	Monoferric	Ferric derisomaltose
73594-9310	Monoferric	Ferric derisomaltose