NDC 50458-387

RAZADYNE

Galantamine Hydrobromide

RAZADYNE is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Galantamine Hydrobromide.

• Product ID: 50458-387_0ddefa6e-7ea6-11e8-9f45-a7959d46d017
• NDC: 50458-387
• Product Type: Human Prescription Drug
• Proprietary Name: RAZADYNE
• Generic Name: Galantamine Hydrobromide
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2004-12-24
• Marketing Category: NDA / NDA
• Application Number: NDA021615
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: GALANTAMINE HYDROBROMIDE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50458-387-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50458-387-30)

• Marketing Start Date: 2004-12-24
• Marketing End Date: 2023-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-387-30 [50458038730]

RAZADYNE CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021615
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-12-24

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	8 mg/1

OpenFDA Data

• SPL SET ID: ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • MJ4PTD2VVW
• RxNorm Concept Unique ID - RxCUI:
  • 860707
  • 860715
  • 860717
  • 860695
  • 860901
  • 860697
  • 602734
  • 310436
  • 602736
  • 602737
  • 579148
  • 310437
  • 860903
  • 860709
• UPC Code:
  • 0350458388305
  • 0350458387308
  • 0350458397604

Pharmacological Class

• Cholinesterase Inhibitor [EPC]
• Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "RAZADYNE" or generic name "Galantamine Hydrobromide"

NDC	Brand Name	Generic Name
21695-184	RAZADYNE	galantamine hydrobromide
21695-591	RAZADYNE	galantamine hydrobromide
50458-398	RAZADYNE	RAZADYNE
50458-389	RAZADYNE	RAZADYNE
50458-396	RAZADYNE	RAZADYNE
50458-387	RAZADYNE	RAZADYNE
50458-388	RAZADYNE	RAZADYNE
50458-397	RAZADYNE	RAZADYNE
0054-0137	Galantamine Hydrobromide	Galantamine Hydrobromide
10147-0881	galantamine hydrobromide	galantamine hydrobromide
10147-0882	galantamine hydrobromide	galantamine hydrobromide
10147-0883	galantamine hydrobromide	galantamine hydrobromide
10147-0891	galantamine hydrobromide	galantamine hydrobromide
10147-0892	galantamine hydrobromide	galantamine hydrobromide
10147-0893	galantamine hydrobromide	galantamine hydrobromide
43353-984	Galantamine hydrobromide	Galantamine hydrobromide
47335-835	Galantamine Hydrobromide	Galantamine Hydrobromide
47335-836	Galantamine Hydrobromide	Galantamine Hydrobromide