NDC 21695-184

RAZADYNE

Galantamine Hydrobromide

RAZADYNE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Galantamine Hydrobromide.

• Product ID: 21695-184_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d
• NDC: 21695-184
• Product Type: Human Prescription Drug
• Proprietary Name: RAZADYNE
• Generic Name: Galantamine Hydrobromide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2001-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA021169
• Labeler Name: Rebel Distributors Corp
• Substance Name: GALANTAMINE HYDROBROMIDE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-184-30

30 TABLET, FILM COATED in 1 BOTTLE (21695-184-30)

• Marketing Start Date: 2001-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-184-30 [21695018430]

RAZADYNE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021169
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-02-28
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	8 mg/1

OpenFDA Data

• SPL SET ID: e62efb5a-d2cc-4e11-9e61-10e65ef3d897
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • MJ4PTD2VVW
• RxNorm Concept Unique ID - RxCUI:
  • 579148
  • 602734

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