50458-398 : Razadyne 12 mg (Galantamine Hydrobromide 15.379 mg) Oral Tablet


NDC: 50458-398
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Razadyne
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021169
Rev. Date: 


Appearance:


Markings: JANSSEN;G;12
Shapes:  Round
Colors:  Brown
Size (mm): 8
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

JANSSEN G 12: (50458-398) Razadyne 12 mg (Galantamine Hydrobromide 15.379 mg) Oral Tablet by Janssen Pharmaceuticals, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 50458-398-60: 60 TABLET, FILM COATED IN 1 BOTTLE (50458‑398‑60)

Active Ingredients:

  • Galantamine Hydrobromide

Dosage Strength:

  • 12 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Red
  • D&c Yellow No. 10
  • Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50458-387 24 Hr Razadyne ER 8 mg Extended Release Capsule by Janssen Pharmaceuticals, Inc.
  • 50458-388 24 Hr Razadyne ER 16 mg Extended Release Capsule by Janssen Pharmaceuticals, Inc.
  • 50458-389 Razadyne ER 24 mg 24hr Extended Release Capsule by Janssen Pharmaceuticals, Inc.
  • 50458-396 Razadyne 4 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-397 Razadyne 8 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-490 Razadyne 4 mg/ml Oral Solution by Janssen Pharmaceuticals, Inc.
  • 21695-184 Razadyne 8 mg/1 Oral Tablet, Film Coated by Rebel Distributors Corp
  • 21695-591 Razadyne 12 mg (Galantamine Hydrobromide 15.379 mg) Oral Tablet by Rebel Distributors Corp

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.