54868-5983 : Exforge 10/320 (Amlodipine / Valsartan) Oral Tablet


NDC: 54868-5983
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Exforge
Dosage Form: Oral Tablet, Film Coated
Application #: NDA021990
Rev. Date: 


Appearance:


Markings: NVR;LUF
Shapes:  Oval
Colors:  Yellow
Size (mm): 19
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.

NVR LUF: (0078-0491) Exforge 10/320 (Amlodipine / Valsartan) Oral Tablet by Physicians Total Care, 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:

  • 54868-5983-0: 30 TABLET, FILM COATED IN 1 BOTTLE (54868‑5983‑0)
  • 54868-5983-1: 90 TABLET, FILM COATED IN 1 BOTTLE (54868‑5983‑1)

Active Ingredients:

  • Amlodipine Besylate
  • Valsartan

Dosage Strength:

  • 10 mg
  • 320 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Crospovidone
  • Hypromelloses
  • Ferric Oxide Yellow
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

  • Calcium Channel Antagonists [MoA]
  • Dihydropyridine Calcium Channel Blocker [EPC]
  • Dihydropyridines [Chemical/Ingredient]
  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]

Related Products:

Based on records with the same trade name.
  • 54868-5804 Exforge 10/160 Oral Tablet by Physicians Total Care, Inc.
  • 54868-5996 Exforge 5/320 (Amlodipine / Valsartan) Oral Tablet by Physicians Total Care, Inc.
  • 54868-5997 Exforge 5/160 (Amlodipine / Valsartan) Oral Tablet by Physicians Total Care, Inc.
  • 0078-0488 Exforge 5/160 (Amlodipine / Valsartan) Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0489 Exforge 10/160 Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0490 Exforge 5/320 (Amlodipine / Valsartan) Oral Tablet by Novartis Pharmaceuticals Corporation
  • 0078-0491 Exforge 10/320 (Amlodipine / Valsartan) Oral Tablet by Novartis Pharmaceuticals Corporation
  • 52125-853 Exforge Oral Tablet, Film Coated by Remedyrepack Inc.

NDC QR Code

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NDC 54868-5983 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.