0378-1721 : Amlodipine Besylate and Valsartan Oral Tablet, Film Coated


NDC: 0378-1721
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Amlodipine Besylate and Valsartan
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA090483
Rev. Date: 


Appearance:


Markings: MX1
Shapes:  Oval
Colors:  Orange
Size (mm): 16
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.

MX1: (0378-1721) Amlodipine Besylate and Valsartan Oral Tablet, Film Coated by Mylan 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:

  • 0378-1721-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑1721‑05)
  • 0378-1721-77: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑1721‑77)
  • 0378-1721-93: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑1721‑93)

Active Ingredients:

  • Amlodipine Besylate
  • Valsartan

Dosage Strength:

  • 5 mg
  • 160 mg

Inactive Ingredients:

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

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.
  • 0378-1722 Amlodipine Besylate and Valsartan Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-1723 Amlodipine Besylate and Valsartan Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-1724 Amlodipine Besylate and Valsartan Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0378-1721 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.