64380-197 : Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated


NDC: 64380-197
Labeler: Strides Pharma Science Limited
Product Type: Human Prescription Drug
Drug Name: Amlodipine, Valsartan, Hydrochlorothiazide
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA201087
Rev. Date: 


NDC Package Codes:

  • 64380-197-01: 30 TABLET, FILM COATED IN 1 BOTTLE (64380‑197‑01)
  • 64380-197-02: 90 TABLET, FILM COATED IN 1 BOTTLE (64380‑197‑02)
  • 64380-197-03: 500 TABLET, FILM COATED IN 1 BOTTLE (64380‑197‑03)

Active Ingredients:

  • Amlodipine Besylate
  • Hydrochlorothiazide
  • Valsartan

Dosage Strength:

  • 5 mg
  • 12.5 mg
  • 160 mg

Pharmaceutical Classes:

  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]
  • Calcium Channel Antagonists [MoA]
  • Calcium Channel Blocker [EPC]
  • Cytochrome P450 3A Inhibitors [MoA]
  • Dihydropyridine Calcium Channel Blocker [EPC]
  • Dihydropyridines [CS]
  • Increased Diuresis [PE]
  • Thiazide Diuretic [EPC]
  • Thiazides [CS]

Related Products:

Based on records with the same trade name.
  • 64380-198 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Strides Pharma Science Limited
  • 64380-199 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Strides Pharma Science Limited
  • 64380-200 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Strides Pharma Science Limited
  • 64380-201 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Strides Pharma Science Limited
  • 0781-5756 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5760 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5771 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5787 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Sandoz Inc
  • 0781-5794 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Sandoz Inc
  • 49884-172 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-173 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-174 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-175 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 49884-185 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Par Pharmaceutical Inc.
  • 51407-668 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Golden State Medical Supply, Inc.
  • 51407-669 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Golden State Medical Supply, Inc.
  • 51407-670 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Golden State Medical Supply, Inc.
  • 51407-671 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Golden State Medical Supply, Inc.
  • 51407-672 Amlodipine, Valsartan, Hydrochlorothiazide Oral Tablet, Film Coated by Golden State Medical Supply, Inc.

NDC QR Code

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NDC 64380-197 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.