71335-1392 : Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated


NDC: 71335-1392
Labeler: Bryant Ranch Prepack
Product Type: Human Prescription Drug
Drug Name:  Irbesartan and Hydrochlorothiazide
Dosage Form: Oral Tablet, Film Coated
Application #: NDA020758
Rev. Date: 


Appearance:


Markings: 2875
Shapes:  Oval
Colors:  Orange
Size (mm): 13
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.

2875: (0955-1045) Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Bryant Ranch Prepack
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:

  • 71335-1392-1: 30 TABLET, FILM COATED IN 1 BOTTLE (71335‑1392‑1)
  • 71335-1392-2: 90 TABLET, FILM COATED IN 1 BOTTLE (71335‑1392‑2)
  • 71335-1392-3: 28 TABLET, FILM COATED IN 1 BOTTLE (71335‑1392‑3)

Active Ingredients:

  • Hydrochlorothiazide
  • Irbesartan

Dosage Strength:

  • 12.5 mg
  • 150 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Hypromellose, Unspecified
  • Magnesium Stearate
  • Silicon Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Polyethylene Glycol, Unspecified
  • Titanium Dioxide
  • Carnauba Wax /

Pharmaceutical Classes:

  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]
  • Increased Diuresis [PE]
  • Thiazide Diuretic [EPC]
  • Thiazides [CS]

Related Products:

Based on records with the same trade name.
  • 71335-1097 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 71335-1787 Irbesartan and Hydrochlorothiazide Oral Tablet by Bryant Ranch Prepack
  • 71335-2099 Irbesartan and Hydrochlorothiazide Oral Tablet by Bryant Ranch Prepack
  • 63629-7468 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 72162-1035 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Bryant Ranch Prepack
  • 72162-2317 Irbesartan and Hydrochlorothiazide Oral Tablet by Bryant Ranch Prepack
  • 0054-0254 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0255 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0093-7238 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7239 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8232 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8238 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0378-3033 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3034 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0591-2785 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2786 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-4088 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-4089 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0955-1045 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Winthrop U.S.
  • 0955-1046 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Winthrop U.S.
  • More related products ...

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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.