0955-1046 : Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet


NDC: 0955-1046
Labeler: Winthrop U.S.
Product Type: Human Prescription Drug
Drug Name:  Irbesartan and Hydrochlorothiazide
Dosage Form: Oral Tablet, Film Coated
Application #: NDA020758
Rev. Date: 


Appearance:


Markings: 2876
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.

2876: (0955-1046) Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Winthrop U.S.
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:

  • 0955-1046-30: 30 TABLET, FILM COATED IN 1 BOTTLE (0955‑1046‑30)
  • 0955-1046-90: 90 TABLET, FILM COATED IN 1 BOTTLE (0955‑1046‑90)

Active Ingredients:

  • Hydrochlorothiazide
  • Irbesartan

Dosage Strength:

  • 12.5 mg
  • 300 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Hypromelloses
  • Magnesium Stearate
  • Silicon Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Polyethylene Glycols
  • 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.
  • 0955-1045 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Winthrop U.S.
  • 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
  • 29300-215 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-216 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Unichem Pharmaceuticals (Usa), Inc.
  • 33342-057 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Macleods Pharmaceuticals Limited
  • 33342-058 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Macleods Pharmaceuticals Limited
  • 42291-340 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Avkare, Inc.
  • 42291-341 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Avkare, Inc.
  • 42291-342 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Avkare, Inc.
  • More related products ...

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.