57297-414 : Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated
NDC: | 57297-414 |
Labeler: | Lupin Limited |
Product Type: | Human Prescription Drug |
Drug Name: | Irbesartan and Hydrochlorothiazide |
Dosage Form: | Oral Tablet, Film Coated |
Application #: | ANDA201524 |
Rev. Date: |
Appearance:
Markings: | L059 |
Shapes: |
Oval |
Colors: |
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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. |
NDC Package Codes:
- 57297-414-06: 30 TABLET, FILM COATED IN 1 BOTTLE (57297‑414‑06)
- 57297-414-09: 90 TABLET, FILM COATED IN 1 BOTTLE (57297‑414‑09)
Active Ingredients:
- Hydrochlorothiazide
- Irbesartan
Dosage Strength:
- 12.5 mg
- 300 mg
Inactive Ingredients:
- Ferric Oxide Yellow
- Mannitol
- Polyethylene Glycol 3350
- Silicon Dioxide
- Hypromellose 2910 (15 Mpa.s)
- Poloxamer 188
- Crospovidone
- Shellac
- Magnesium Stearate
- Propylene Glycol
- Titanium Dioxide
- Ferric Oxide Red
- Ferrosoferric Oxide
Pharmaceutical Classes:
- Increased Diuresis [PE]
- Thiazide Diuretic [EPC]
- Thiazides [CS]
- Angiotensin 2 Receptor Antagonists [MoA]
- Angiotensin 2 Receptor Blocker [EPC]
Related Products:
Based on records with the same trade name.- 57297-413 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Lupin Limited
- 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.
- 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.
- More related products ...
NDC QR Code
Scan the QR code below to easily reference this data in the future:![NDC 57297-414 QR Code](/images/NDC-QR/57297-414-QR.png)
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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.