0054-0546 : Telmisartan and Hydrochlorothiazide Oral Tablet


NDC0054-0546
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Telmisartan and Hydrochlorothiazide
Dosage Form: Oral Tablet
Application #: NDA021162
Rev. Date: 


Appearance:


Markings: H8;
Shapes:  Oval
Colors:  White / Red
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.

NDC Package Codes:

  • 0054-0546-18: 3 BLISTER PACK IN 1 CARTON (0054‑0546‑18) > 10 TABLET IN 1 BLISTER PACK

Active Ingredients:

  • Telmisartan
  • Hydrochlorothiazide

Dosage Strength:

  • 80 mg
  • 12.5 mg

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.
  • 0054-0545 Telmisartan and Hydrochlorothiazide Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0547 Telmisartan and Hydrochlorothiazide Oral Tablet by Roxane Laboratories, Inc.
  • 0378-2901 Telmisartan and Hydrochlorothiazide Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-2902 Telmisartan and Hydrochlorothiazide Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-2903 Telmisartan and Hydrochlorothiazide Oral Tablet by Mylan Pharmaceuticals Inc.
  • 33342-128 Telmisartan and Hydrochlorothiazide Oral Tablet by Macleods Pharmaceuticals Limited
  • 33342-129 Telmisartan and Hydrochlorothiazide Oral Tablet by Macleods Pharmaceuticals Limited
  • 33342-130 Telmisartan and Hydrochlorothiazide Oral Tablet by Macleods Pharmaceuticals Limited
  • 43547-441 Telmisartan and Hydrochlorothiazide Oral Tablet by Solco Healthcare LLC
  • 43547-442 Telmisartan and Hydrochlorothiazide Oral Tablet by Solco Healthcare LLC
  • 43547-443 Telmisartan and Hydrochlorothiazide Oral Tablet by Solco Healthcare LLC
  • 62332-209 Telmisartan and Hydrochlorothiazide Oral Tablet by Alembic Pharmaceuticals Inc.
  • 62332-210 Telmisartan and Hydrochlorothiazide Oral Tablet by Alembic Pharmaceuticals Inc.
  • 62332-211 Telmisartan and Hydrochlorothiazide Oral Tablet by Alembic Pharmaceuticals Inc.
  • 63629-7546 Telmisartan and Hydrochlorothiazide Oral Tablet by Bryant Ranch Prepack
  • 63629-7854 Telmisartan and Hydrochlorothiazide Oral Tablet by Bryant Ranch Prepack
  • 65862-976 Telmisartan and Hydrochlorothiazide Oral Tablet by Aurobindo Pharma Limited
  • 65862-977 Telmisartan and Hydrochlorothiazide Oral Tablet by Aurobindo Pharma Limited
  • 65862-978 Telmisartan and Hydrochlorothiazide Oral Tablet by Aurobindo Pharma Limited
  • 68180-193 Telmisartan and Hydrochlorothiazide Oral Tablet by Lupin Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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