0378-1075 : Telmisartan and Amlodipine Oral Tablet


NDC: 0378-1075
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name: Telmisartan and Amlodipine
Dosage Form: Oral Tablet
Application #: ANDA202516
Rev. Date: 


Appearance:


Markings: TA1M
Shapes:  Oval
Colors:  Blue / White
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:

  • 0378-1075-93: 30 TABLET IN 1 BOTTLE, PLASTIC (0378‑1075‑93)

Active Ingredients:

  • Telmisartan
  • Amlodipine Besylate

Dosage Strength:

  • 40 mg
  • 5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Starch, Corn
  • Fd&c Blue No. 1
  • Magnesium Stearate
  • Mannitol
  • Meglumine
  • Cellulose, Microcrystalline
  • Povidones
  • Sodium Hydroxide

Pharmaceutical Classes:

  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]
  • Calcium Channel Antagonists [MoA]
  • Dihydropyridine Calcium Channel Blocker [EPC]
  • Dihydropyridines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0378-1076 Telmisartan and Amlodipine Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-1077 Telmisartan and Amlodipine Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-1078 Telmisartan and Amlodipine Oral Tablet by Mylan Pharmaceuticals Inc.
  • 13668-343 Telmisartan and Amlodipine Oral Tablet by Torrent Pharmaceuticals Limited
  • 13668-344 Telmisartan and Amlodipine Oral Tablet by Torrent Pharmaceuticals Limited
  • 13668-345 Telmisartan and Amlodipine Oral Tablet by Torrent Pharmaceuticals Limited
  • 13668-346 Telmisartan and Amlodipine Oral Tablet by Torrent Pharmaceuticals Limited
  • 42291-793 Telmisartan and Amlodipine Oral Tablet by Avkare, Inc.
  • 42291-794 Telmisartan and Amlodipine Oral Tablet by Avkare, Inc.
  • 42291-795 Telmisartan and Amlodipine Oral Tablet by Avkare, Inc.
  • 42291-796 Telmisartan and Amlodipine Oral Tablet by Avkare, Inc.
  • 46708-184 Telmisartan and Amlodipine Oral Tablet by Alembic Pharmaceuticals Limited
  • 46708-185 Telmisartan and Amlodipine Oral Tablet by Alembic Pharmaceuticals Limited
  • 46708-186 Telmisartan and Amlodipine Oral Tablet by Alembic Pharmaceuticals Limited
  • 46708-187 Telmisartan and Amlodipine Oral Tablet by Alembic Pharmaceuticals Limited
  • 68180-196 Telmisartan and Amlodipine Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 68180-197 Telmisartan and Amlodipine Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 68180-198 Telmisartan and Amlodipine Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 68180-199 Telmisartan and Amlodipine Oral Tablet by Lupin Pharmaceuticals, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0378-1075 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.