67877-474 : Dabigatran Etexilate 75 mg Oral Capsule, Coated Pellets


NDC: 67877-474
Labeler: Ascend Laboratories, LLC
Product Type: Human Prescription Drug
Drug Name:  Dabigatran Etexilate
Dosage Form: Oral Capsule, Coated Pellets
Application #: ANDA208040
Rev. Date: 


Appearance:


Markings: DAB;75
Shapes:  Capsule
Colors:  White
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:

  • 67877-474-60: 1 BOTTLE IN 1 CARTON (67877‑474‑60) > 60 CAPSULE, COATED PELLETS IN 1 BOTTLE

Active Ingredients:

  • Dabigatran Etexilate Mesylate

Dosage Strength:

  • 75 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Butylated Hydroxytoluene
  • Hydroxypropyl Cellulose (Type L)
  • Citric Acid Monohydrate
  • Povidone K25
  • Talc
  • Tartaric Acid
  • Hypromellose Phthalate (24% Phthalate, 55 Cst)
  • Polyethylene Glycol 600
  • Hypromellose 2910 (6 Mpa.s)
  • Polyethylene Glycol, Unspecified
  • Titanium Dioxide
  • Polyvinyl Alcohol
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Sodium Bicarbonate
  • Shellac
  • Ferrosoferric Oxide
  • Propylene Glycol
  • Potassium Hydroxide
  • Hypromelloses
  • Ammonia
  • Fd&c Yellow No. 6 /

Pharmaceutical Classes:

  • Direct Thrombin Inhibitor [EPC]
  • Thrombin Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 67877-475 Dabigatran Etexilate 150 mg Oral Capsule, Coated Pellets by Ascend Laboratories, LLC
  • 31722-621 Dabigatran Etexilate 75 mg Oral Capsule by Camber Pharmaceuticals, Inc.
  • 31722-622 Dabigatran Etexilate 150 mg Oral Capsule by Camber Pharmaceuticals, Inc.
  • 46708-634 Dabigatran Etexilate 75 mg Oral Capsule by Alembic Pharmaceuticals Limited
  • 46708-635 Dabigatran Etexilate 110 mg Oral Capsule by Alembic Pharmaceuticals Limited
  • 46708-636 Dabigatran Etexilate 150 mg Oral Capsule by Alembic Pharmaceuticals Limited
  • 60505-4347 Dabigatran Etexilate 75 mg Oral Capsule by Apotex Corp.
  • 60505-4348 Dabigatran Etexilate 150 mg Oral Capsule by Apotex Corp.
  • 60505-4349 Dabigatran Etexilate 110 mg Oral Capsule by Apotex Corp.
  • 60687-744 Dabigatran Etexilate 75 mg Oral Capsule by American Health Packaging
  • 60687-752 Dabigatran Etexilate 150 mg Oral Capsule by American Health Packaging
  • 62332-634 Dabigatran Etexilate 75 mg Oral Capsule by Alembic Pharmaceuticals Inc.
  • 62332-635 Dabigatran Etexilate 110 mg Oral Capsule by Alembic Pharmaceuticals Inc.
  • 62332-636 Dabigatran Etexilate 150 mg Oral Capsule by Alembic Pharmaceuticals Inc.
  • 72865-272 Dabigatran Etexilate 75 mg Oral Capsule by Xlcare Pharmaceuticals, Inc.
  • 72865-273 Dabigatran Etexilate 150 mg Oral Capsule by Xlcare Pharmaceuticals, Inc.

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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.