67877-475 : Dabigatran Etexilate 150 mg Oral Capsule, Coated Pellets


NDC: 67877-475
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;150
Shapes:  Capsule
Colors:  Blue / White
Size (mm): 23
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:

  • 67877-475-60: 1 BOTTLE IN 1 CARTON (67877‑475‑60) > 60 CAPSULE, COATED PELLETS IN 1 BOTTLE

Active Ingredients:

  • Dabigatran Etexilate Mesylate

Dosage Strength:

  • 150 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
  • D&c Red No. 33
  • Fd&c Blue No. 1
  • Fd&c Yellow No. 6
  • Shellac
  • Ferrosoferric Oxide
  • Propylene Glycol
  • Potassium Hydroxide
  • Hypromelloses
  • Ammonia /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 67877-474 Dabigatran Etexilate 75 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.
  • 60687-744 Dabigatran Etexilate 75 mg Oral Capsule by American Health Packaging
  • 60687-752 Dabigatran Etexilate 150 mg Oral Capsule by American Health Packaging

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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.