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:	Jun 20, 2022

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

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]

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