10370-280 : Dutasteride and Tamsulosin Hydrochloride Oral Capsule


NDC10370-280
Labeler: Par Pharmaceutical
Product Type: Human Prescription Drug
Drug Name:  Dutasteride and Tamsulosin Hydrochloride
Dosage Form: Oral Capsule
Application #: ANDA202509
Rev. Date: 


Appearance:


Markings: C280;0504;C300
Shapes:  Capsule
Colors:  White / Blue
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:

  • 10370-280-09: 90 CAPSULE IN 1 BOTTLE (10370‑280‑09)
  • 10370-280-11: 30 CAPSULE IN 1 BOTTLE (10370‑280‑11)

Active Ingredients:

  • Dutasteride
  • Tamsulosin Hydrochloride

Dosage Strength:

  • .5 mg
  • .4 mg

Inactive Ingredients:

  • Butylated Hydroxytoluene
  • Ethylcellulose (10 Mpa.s)
  • Ferric Oxide Yellow
  • Gelatin
  • Glycerin
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Sucrose
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Hypromelloses
  • Fd&c Blue No. 1
  • Lecithin, Soybean
  • Medium-chain Triglycerides
  • Caprylic/Capric Mono/Diglycerides
  • D&c Yellow No. 10
  • Fd&c Blue No. 2
  • Propylene Glycol
  • Fd&c Red No. 40
  • Shellac
  • Polyvinyl Acetate Phthalate
  • Ammonia
  • Ferrosoferric Oxide
  • Polyethylene Glycols

Pharmaceutical Classes:

  • 5-alpha Reductase Inhibitor [EPC]
  • 5-alpha Reductase Inhibitors [MoA]
  • Adrenergic alpha-Antagonists [MoA]
  • alpha-Adrenergic Blocker [EPC]

Related Products:

Based on records with the same trade name.
  • 0591-3771 Dutasteride and Tamsulosin Hydrochloride Oral Capsule by Actavis Pharma, Inc.
  • 66993-580 Dutasteride and Tamsulosin Hydrochloride Oral Capsule by Prasco Laboratories
  • 68382-640 Dutasteride and Tamsulosin Hydrochloride Oral Capsule by Zydus Pharmaceuticals (Usa) Inc.
  • 70771-1356 Dutasteride and Tamsulosin Hydrochloride Oral Capsule by Cadila Healthcare Limited

NDC QR Code

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