67877-454 : Itraconazole 100 mg Oral Capsule, Coated Pellets


NDC: 67877-454
Labeler: Ascend Laboratories, LLC
Product Type: Human Prescription Drug
Drug Name:  Itraconazole
Dosage Form: Oral Capsule, Coated Pellets
Application #: ANDA208591
Rev. Date: 


Appearance:


Markings: ITR;100
Shapes:  Capsule
Colors:  Blue / Pink
Size (mm): 21
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:

  • 67877-454-05: 500 CAPSULE, COATED PELLETS IN 1 BOTTLE (67877‑454‑05)
  • 67877-454-30: 30 CAPSULE, COATED PELLETS IN 1 BOTTLE (67877‑454‑30)
  • 67877-454-84: 3 BLISTER PACK IN 1 CARTON (67877‑454‑84) > 10 CAPSULE, COATED PELLETS IN 1 BLISTER PACK (67877‑454‑33)
  • 67877-454-90: 90 CAPSULE, COATED PELLETS IN 1 BOTTLE (67877‑454‑90)

Active Ingredients:

  • Itraconazole

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Sucrose
  • Hypromellose 2910 (5 Mpa.s)
  • Poloxamer 188
  • Alcohol
  • Methylene Chloride
  • Polyethylene Glycol 20000
  • Talc
  • Silicon Dioxide
  • Gelatin
  • Titanium Dioxide
  • Sodium Lauryl Sulfate
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Fd&c Red No. 3
  • Shellac
  • Isopropyl Alcohol
  • Butyl Alcohol
  • Propylene Glycol
  • Ammonia
  • Potassium Hydroxide

Pharmaceutical Classes:

  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

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  • 68382-697 Itraconazole 100 mg Oral Capsule by Zydus Pharmaceuticals (Usa) Inc.
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NDC 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.