68382-697 : Itraconazole 100 mg Oral Capsule


NDC: 68382-697
Labeler: Zydus Pharmaceuticals (Usa) Inc.
Product Type: Human Prescription Drug
Drug Name:  Itraconazole
Dosage Form: Oral Capsule
Application #: ANDA204672
Rev. Date: 


Appearance:


Markings: ZA;65;100;mg
Shapes:  Capsule
Colors:  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:

  • 68382-697-01: 100 CAPSULE IN 1 BOTTLE (68382‑697‑01)
  • 68382-697-06: 30 CAPSULE IN 1 BOTTLE (68382‑697‑06)
  • 68382-697-10: 1000 CAPSULE IN 1 BOTTLE (68382‑697‑10)
  • 68382-697-77: 10 BLISTER PACK IN 1 CARTON (68382‑697‑77) > 10 CAPSULE IN 1 BLISTER PACK (68382‑697‑30)

Active Ingredients:

  • Itraconazole

Dosage Strength:

  • 100 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

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

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NDC QR Code

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NDC 68382-697 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.