16590-283 : Fluconazole 200 mg Oral Tablet


NDC: 16590-283
Labeler: Stat Rx USA LLC
Product Type: Human Prescription Drug
Drug Name:  Fluconazole
Dosage Form: Oral Tablet
Application #: ANDA076077
Rev. Date: 


Appearance:


Markings: 5413;200
Shapes:  Oval
Colors:  Pink
Size (mm): 12
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.

5413 200: (0172-5413) Fluconazole 200 mg Oral Tablet by Stat Rx USA LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 16590-283-01: 1 TABLET IN 1 BOTTLE (16590‑283‑01)
  • 16590-283-03: 3 TABLET IN 1 BOTTLE (16590‑283‑03)
  • 16590-283-30: 30 TABLET IN 1 BOTTLE (16590‑283‑30)

Active Ingredients:

  • Fluconazole

Dosage Strength:

  • 200 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Starch, Corn
  • Croscarmellose Sodium
  • Fd&c Red No. 40
  • Aluminum Oxide
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Talc

Pharmaceutical Classes:

  • Azole Antifungal [EPC]
  • Azoles [Chemical/Ingredient]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 16590-282 Fluconazole 150 mg Oral Tablet by Stat Rx USA LLC
  • 0054-0002 Fluconazole 10 mg/ml Oral Powder, for Suspension by Roxane Laboratories, Inc
  • 0054-0003 Fluconazole 40 mg/ml Oral Powder, for Suspension by Roxane Laboratories, Inc
  • 0069-0038 Fluconazole 200 mg/100ml Intravenous Injection, Solution by Pfizer Laboratories Div Pfizer Inc
  • 0069-0045 Fluconazole 400 mg/200ml Intravenous Injection, Solution by Pfizer Laboratories Div Pfizer Inc
  • 0093-5414 Fluconazole 10 mg/ml Oral Powder, for Suspension by Teva Pharmaceuticals USA Inc
  • 0093-5415 Fluconazole 40 mg/ml Oral Powder, for Suspension by Teva Pharmaceuticals USA Inc
  • 0143-9666 Fluconazole 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9667 Fluconazole 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9668 Fluconazole 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9669 Fluconazole 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9899 Fluconazole 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0172-5410 Fluconazole 50 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-5411 Fluconazole 100 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-5412 Fluconazole 150 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-5413 Fluconazole 200 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0338-6045 Fluconazole 400 mg/200ml Intravenous Injection, Solution by Baxter Healthcare Corporation
  • 0338-6046 Fluconazole 200 mg/100ml Intravenous Injection, Solution by Baxter Healthcare Corporation
  • 0378-2514 Fluconazole 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-2516 Fluconazole 100 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • More related products ...

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.