65862-390 : Ondansetron 4 mg Disintegrating Tablet


NDC: 65862-390
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Ondansetron
Dosage Form: Oral Tablet, Orally Disintegrating
Application #: ANDA090469
Rev. Date: 


Appearance:


Markings: 5;E
Shapes:  Round
Colors:  White
Size (mm): 5
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.

5 E: (65862-390) Ondansetron 4 mg Disintegrating Tablet by Aurobindo Pharma Limited
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:

  • 65862-390-02: 100 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (65862‑390‑02)
  • 65862-390-05: 500 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (65862‑390‑05)
  • 65862-390-10: 3 BLISTER PACK IN 1 CARTON (65862‑390‑10) > 10 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK
  • 65862-390-19: 10000 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (65862‑390‑19)
  • 65862-390-30: 30 TABLET, ORALLY DISINTEGRATING IN 1 BOTTLE (65862‑390‑30)

Active Ingredients:

  • Ondansetron

Dosage Strength:

  • 4 mg

Inactive Ingredients:

  • Mannitol
  • Crospovidone
  • Lactose Monohydrate
  • Cellulose, Microcrystalline
  • Aspartame
  • Silicon Dioxide
  • Magnesium Stearate

Pharmaceutical Classes:

  • Serotonin 3 Receptor Antagonists [MoA]
  • Serotonin-3 Receptor Antagonist [EPC]

Related Products:

Based on records with the same trade name.
  • 65862-208 Ondansetron 4 mg/5ml Oral Solution by Aurobindo Pharma Limited
  • 65862-391 Ondansetron 8 mg Disintegrating Tablet by Aurobindo Pharma Limited
  • 0069-1441 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by Pfizer Laboratories Div Pfizer Inc
  • 0143-2422 Ondansetron 4 mg (Ondansetron Hydrochloride Dihydrate 5 mg) Oral Tablet by West-ward Pharmaceutical Corp
  • 0143-2423 Ondansetron 8 mg (As Ondansetron Hydrochloride Dihydrate 10 mg) Oral Tablet by West-ward Pharmaceutical Corp
  • 0143-2424 Ondansetron 24 mg (Ondansetron Hydrochloride Dihydrate 30 mg) Oral Tablet by West-ward Pharmaceutical Corp
  • 0143-9890 Ondansetron 2 mg/ml Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9891 Ondansetron 4 mg/2ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp
  • 0378-0315 Ondansetron 4 mg (Ondansetron Hydrochloride Dihydrate 5 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0344 Ondansetron 8 mg (As Ondansetron Hydrochloride Dihydrate 10 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0374 Ondansetron 24 mg (Ondansetron Hydrochloride Dihydrate 30 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7732 Ondansetron 4 mg Disintegrating Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7734 Ondansetron 8 mg Disintegrating Tablet by Mylan Pharmaceuticals Inc.
  • 0404-9930 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
  • 0409-1120 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0641-6078 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 0641-6079 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 0641-6080 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 0641-6286 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection by Hikma Pharmaceuticals USA Inc.
  • 0703-7221 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection, Solution by Teva Parenteral Medicines, 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.