0378-0344 : Ondansetron 8 mg (As Ondansetron Hydrochloride Dihydrate 10 mg) Oral Tablet


NDC0378-0344
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Ondansetron
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA076930
Rev. Date: 


Appearance:


Markings: M;344
Shapes:  Round
Colors:  Orange
Size (mm): 6
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.

M 344: (0378-0344) Ondansetron 8 mg (As Ondansetron Hydrochloride Dihydrate 10 mg) Oral Tablet by Mylan Pharmaceuticals Inc.
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:

  • 0378-0344-01: 100 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0344‑01)
  • 0378-0344-05: 500 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0344‑05)
  • 0378-0344-93: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑0344‑93)

Active Ingredients:

  • Ondansetron Hydrochloride

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycols
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Triacetin
  • Fd&c Yellow No. 6

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-0315 Ondansetron 4 mg (Ondansetron Hydrochloride Dihydrate 5 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.
  • 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
  • 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.
  • 0703-7221 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection, Solution by Teva Parenteral Medicines, Inc.
  • 0703-7226 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection, Solution by Teva Parenteral Medicines, Inc.
  • 0781-3010 Ondansetron 2 mg/ml Intramuscular; Intravenous Injection, Solution by Sandoz Inc
  • 0781-5238 Ondansetron 4 mg Disintegrating Tablet by Sandoz Inc
  • 0781-5239 Ondansetron 8 mg Disintegrating Tablet by Sandoz 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.