65483-393 : Trandate 300 mg Oral Tablet

Labeler: Prometheus Laboratories Inc.
Product Type: Human Prescription Drug
Drug Name:  Trandate
Dosage Form: Oral Tablet
Application #: NDA018716
Rev. Date: 


Markings: TRANDATE;300
Shapes:  Round
Colors:  Orange
Size (mm): 11
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 65483-393-10: 100 TABLET IN 1 BOTTLE (65483‑393‑10)

Active Ingredients:

  • Labetalol Hydrochloride

Dosage Strength:

  • 300 mg

Inactive Ingredients:

  • Fd&c Yellow No. 6
  • Hypromellose 2208 (15000 Mpa.s)
  • Lactose
  • Magnesium Stearate
  • Starch, Corn
  • Titanium Dioxide

Pharmaceutical Classes:

  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]

Related Products:

Based on records with the same trade name.
  • 65483-391 Trandate 100 mg Oral Tablet by Prometheus Laboratories Inc.
  • 65483-392 Trandate 200 mg Oral Tablet by Prometheus Laboratories Inc.


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NDC 65483-393 QR Code

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Note: The MedsChat® 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.