65862-753 : Valganciclovir Hydrochloride 450 mg Oral Tablet


NDC65862-753
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Valganciclovir Hydrochloride
Dosage Form: Oral Tablet
Application #: ANDA204750
Rev. Date: 


Appearance:


Markings: H;96
Shapes:  Oval
Colors:  Pink
Size (mm): 17
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:

  • 65862-753-01: 100 TABLET IN 1 BOTTLE (65862‑753‑01)
  • 65862-753-05: 500 TABLET IN 1 BOTTLE (65862‑753‑05)
  • 65862-753-18: 180 TABLET IN 1 BOTTLE (65862‑753‑18)
  • 65862-753-60: 60 TABLET IN 1 BOTTLE (65862‑753‑60)
  • 65862-753-99: 1000 TABLET IN 1 BOTTLE (65862‑753‑99)

Active Ingredients:

  • Valganciclovir Hydrochloride

Dosage Strength:

  • 450 mg

Inactive Ingredients:

  • Crospovidone
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Ferric Oxide Red
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 400
  • Polysorbate 80
  • Povidone K30
  • Titanium Dioxide

Pharmaceutical Classes:

  • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
  • DNA Polymerase Inhibitors [MoA]
  • Nucleoside Analog [EXT]
  • Nucleoside Analog Antiviral [EPC]

Related Products:

Based on records with the same trade name.
  • 27241-159 Valganciclovir Hydrochloride 50 mg/ml Oral Powder, for Solution by Ajanta Pharma Limited
  • 43598-356 Valganciclovir Hydrochloride 450 mg Oral Tablet by Dr. Reddy's Laboratories Inc
  • 63739-357 Valganciclovir Hydrochloride 450 mg Oral Tablet by Mckesson Corporation
  • 70010-051 Valganciclovir Hydrochloride Hydrochloride 50 mg/ml Oral for Solution by Granules Pharmaceuticals Inc.
  • 70069-810 Valganciclovir Hydrochloride Hydrochloride 50 mg/ml Oral for Solution by Somerset Therapeutics, LLC
  • 72205-019 Valganciclovir Hydrochloride 50 mg/ml Oral for Solution by Novadoz Pharmaceuticals LLC

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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.