53002-0060 : Valacyclovir Hydrochloride 1 g/1 Oral Tablet, Film Coated


NDC: 53002-0060
Labeler: Rpk Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Valacyclovir Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA201506
Rev. Date: 


Appearance:


Markings: C3251000
Shapes:  Capsule
Colors:  Blue
Size (mm): 23
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:

  • 53002-0060-0: 30 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑0)
  • 53002-0060-1: 2 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑1)
  • 53002-0060-2: 4 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑2)
  • 53002-0060-3: 10 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑3)
  • 53002-0060-4: 14 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑4)
  • 53002-0060-5: 20 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑5)
  • 53002-0060-6: 21 TABLET, FILM COATED IN 1 BOTTLE (53002‑0060‑6)

Active Ingredients:

  • Valacyclovir Hydrochloride

Dosage Strength:

  • 1 g/1

Inactive Ingredients:

  • Crospovidone (15 Mpa.s At 5%)
  • Fd&c Blue No. 2
  • Hypromellose, Unspecified
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol, Unspecified
  • Polysorbate 80
  • Titanium Dioxide

Pharmaceutical Classes:

  • DNA Polymerase Inhibitors [MoA]
  • Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
  • Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
  • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
  • Nucleoside Analog [EXT]

Related Products:

Based on records with the same trade name.
  • 53002-0061 Valacyclovir Hydrochloride 1 g/1 Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-7830 Valacyclovir Hydrochloride 500 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 0054-0114 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0115 Valacyclovir 1 Gm Oral Tablet by Roxane Laboratories, Inc
  • 0093-7258 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7259 Valacyclovir 1 Gm Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0378-4275 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4276 Valacyclovir 1 Gm Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0591-3248 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3249 Valacyclovir 1 Gm Oral Tablet by Watson Laboratories, Inc.
  • 0781-5208 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Sandoz Inc
  • 0781-5209 Valacyclovir 1 Gm Oral Tablet by Sandoz Inc
  • 0904-6565 Valacyclovir Hydrochloride 500 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 10544-937 Valacyclovir Hydrochloride 1 g/1 Oral Tablet, Film Coated by Blenheim Pharmacal, Inc.
  • 16714-697 Valacyclovir 1 Gm Oral Tablet by Northstar Rx LLC
  • 16714-698 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Northstar Rx LLC
  • 21695-832 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Rebel Distributors Corp
  • 21695-965 Valacyclovir 1 Gm Oral Tablet by Rebel Distributors Corp
  • 42291-889 Valacyclovir 1 Gm Oral Tablet by Avkare, Inc.
  • 43063-200 Valacyclovir (As Valacyclovir Hydrochloride) 500 mg Oral Tablet by Pd-rx 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.