valacyclovir

Generic: valacyclovir

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1 g/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-771
Product ID 43063-771_2c259b01-1846-32c6-e063-6394a90a3498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203047
Listing Expiration 2026-12-31
Marketing Start 2015-05-25

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063771
Hyphenated Format 43063-771

Supplemental Identifiers

RxCUI
313564
UPC
0343063771211
UNII
G447S0T1VC

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valacyclovir (source: ndc)
Generic Name valacyclovir (source: ndc)
Application Number ANDA203047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-06)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-20)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-21)
source: ndc

Packages (4)

43063-771-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-06) 43063-771-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-14) 43063-771-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-20) 43063-771-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-21)

Ingredients (1)

valacyclovir hydrochloride (1 g/1)

Linked Drug Pages (1)

Valacyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c259b01-1846-32c6-e063-6394a90a3498", "openfda": {"upc": ["0343063771211"], "unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["1b11361c-5444-498b-ab7c-fbad917705ae"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-06)", "package_ndc": "43063-771-06", "marketing_start_date": "20170608"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-14)", "package_ndc": "43063-771-14", "marketing_start_date": "20180323"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-20)", "package_ndc": "43063-771-20", "marketing_start_date": "20180326"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-21)", "package_ndc": "43063-771-21", "marketing_start_date": "20170811"}], "brand_name": "Valacyclovir", "product_id": "43063-771_2c259b01-1846-32c6-e063-6394a90a3498", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "43063-771", "generic_name": "Valacyclovir", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA203047", "marketing_category": "ANDA", "marketing_start_date": "20150525", "listing_expiration_date": "20261231"}