valacyclovir

Generic: valacyclovir

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1 g/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-041
Product ID 82009-041_48e59181-d597-f69b-e063-6294a90ad434
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203047
Listing Expiration 2027-12-31
Marketing Start 2022-10-14

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 82009041
Hyphenated Format 82009-041

Supplemental Identifiers

RxCUI
313564 313565
UPC
0382009040301 0382009041902
UNII
G447S0T1VC

Packaging Origin

Original Packager
true

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (82009-041-90)
source: ndc

Packages (1)

82009-041-90 90 TABLET, FILM COATED in 1 BOTTLE (82009-041-90)

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": "48e59181-d597-f69b-e063-6294a90ad434", "openfda": {"upc": ["0382009040301", "0382009041902"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["764b0cf9-9207-404c-87a8-a1e0109af6cc"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82009-041-90)", "package_ndc": "82009-041-90", "marketing_start_date": "20221014"}], "brand_name": "Valacyclovir", "product_id": "82009-041_48e59181-d597-f69b-e063-6294a90ad434", "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": "82009-041", "generic_name": "Valacyclovir", "labeler_name": "Quallent Pharmaceuticals Health LLC", "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": "20221014", "listing_expiration_date": "20271231"}