valacyclovir

Generic: valacyclovir

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
SUN PHARMACEUTICAL INDUSTRIES, INC.

Identifiers & Regulatory

Product NDC 63304-904
Product ID 63304-904_744b60c8-568b-4726-881c-68709c30f28a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076588
Listing Expiration 2026-12-31
Marketing Start 2020-12-19

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 63304904
Hyphenated Format 63304-904

Supplemental Identifiers

RxCUI
313564 313565
UPC
0363304905304 0363304904307
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 ANDA076588 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (63304-904-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (63304-904-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63304-904-30)
  • 100 BLISTER PACK in 1 CARTON (63304-904-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-904-11)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63304-904-90)
source: ndc

Packages (5)

63304-904-03 10 TABLET, FILM COATED in 1 BOTTLE (63304-904-03) 63304-904-05 500 TABLET, FILM COATED in 1 BOTTLE (63304-904-05) 63304-904-30 30 TABLET, FILM COATED in 1 BOTTLE (63304-904-30) 63304-904-77 100 BLISTER PACK in 1 CARTON (63304-904-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-904-11) 63304-904-90 90 TABLET, FILM COATED in 1 BOTTLE (63304-904-90)

Ingredients (1)

valacyclovir hydrochloride (500 mg/1)

Linked Drug Pages (1)

Valacyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "744b60c8-568b-4726-881c-68709c30f28a", "openfda": {"upc": ["0363304905304", "0363304904307"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["26634bf1-c6d8-4d48-9a4e-845c47df07f8"], "manufacturer_name": ["SUN PHARMACEUTICAL INDUSTRIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63304-904-03)", "package_ndc": "63304-904-03", "marketing_start_date": "20201219"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (63304-904-05)", "package_ndc": "63304-904-05", "marketing_start_date": "20201219"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63304-904-30)", "package_ndc": "63304-904-30", "marketing_start_date": "20201219"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (63304-904-77)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-904-11)", "package_ndc": "63304-904-77", "marketing_start_date": "20201219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63304-904-90)", "package_ndc": "63304-904-90", "marketing_start_date": "20201219"}], "brand_name": "Valacyclovir", "product_id": "63304-904_744b60c8-568b-4726-881c-68709c30f28a", "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": "63304-904", "generic_name": "Valacyclovir", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076588", "marketing_category": "ANDA", "marketing_start_date": "20201219", "listing_expiration_date": "20261231"}