valacyclovir

Generic: valacyclovir

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1000 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4100
Product ID 70518-4100_4c9a1905-a99c-3ba5-e063-6394a90ab5bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2027-12-31
Marketing Start 2024-06-12

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 705184100
Hyphenated Format 70518-4100

Supplemental Identifiers

RxCUI
313564
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 ANDA209553 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0)
  • 14 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2)
  • 7 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3)
  • 4 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4)
  • 10 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5)
  • 20 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6)
source: ndc

Packages (6)

70518-4100-0 30 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0) 70518-4100-2 14 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2) 70518-4100-3 7 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3) 70518-4100-4 4 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4) 70518-4100-5 10 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5) 70518-4100-6 20 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6)

Ingredients (1)

valacyclovir hydrochloride (1000 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": "4c9a1905-a99c-3ba5-e063-6394a90ab5bb", "openfda": {"unii": ["G447S0T1VC"], "rxcui": ["313564"], "spl_set_id": ["5e39bf80-ada6-4194-bf3d-2c044c3389da"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0)", "package_ndc": "70518-4100-0", "marketing_start_date": "20240612"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2)", "package_ndc": "70518-4100-2", "marketing_start_date": "20240612"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3)", "package_ndc": "70518-4100-3", "marketing_start_date": "20240709"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4)", "package_ndc": "70518-4100-4", "marketing_start_date": "20240804"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5)", "package_ndc": "70518-4100-5", "marketing_start_date": "20250402"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6)", "package_ndc": "70518-4100-6", "marketing_start_date": "20250823"}], "brand_name": "Valacyclovir", "product_id": "70518-4100_4c9a1905-a99c-3ba5-e063-6394a90ab5bb", "dosage_form": "TABLET", "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": "70518-4100", "generic_name": "Valacyclovir", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA209553", "marketing_category": "ANDA", "marketing_start_date": "20240612", "listing_expiration_date": "20271231"}