valacyclovir hydrochloride

Generic: valacyclovir hydrochloride

Labeler: time cap laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir hydrochloride
Labeler time cap laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 1 g/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-691
Product ID 49483-691_c715d9f2-9fe1-0bdd-e053-2a95a90aecf2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079012
Listing Expiration 2026-12-31
Marketing Start 2021-07-14

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 49483691
Hyphenated Format 49483-691

Supplemental Identifiers

RxCUI
313564 313565
UPC
0349483691047 0349483691504 0349483690040
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 hydrochloride (source: ndc)
Generic Name valacyclovir hydrochloride (source: ndc)
Application Number ANDA079012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (49483-691-01)
  • 30 TABLET in 1 BOTTLE (49483-691-03)
  • 10 TABLET in 1 BLISTER PACK (49483-691-04)
  • 500 TABLET in 1 BOTTLE (49483-691-50)
source: ndc

Packages (4)

49483-691-01 100 TABLET in 1 BOTTLE (49483-691-01) 49483-691-03 30 TABLET in 1 BOTTLE (49483-691-03) 49483-691-04 10 TABLET in 1 BLISTER PACK (49483-691-04) 49483-691-50 500 TABLET in 1 BOTTLE (49483-691-50)

Ingredients (1)

valacyclovir hydrochloride (1 g/1)

Linked Drug Pages (1)

Valacyclovir Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c715d9f2-9fe1-0bdd-e053-2a95a90aecf2", "openfda": {"upc": ["0349483691047", "0349483691504", "0349483690040"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["c33a2a36-16d3-4a35-e053-2995a90af240"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49483-691-01)", "package_ndc": "49483-691-01", "marketing_start_date": "20210714"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (49483-691-03)", "package_ndc": "49483-691-03", "marketing_start_date": "20210714"}, {"sample": false, "description": "10 TABLET in 1 BLISTER PACK (49483-691-04)", "package_ndc": "49483-691-04", "marketing_start_date": "20210714"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (49483-691-50)", "package_ndc": "49483-691-50", "marketing_start_date": "20210714"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "49483-691_c715d9f2-9fe1-0bdd-e053-2a95a90aecf2", "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": "49483-691", "generic_name": "Valacyclovir Hydrochloride", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "1 g/1"}], "application_number": "ANDA079012", "marketing_category": "ANDA", "marketing_start_date": "20210714", "listing_expiration_date": "20261231"}