valacyclovir hydrochloride

Generic: valacyclovir

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

Drug Facts

Product Profile

Brand Name valacyclovir hydrochloride
Generic Name valacyclovir
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4275
Product ID 0378-4275_eec31f7b-9bdf-4a19-84de-14a5dc5831e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078518
Listing Expiration 2027-12-31
Marketing Start 2010-05-24

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 03784275
Hyphenated Format 0378-4275

Supplemental Identifiers

RxCUI
313564 313565
UPC
0303784276938 0303784275931
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 (source: ndc)
Application Number ANDA078518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93)
source: ndc

Packages (2)

0378-4275-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77) 0378-4275-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93)

Ingredients (1)

valacyclovir hydrochloride (500 mg/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": "eec31f7b-9bdf-4a19-84de-14a5dc5831e6", "openfda": {"upc": ["0303784276938", "0303784275931"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["56bf715d-8280-4557-9f98-9693932199e5"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77)", "package_ndc": "0378-4275-77", "marketing_start_date": "20100524"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93)", "package_ndc": "0378-4275-93", "marketing_start_date": "20100524"}], "brand_name": "Valacyclovir Hydrochloride", "product_id": "0378-4275_eec31f7b-9bdf-4a19-84de-14a5dc5831e6", "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": "0378-4275", "generic_name": "valacyclovir", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir Hydrochloride", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA078518", "marketing_category": "ANDA", "marketing_start_date": "20100524", "listing_expiration_date": "20271231"}