valacyclovir

Generic: valacyclovir

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

Drug Facts

Product Profile

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

valacyclovir hydrochloride 1 g/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-705
Product ID 31722-705_461ff6f2-7bf1-82fb-e063-6294a90acb06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203047
Listing Expiration 2026-12-31
Marketing Start 2015-05-25

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 31722705
Hyphenated Format 31722-705

Supplemental Identifiers

RxCUI
313564 313565
UPC
0331722704304 0331722705301
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-705-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-705-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-705-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-705-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-705-90)
source: ndc

Packages (5)

31722-705-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-705-01) 31722-705-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-705-05) 31722-705-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-705-30) 31722-705-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-705-60) 31722-705-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-705-90)

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": "461ff6f2-7bf1-82fb-e063-6294a90acb06", "openfda": {"upc": ["0331722704304", "0331722705301"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["7f5e96e0-534c-47a5-bb79-926088afc73c"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-705-01)", "package_ndc": "31722-705-01", "marketing_start_date": "20150525"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-705-05)", "package_ndc": "31722-705-05", "marketing_start_date": "20150525"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-705-30)", "package_ndc": "31722-705-30", "marketing_start_date": "20150525"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-705-60)", "package_ndc": "31722-705-60", "marketing_start_date": "20150525"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-705-90)", "package_ndc": "31722-705-90", "marketing_start_date": "20150525"}], "brand_name": "Valacyclovir", "product_id": "31722-705_461ff6f2-7bf1-82fb-e063-6294a90acb06", "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": "31722-705", "generic_name": "Valacyclovir", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20150525", "listing_expiration_date": "20261231"}