valganciclovir hydrochloride

Generic: valganciclovir hydrochloride

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valganciclovir hydrochloride
Generic Name valganciclovir hydrochloride
Labeler ajanta pharma usa inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

valganciclovir hydrochloride 50 mg/mL

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-159
Product ID 27241-159_6f6211f4-3501-4957-92a1-bd68f2962203
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212890
Listing Expiration 2027-12-31
Marketing Start 2020-01-13

Pharmacologic Class

Classes
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc] dna polymerase inhibitors [moa] nucleoside analog antiviral [epc] nucleoside analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241159
Hyphenated Format 27241-159

Supplemental Identifiers

RxCUI
863559
UPC
0327241159190
UNII
4P3T9QF9NZ

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 valganciclovir hydrochloride (source: ndc)
Generic Name valganciclovir hydrochloride (source: ndc)
Application Number ANDA212890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (27241-159-19) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

27241-159-19 1 POUCH in 1 CARTON (27241-159-19) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE

Ingredients (1)

valganciclovir hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Valganciclovir hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6f6211f4-3501-4957-92a1-bd68f2962203", "openfda": {"upc": ["0327241159190"], "unii": ["4P3T9QF9NZ"], "rxcui": ["863559"], "spl_set_id": ["178a014b-92c7-44a7-abb8-95d89a2feb8f"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (27241-159-19)  / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE", "package_ndc": "27241-159-19", "marketing_start_date": "20200113"}], "brand_name": "Valganciclovir hydrochloride", "product_id": "27241-159_6f6211f4-3501-4957-92a1-bd68f2962203", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "27241-159", "generic_name": "Valganciclovir hydrochloride", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valganciclovir hydrochloride", "active_ingredients": [{"name": "VALGANCICLOVIR HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA212890", "marketing_category": "ANDA", "marketing_start_date": "20200113", "listing_expiration_date": "20271231"}