cidofovir dihydrate

Generic: cidofovir dihydrate

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cidofovir dihydrate
Generic Name cidofovir dihydrate
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cidofovir 375 mg/5mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-216
Product ID 23155-216_963405a6-8cd9-4d70-9de9-2afc6eab1488
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202501
Listing Expiration 2026-12-31
Marketing Start 2012-08-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155216
Hyphenated Format 23155-216

Supplemental Identifiers

RxCUI
199388
UPC
0323155216318
UNII
JIL713Q00N

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 cidofovir dihydrate (source: ndc)
Generic Name cidofovir dihydrate (source: ndc)
Application Number ANDA202501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 375 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, GLASS (23155-216-31)
source: ndc

Packages (1)

23155-216-31 5 mL in 1 VIAL, GLASS (23155-216-31)

Ingredients (1)

cidofovir (375 mg/5mL)

Linked Drug Pages (1)

CIDOFOVIR DIHYDRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "963405a6-8cd9-4d70-9de9-2afc6eab1488", "openfda": {"upc": ["0323155216318"], "unii": ["JIL713Q00N"], "rxcui": ["199388"], "spl_set_id": ["44966a7e-d777-40fb-956f-d0f31f737848"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, GLASS (23155-216-31)", "package_ndc": "23155-216-31", "marketing_start_date": "20120806"}], "brand_name": "CIDOFOVIR DIHYDRATE", "product_id": "23155-216_963405a6-8cd9-4d70-9de9-2afc6eab1488", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog [EXT]"], "product_ndc": "23155-216", "generic_name": "CIDOFOVIR DIHYDRATE", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIDOFOVIR DIHYDRATE", "active_ingredients": [{"name": "CIDOFOVIR", "strength": "375 mg/5mL"}], "application_number": "ANDA202501", "marketing_category": "ANDA", "marketing_start_date": "20120806", "listing_expiration_date": "20261231"}