cidofovir

Generic: cidofovir anhydrous

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cidofovir
Generic Name cidofovir anhydrous
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cidofovir 75 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-210
Product ID 67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201276
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

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 67457210
Hyphenated Format 67457-210

Supplemental Identifiers

RxCUI
199388
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 (source: ndc)
Generic Name cidofovir anhydrous (source: ndc)
Application Number ANDA201276 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67457-210-05 1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS

Ingredients (1)

cidofovir (75 mg/mL)

Linked Drug Pages (1)

CIDOFOVIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e7774227-c6ba-439d-a32f-01b67d010fc5", "openfda": {"unii": ["JIL713Q00N"], "rxcui": ["199388"], "spl_set_id": ["56541229-8c1a-4550-8951-2415ed08e7e9"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (67457-210-05)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "67457-210-05", "marketing_start_date": "20130603"}], "brand_name": "CIDOFOVIR", "product_id": "67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog [EXT]"], "product_ndc": "67457-210", "generic_name": "Cidofovir Anhydrous", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIDOFOVIR", "active_ingredients": [{"name": "CIDOFOVIR", "strength": "75 mg/mL"}], "application_number": "ANDA201276", "marketing_category": "ANDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}