CIDOFOVIR DIHYDRATE

Product NDC
23155-216
11-digit product format
231550216
Labeler code
23155
Product ID
23155-216_963405a6-8cd9-4d70-9de9-2afc6eab1488
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIDOFOVIR DIHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202501
Marketing category
ANDA
Marketing start
2012-08-06
Substance
CIDOFOVIR
Active strength
375 mg/5mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CIDOFOVIR DIHYDRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIDOFOVIR375 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJIL713Q00N
Rxcui199388

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
28c2bc40-7d76-a467-8926-be43e330e768Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-216-31CIDOFOVIR DIHYDRATE5 mL in 1 VIAL, GLASSINJECTION, SOLUTION517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-216-31ML - Milliliter23155-2165de9dd21-8898-47f9-8dfc-18e315f30d7712013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-216CIDOFOVIR DIHYDRATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 1 package rows20231026_44966a7e-d777-40fb-956f-d0f31f737848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199388cidofovir 375 MG in 5 ML InjectionPSN44966a7e-d777-40fb-956f-d0f31f73784817
1993885 ML cidofovir 75 MG/ML InjectionSCD44966a7e-d777-40fb-956f-d0f31f73784817
199388cidofovir 375 MG per 5 ML InjectionSY44966a7e-d777-40fb-956f-d0f31f73784817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-216-31231550216315 mL in 1 VIAL, GLASS (23155-216-31) 5 ml2012-08-060000-00-00NoNoCurrent