FDA.reportPublic FDA data

Acyclovir

Product NDC
45802-044
11-digit product format
458020044
Labeler code
45802
Product ID
45802-044_02b3e4ad-6b52-4766-99fb-3edd6119c9b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA208702
Marketing category
ANDA
Marketing start
2019-02-11
Substance
ACYCLOVIR
Active strength
50 mg/g
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui141859

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-044-75Acyclovir5 g in 1 TUBECREAM55
45802-044-75Acyclovir1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-044-75GM - Gram45802-044f0d57b90-fe1b-4c4a-888b-7818c43f907612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-044ACYCLOVIR CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20250202_63fadf54-e8a3-4512-8a05-d64b998f5a08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSN63fadf54-e8a3-4512-8a05-d64b998f5a085
141859acyclovir 50 MG/ML Topical CreamSCD63fadf54-e8a3-4512-8a05-d64b998f5a085
141859acyclovir 5 % Topical CreamSY63fadf54-e8a3-4512-8a05-d64b998f5a085
141859acycycloguanosine 50 MG/ML Topical CreamSY63fadf54-e8a3-4512-8a05-d64b998f5a085
141859acyclovir 5 % Topical CreamPSN67a7ab8b-4b85-4f7b-8ae0-3dcdc273ed691
141859acyclovir 50 MG/ML Topical CreamSCD67a7ab8b-4b85-4f7b-8ae0-3dcdc273ed691
141859acyclovir 5 % Topical CreamSY67a7ab8b-4b85-4f7b-8ae0-3dcdc273ed691
141859acycycloguanosine 50 MG/ML Topical CreamSY67a7ab8b-4b85-4f7b-8ae0-3dcdc273ed691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-044-75458020044751 TUBE in 1 CARTON (45802-044-75) / 5 g in 1 TUBE1 tube2019-02-110000-00-00NoNoCurrent