ivermectin

Product NDC
72578-120
11-digit product format
725780120
Labeler code
72578
Product ID
72578-120_23a90438-439e-4a43-86a1-ea2343657d85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivermectin
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA215210
Marketing category
ANDA
Marketing start
2023-06-10
Substance
IVERMECTIN
Active strength
10 mg/g
Pharmacologic classes
Antiparasitic [EPC], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8883YP2R6D
Rxcui1598068

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-120-02ivermectin60 g in 1 TUBECREAM605
72578-120-02ivermectin1 in 1 CARTONCREAM15
72578-120-06ivermectin1 in 1 CARTONCREAM15
72578-120-06ivermectin30 g in 1 TUBECREAM305
72578-120-08ivermectin45 g in 1 TUBECREAM455
72578-120-08ivermectin1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-120-08GM - Gram72578-1203d301d1c-db24-4222-835b-54082c688e2f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-120IVERMECTIN CREAM [VIONA PHARMACEUTICALS INC]5Current NDC, 6 package rows20240329_6b4a7400-d34c-4947-90e6-340f7087a702.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN6b4a7400-d34c-4947-90e6-340f7087a7025
1598068ivermectin 10 MG/ML Topical CreamSCD6b4a7400-d34c-4947-90e6-340f7087a7025
1598068ivermectin 1 % Topical CreamSY6b4a7400-d34c-4947-90e6-340f7087a7025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-120-02725780120021 TUBE in 1 CARTON (72578-120-02) / 60 g in 1 TUBE1 tube2023-06-10NoNoHistorical
72578-120-06725780120061 TUBE in 1 CARTON (72578-120-06) / 30 g in 1 TUBE1 tube2023-06-10NoNoHistorical
72578-120-08725780120081 TUBE in 1 CARTON (72578-120-08) / 45 g in 1 TUBE1 tube2023-06-10NoNoHistorical