Ivermectin

Product NDC
45802-102
11-digit product format
458020102
Labeler code
45802
Product ID
45802-102_856fda6e-3689-4ad9-8b50-4b8a457544fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA210225
Marketing category
ANDA
Marketing start
2024-01-08
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
45802-102-84Ivermectin1 in 1 CARTONCREAM16
45802-102-84Ivermectin45 g in 1 TUBECREAM456

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-102-84GM - Gram45802-102710188df-36cb-4a2f-bfad-008f9566a33112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-102IVERMECTIN CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, 2 package rows20250516_1d3e7aea-02a4-46b1-8a14-0324e4777cb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN1061e454-d1dc-4293-b18d-9c8717fbbb40100
1598068ivermectin 10 MG/ML Topical CreamSCD1061e454-d1dc-4293-b18d-9c8717fbbb40100
1598068ivermectin 1 % Topical CreamSY1061e454-d1dc-4293-b18d-9c8717fbbb40100
1598068ivermectin 1 % Topical CreamPSN1d3e7aea-02a4-46b1-8a14-0324e4777cb46
1598068ivermectin 10 MG/ML Topical CreamSCD1d3e7aea-02a4-46b1-8a14-0324e4777cb46
1598068ivermectin 1 % Topical CreamSY1d3e7aea-02a4-46b1-8a14-0324e4777cb46
1598068ivermectin 1 % Topical CreamPSN75973e89-a03f-48dd-8fe8-8eafc1938d092
1598068ivermectin 10 MG/ML Topical CreamSCD75973e89-a03f-48dd-8fe8-8eafc1938d092
1598068ivermectin 1 % Topical CreamSY75973e89-a03f-48dd-8fe8-8eafc1938d092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45802-102-84458020102841 TUBE in 1 CARTON (45802-102-84) / 45 g in 1 TUBE1 tube2024-01-08NoNoCurrent