IVERMECTIN

Product NDC
68308-701
11-digit product format
683080701
Labeler code
68308
Product ID
68308-701_180415ea-bcf7-49ef-92f4-41d58324d752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IVERMECTIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Mayne Pharma Inc.
Application
NDA206255
Marketing category
NDA AUTHORIZED GENERIC
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
68308-701-45IVERMECTIN1 in 1 CARTONCREAM11
68308-701-45IVERMECTIN45 g in 1 TUBECREAM451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-701-45GM - Gram68308-7012475c767-87b9-4060-a21c-af566830d05912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-701IVERMECTIN CREAM [MAYNE PHARMA INC.]1Current NDC, 2 package rows20240108_39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1
1598068ivermectin 10 MG/ML Topical CreamSCD39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1
1598068ivermectin 1 % Topical CreamSY39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68308-701-45683080701451 TUBE in 1 CARTON (68308-701-45) / 45 g in 1 TUBE1 tube2024-01-08NoNoHistorical