ivermectin

Product NDC
70771-1728
11-digit product format
707711728
Labeler code
70771
Product ID
70771-1728_b32bd5aa-25fa-45a8-8efc-502e16d73735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivermectin
Dosage form
CREAM
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
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
70771-1728-2ivermectin1 in 1 CARTONCREAM13
70771-1728-2ivermectin30 g in 1 TUBECREAM303
70771-1728-3ivermectin60 g in 1 TUBECREAM603
70771-1728-3ivermectin1 in 1 CARTONCREAM13
70771-1728-4ivermectin45 g in 1 TUBECREAM453
70771-1728-4ivermectin1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1728IVERMECTIN CREAM [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 6 package rows20230610_22e85f9a-0805-47f2-8709-aa6514511b04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN22e85f9a-0805-47f2-8709-aa6514511b043
1598068ivermectin 10 MG/ML Topical CreamSCD22e85f9a-0805-47f2-8709-aa6514511b043
1598068ivermectin 1 % Topical CreamSY22e85f9a-0805-47f2-8709-aa6514511b043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1728-2707711728021 TUBE in 1 CARTON (70771-1728-2) / 30 g in 1 TUBE1 tube2023-06-10NoNoHistorical
70771-1728-3707711728031 TUBE in 1 CARTON (70771-1728-3) / 60 g in 1 TUBE1 tube2023-06-10NoNoHistorical
70771-1728-4707711728041 TUBE in 1 CARTON (70771-1728-4) / 45 g in 1 TUBE1 tube2023-06-10NoNoHistorical