Ivermectin

Product NDC
51316-985
11-digit product format
513160985
Labeler code
51316
Product ID
51316-985_3802b5f4-b108-3614-e063-6294a90a6674
Type
HUMAN OTC DRUG
Nonproprietary name
Ivermectin
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS Pharmacy
Application
ANDA210720
Marketing category
ANDA
Marketing start
2025-06-20
Substance
IVERMECTIN
Active strength
5 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
IVERMECTIN5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8883YP2R6D
Rxcui1246673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-985-08Ivermectin117 g in 1 TUBELOTION1172
51316-985-08Ivermectin1 in 1 CARTONLOTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246673ivermectin 0.5 % Topical LotionPSN326e85c6-b95f-6aa8-e063-6294a90a49852
1246673ivermectin 5 MG/ML Topical LotionSCD326e85c6-b95f-6aa8-e063-6294a90a49852
1246673ivermectin 0.5 % Topical LotionSY326e85c6-b95f-6aa8-e063-6294a90a49852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-985-08513160985081 TUBE in 1 CARTON (51316-985-08) / 117 g in 1 TUBE1 tube2025-06-20NoNoCurrent