Ivermectin

Product NDC
63629-8754
11-digit product format
636298754
Labeler code
63629
Product ID
63629-8754_341828c2-badd-4af4-9077-f0a5a3be130d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA210019
Marketing category
ANDA
Marketing start
2019-10-14
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
63629-8754-1Ivermectin45 g in 1 TUBECREAM45103
63629-8754-1Ivermectin1 in 1 CARTONCREAM1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8754-1GM - Gram63629-87543d01ded4-b40c-4506-8f61-5b8244a469f612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8754IVERMECTIN CREAM [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20231031_81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc103
1598068ivermectin 10 MG/ML Topical CreamSCD81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc103
1598068ivermectin 1 % Topical CreamSY81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8754-1636298754011 TUBE in 1 CARTON (63629-8754-1) / 45 g in 1 TUBE1 tube2021-08-200000-00-00NoNoCurrent