FDA.reportPublic FDA data

STROMECTOL

Product NDC
0006-0032
11-digit product format
000060032
Labeler code
0006
Product ID
0006-0032_200e22cc-3187-4a71-b8e1-73d90edab8bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA050742
Marketing category
NDA
Marketing start
1996-11-22
Substance
IVERMECTIN
Active strength
3 mg/1
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
STROMECTOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8883YP2R6D
Rxcui261314, 311207

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
0006-0032-01STROMECTOL10 in 1 BLISTER PACKTABLET1020
0006-0032-01STROMECTOL2 in 1 CARTONTABLET220
0006-0032-20STROMECTOL10 in 1 BLISTER PACKTABLET1020
0006-0032-20STROMECTOL2 in 1 CARTONTABLET220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0032-01EA - Each0006-0032b7f689df-5615-45b8-977c-d760437b6b2512025-07-08
0006-0032-20EA - Each0006-0032a1494d7a-4b37-4e95-b6d9-1b0d58b3088212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IVERMECTINACTIVE INGREDIENT8883YP2R6DSTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
IVERMECTINACTIVE MOIETY8883YP2R6DSTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0032STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 4 package rows20250424_681888c9-af79-4b7d-ae80-c3f4f6f1effd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSN681888c9-af79-4b7d-ae80-c3f4f6f1effd20
261314Stromectol 3 MG Oral TabletPSN681888c9-af79-4b7d-ae80-c3f4f6f1effd20
261314ivermectin 3 MG Oral Tablet [Stromectol]SBD681888c9-af79-4b7d-ae80-c3f4f6f1effd20
311207ivermectin 3 MG Oral TabletSCD681888c9-af79-4b7d-ae80-c3f4f6f1effd20
261314Stromectol 3 MG Oral TabletSY681888c9-af79-4b7d-ae80-c3f4f6f1effd20
311207ivermectin 3 MG Oral TabletPSN5d140f06-e46b-4cdd-97e4-37b6cf4ade1312
261314Stromectol 3 MG Oral TabletPSN5d140f06-e46b-4cdd-97e4-37b6cf4ade1312
261314ivermectin 3 MG Oral Tablet [Stromectol]SBD5d140f06-e46b-4cdd-97e4-37b6cf4ade1312
311207ivermectin 3 MG Oral TabletSCD5d140f06-e46b-4cdd-97e4-37b6cf4ade1312
261314Stromectol 3 MG Oral TabletSY5d140f06-e46b-4cdd-97e4-37b6cf4ade1312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0032-01000060032012 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK2 blister pack2024-09-20NoNoHistorical
0006-0032-20000060032202 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK2 blister pack1996-11-220000-00-00NoNoCurrent