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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050742-001STROMECTOLIVERMECTIN6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-11-22
N050742-002STROMECTOLIVERMECTIN3MGTABLET / ORALABRLD, RS1998-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050742-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050742-001STROMECTOL6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-11-22a50c72e98297…
2026-08-01 22:54:322026-06N050742-002STROMECTOL3MGTABLET / ORALABRLD, RS1998-10-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N050742-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STROMECTOLIVERMECTINMerck Sharp & Dohme LLC681888c9-af79-4b7d-ae80-c3f4f6f1effd2024-09-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 050742
application number: NDA050742
ndc (product): 0006-0032

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8883YP2R6DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261314Internal RxNorm lookup
311207Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
681888c9-af79-4b7d-ae80-c3f4f6f1effdAvailable on FDA.report

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 pack2024-09-20NoNoCurrent
0006-0032-20000060032202 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK2 blister pack1996-11-220000-00-00NoNoCurrent