FDA.reportPublic FDA data

STROMECTOL

Product NDC
55695-019
11-digit product format
556950019
Labeler code
55695
Product ID
55695-019_2dcafbab-38a8-2716-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
NDA050742
Marketing category
NDA
Marketing start
1996-11-22
Marketing end
0000-00-00
Substance
IVERMECTIN
Active strength
3 mg/1
Pharmacologic classes
Antiparasitic [EPC],Pediculicide [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55695-019IInactivated by FDA2026-07-31
excluded packagepackage55695-01955695-019-00IInactivated by FDA2026-07-31

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N050742-001STROMECTOLIVERMECTIN6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-11-22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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-019-002020-01-31C16284748780-19d75b9d1-260d-f424-e053-dadaa90a57ceSTROMECTOL® (IVERMECTIN) TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-019-00STROMECTOL10 in 1 BLISTER PACKTABLET1012
55695-019-00STROMECTOL2 in 1 CARTONTABLET212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-019STROMECTOL (IVERMECTIN) TABLET [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]12Legacy NDC, 2 package rows20160311_5d140f06-e46b-4cdd-97e4-37b6cf4ade13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
55695-019-005569500190010 in 1 BLISTER PACKHistorical