FDA.reportPublic FDA data

Ivermectin

Product NDC
76413-155
11-digit product format
764130155
Labeler code
76413
Product ID
76413-155_ad836382-a68f-4794-b81b-c4e8f8748cf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
ANDA204154
Marketing category
ANDA
Marketing start
2014-11-15
Marketing end
0000-00-00
Substance
IVERMECTIN
Active strength
3 mg/1
Pharmacologic classes
Antiparasitic [EPC],Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-155IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-02IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-04IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-06IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-08IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-10IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-12IInactivated by FDA2026-07-31
excluded packagepackage76413-15576413-155-14IInactivated 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204154-001IVERMECTINIVERMECTIN3MGTABLET / ORALAB2014-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204154-001AB

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 22:54:322026-06A204154-001IVERMECTIN3MGTABLET / ORALAB2014-10-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204154-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINA-S Medication Solutions104a5045-94b1-4022-bc49-719521f30f0d2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
IvermectinIVERMECTINEdenbridge Pharmaceuticals LLC.847a1dd7-d65b-4a0e-a67d-d90392059dac2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
IvermectinIVERMECTINNuCare Pharmaceuticals,Inc.ad6539f2-94de-1bc5-e053-2a95a90a4cf22024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154
IvermectinIVERMECTINAsclemed USA, Inc.014e33e7-c07d-4feb-a2cf-7cd160b1facd2023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204154
application number: ANDA204154

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
76413-155-022020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-042020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-062020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-082020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-102020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-122020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)
76413-155-142020-01-31C16284748780-19d75b9cf-ce3f-f424-e053-dadaa90a57ceIvermectin Tablets USP, 3mg (IVERMECTIN)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-155-02Ivermectin2 in 1 BOTTLETABLET23
76413-155-04Ivermectin4 in 1 BOTTLETABLET43
76413-155-06Ivermectin6 in 1 BOTTLETABLET63
76413-155-08Ivermectin8 in 1 BOTTLETABLET83
76413-155-10Ivermectin10 in 1 BOTTLETABLET103
76413-155-12Ivermectin12 in 1 BOTTLETABLET123
76413-155-14Ivermectin14 in 1 BOTTLETABLET143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-155IVERMECTIN TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]3Legacy NDC, 7 package rows20180425_23bb1ccf-1a35-438d-a0df-3ecc4fa30033.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSN23bb1ccf-1a35-438d-a0df-3ecc4fa300333
311207ivermectin 3 MG Oral TabletSCD23bb1ccf-1a35-438d-a0df-3ecc4fa300333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-155-02764130155022 in 1 BOTTLEHistorical
76413-155-04764130155044 in 1 BOTTLEHistorical
76413-155-06764130155066 in 1 BOTTLEHistorical
76413-155-08764130155088 in 1 BOTTLEHistorical
76413-155-107641301551010 in 1 BOTTLEHistorical
76413-155-127641301551212 in 1 BOTTLEHistorical
76413-155-147641301551414 in 1 BOTTLEHistorical