FDA.reportPublic FDA data

Ivermectin

Product NDC
42799-806
11-digit product format
427990806
Labeler code
42799
Product ID
42799-806_46410c0e-07e7-7194-e063-6394a90a3997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA204154
Marketing category
ANDA
Marketing start
2014-11-15
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 · 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
ndc (product): 42799-806
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ivermectin
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
847a1dd7-d65b-4a0e-a67d-d90392059dacAvailable 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
42799-806-01Ivermectin10 in 1 BLISTER PACKTABLET108
42799-806-01Ivermectin2 in 1 CARTONTABLET28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-806-01EA - Each42799-8069babec5c-e0c3-4e2f-88ab-373e81e98cde12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IVERMECTINACTIVE INGREDIENT8883YP2R6DIVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
IVERMECTINACTIVE MOIETY8883YP2R6DIVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-806IVERMECTIN TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]6Current NDC, Legacy NDC, 2 package rows20231229_847a1dd7-d65b-4a0e-a67d-d90392059dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSN847a1dd7-d65b-4a0e-a67d-d90392059dac8
311207ivermectin 3 MG Oral TabletSCD847a1dd7-d65b-4a0e-a67d-d90392059dac8
311207ivermectin 3 MG Oral TabletPSN104a5045-94b1-4022-bc49-719521f30f0d7
311207ivermectin 3 MG Oral TabletSCD104a5045-94b1-4022-bc49-719521f30f0d7
311207ivermectin 3 MG Oral TabletPSN23bb1ccf-1a35-438d-a0df-3ecc4fa300333
311207ivermectin 3 MG Oral TabletPSNad6539f2-94de-1bc5-e053-2a95a90a4cf23
311207ivermectin 3 MG Oral TabletSCD23bb1ccf-1a35-438d-a0df-3ecc4fa300333
311207ivermectin 3 MG Oral TabletSCDad6539f2-94de-1bc5-e053-2a95a90a4cf23
311207ivermectin 3 MG Oral TabletPSN014e33e7-c07d-4feb-a2cf-7cd160b1facd1
311207ivermectin 3 MG Oral TabletSCD014e33e7-c07d-4feb-a2cf-7cd160b1facd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-806-01427990806012 BLISTER PACK in 1 CARTON (42799-806-01) / 10 TABLET in 1 BLISTER PACK2 blister pack2014-11-150000-00-00NoNoCurrent