FDA.reportPublic FDA data

Ivermectin

Product NDC
50090-5587
11-digit product format
500905587
Labeler code
50090
Product ID
50090-5587_d50e3025-7a56-450b-99d3-fdbb463c1c06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
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
ndc (product): 50090-5587
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ivermectin
Listing expiration
2027-12-31

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
104a5045-94b1-4022-bc49-719521f30f0dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5587-02023-02-07C16284748780-1f386c649-e0de-0266-e053-dadaa90a7c1aIvermectin Tablets USP, 3mg (IVERMECTIN)
50090-5587-02023-01-30C16284748780-1f386c649-e0de-0266-e053-dadaa90a7c1aIvermectin Tablets USP, 3mg (IVERMECTIN)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5587-0Ivermectin2 in 1 CARTONTABLET27
50090-5587-0Ivermectin10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5587-0EA - Each50090-55876a0cc9fc-b4d9-4026-8424-945b0f09bb9712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5587IVERMECTIN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20241114_104a5045-94b1-4022-bc49-719521f30f0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSN104a5045-94b1-4022-bc49-719521f30f0d7
311207ivermectin 3 MG Oral TabletSCD104a5045-94b1-4022-bc49-719521f30f0d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5587-0500905587002 BLISTER PACK in 1 CARTON (50090-5587-0) / 10 TABLET in 1 BLISTER PACK2 blister pack2021-07-090000-00-00NoNoCurrent