Ivermectin

Product NDC
51672-4211
Requested package NDC
51672-4211-8
11-digit product format
516724211
Labeler code
51672
Product ID
51672-4211_92921d55-1976-4d38-8e19-5c1705f052b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
LOTION
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA210720
Marketing category
ANDA
Marketing start
2020-05-06
Marketing end
0000-00-00
Substance
IVERMECTIN
Active strength
5 mg/g
Pharmacologic classes
Antiparasitic [EPC],Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-421151672-4211-8DDiscontinued by firm2026-08-03

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
A210720-001IVERMECTINIVERMECTIN0.5%LOTION / TOPICAL2020-05-06

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 22:54:322026-06A210720-001IVERMECTIN0.5%LOTION / TOPICAL2020-05-06a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINAmerisourceBergen4e924212-cd7b-ccd9-e063-6394a90afb952026-04-16WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINSun Pharmaceutical Industries, Inc.dd2c66e6-bd50-46df-a335-26215d02d13b2025-12-22WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINCVS Pharmacy326e85c6-b95f-6aa8-e063-6294a90a49852025-06-20WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
RID One and DoneIVERMECTINOystershell Consumer Health, Inc.731a15f8-3578-4a95-b04c-aa6cf44a46652025-03-07WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINWALMART INC.1608ec4a-2af4-4a43-a83f-5b25937068d12025-01-09WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINBelmora LLC0d405318-3db5-41b6-a248-a6c1cfe7a7652024-10-17WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINRite Aid Corporation3a2eb7f3-b72b-435c-a609-ce7050cccff42024-08-12WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINWalgreen Companyb8e1d919-ba66-4dc0-b0fc-cfb3a229dad92022-01-04WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720
IvermectinIVERMECTINCVS Pharmacy15f1fe25-8ac4-486c-926d-86da187f5efc2021-12-30WarningsExact identifier
application applno (ANDA): 210720
application number: ANDA210720

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4211-8GM - Gram51672-4211f803a15e-1fab-4857-b332-a4461dfedf3e12021-01-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4211-8516724211081 TUBE in 1 CARTON (51672-4211-8) > 117 g in 1 TUBE1 tube2020-05-060000-00-00NoNoCurrent