FDA.reportPublic FDA data

Ivermectin

Product NDC
72888-207
11-digit product format
728880207
Labeler code
72888
Product ID
72888-207_2cda4d15-1149-28c0-e063-6294a90a8736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA215922
Marketing category
ANDA
Marketing start
2025-01-22
Substance
IVERMECTIN
Active strength
6 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215922-001IVERMECTINIVERMECTIN3MGTABLET / ORALAB2025-01-22
A215922-002IVERMECTINIVERMECTIN6MGTABLET / ORAL2025-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215922-001AB

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 22:54:322026-06A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22a50c72e98297…
2026-08-01 22:54:322026-06A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215922-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINAdvagen Pharma Ltde88adfbc-e375-4fea-827e-6ec51ed6fd0a2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215922
application number: ANDA215922
ndc (product): 72888-207

Additional Listing Data#

Finished product
Yes
Brand name base
Ivermectin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN6 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199998Internal RxNorm lookup
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
e88adfbc-e375-4fea-827e-6ec51ed6fd0aAvailable 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
72888-207-08Ivermectin10 in 1 BLISTER PACKTABLET101
72888-207-09Ivermectin10 in 1 CARTONTABLET101
72888-207-30Ivermectin30 in 1 BOTTLETABLET301
72888-207-66Ivermectin2 in 1 CARTONTABLET21
72888-207-66Ivermectin10 in 1 BLISTER PACKTABLET101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-207-08EA - Each72888-207c2334c31-ec40-4d6b-b718-b9d009117ad612025-05-14
72888-207-66EA - Each72888-2072fc86cbb-44f4-40a3-8443-c19b0f82a92a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-207IVERMECTIN TABLET [ADVAGEN PHARMA LTD]1Current NDC, 5 package rows20250130_e88adfbc-e375-4fea-827e-6ec51ed6fd0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSNe88adfbc-e375-4fea-827e-6ec51ed6fd0a1
199998ivermectin 6 MG Oral TabletPSNe88adfbc-e375-4fea-827e-6ec51ed6fd0a1
311207ivermectin 3 MG Oral TabletSCDe88adfbc-e375-4fea-827e-6ec51ed6fd0a1
199998ivermectin 6 MG Oral TabletSCDe88adfbc-e375-4fea-827e-6ec51ed6fd0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-207-087288802070810 in 1 BLISTER PACKHistorical
72888-207-097288802070910 BLISTER PACK in 1 CARTON (72888-207-09) / 10 TABLET in 1 BLISTER PACK (72888-207-08) 10 blister pack2025-01-22NoNoCurrent
72888-207-307288802073030 TABLET in 1 BOTTLE (72888-207-30) 30 tablet2025-01-22NoNoCurrent
72888-207-66728880207662 BLISTER PACK in 1 CARTON (72888-207-66) / 10 TABLET in 1 BLISTER PACK2 blister pack2025-01-22NoNoCurrent