Ivermectin

Product NDC
27241-293
11-digit product format
272410293
Labeler code
27241
Product ID
27241-293_3a1375c9-01f7-4ff7-8208-5a7baf4de267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218509
Marketing category
ANDA
Marketing start
2026-04-07
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 42.

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
A218509-001IVERMECTINIVERMECTIN3MGTABLET / ORALAB2026-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218509-001AB

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
2026-08-18 06:07:402026-07A218509-001IVERMECTIN3MGTABLET / ORALAB2026-04-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218509-001IVERMECTIN3MGTABLET / ORALAB2026-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218509-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218509-001AB1a50c72e98297…

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
1fb17bc2-9192-4a0b-a3ee-fda9db035daaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-293-73Ivermectin10 in 1 BLISTER PACKTABLET103
27241-293-73Ivermectin2 in 1 CARTONTABLET23

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINAjanta Pharma USA Inc.1fb17bc2-9192-4a0b-a3ee-fda9db035daa2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218509
application number: ANDA218509
ndc (product): 27241-293

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311207ivermectin 3 MG Oral TabletPSN1fb17bc2-9192-4a0b-a3ee-fda9db035daa3
311207ivermectin 3 MG Oral TabletSCD1fb17bc2-9192-4a0b-a3ee-fda9db035daa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-293-73272410293732 BLISTER PACK in 1 CARTON (27241-293-73) / 10 TABLET in 1 BLISTER PACK2 blister pack2026-04-07NoNoCurrent