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 42.

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
2026-08-18 06:07:402026-07A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215922-001IVERMECTIN3MGTABLET / ORALAB2025-01-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215922-002IVERMECTIN6MGTABLET / ORAL2025-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215922-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215922-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215922-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215922-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215922-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215922-001AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215922-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215922-002CGT2025-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215922-002CGT2025-10-016a471c1ec25d…

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

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
IvermectinIVERMECTINAdvagen Pharma Ltde88adfbc-e375-4fea-827e-6ec51ed6fd0a2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215922
application number: ANDA215922
ndc (product): 72888-207

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