Ivermectin

Product NDC
72162-2294
11-digit product format
721622294
Labeler code
72162
Product ID
72162-2294_3b7b662b-8390-4168-b31e-ba430febc1a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivermectin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA210225
Marketing category
ANDA
Marketing start
2024-01-08
Substance
IVERMECTIN
Active strength
10 mg/g
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210225-001IVERMECTINIVERMECTIN1%CREAM / TOPICALAB2020-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210225-001AB

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 06:07:402026-07A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-134b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210225-001IVERMECTIN1%CREAM / TOPICAL2020-04-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210225-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210225-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210225-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210225-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210225-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210225-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210225-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210225-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210225-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210225-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210225-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210225-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210225-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210225-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210225-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210225-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210225-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210225-001AB1ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210225-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN10 mg/g

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
1598068Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75973e89-a03f-48dd-8fe8-8eafc1938d09Available 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
72162-2294-2Ivermectin45 g in 1 TUBECREAM452
72162-2294-2Ivermectin1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2294-2GM - Gram72162-229447b51b2a-c582-49d5-8744-4c34053cfc6d12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2294IVERMECTIN CREAM [BRYANT RANCH PREPACK]2Current NDC, 2 package rows20250315_75973e89-a03f-48dd-8fe8-8eafc1938d09.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvermectinIVERMECTINBryant Ranch Prepack1061e454-d1dc-4293-b18d-9c8717fbbb402025-10-23Adverse reactionsExact identifier
application applno (ANDA): 210225
application number: ANDA210225
IvermectinIVERMECTINBryant Ranch Prepack75973e89-a03f-48dd-8fe8-8eafc1938d092024-04-30Adverse reactionsExact identifier
application applno (ANDA): 210225
application number: ANDA210225
ndc (product): 72162-2294
IvermectinIVERMECTINPadagis Israel Pharmaceuticals Ltd1d3e7aea-02a4-46b1-8a14-0324e4777cb42024-03-31Adverse reactionsExact identifier
application applno (ANDA): 210225
application number: ANDA210225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSN75973e89-a03f-48dd-8fe8-8eafc1938d092
1598068ivermectin 10 MG/ML Topical CreamSCD75973e89-a03f-48dd-8fe8-8eafc1938d092
1598068ivermectin 1 % Topical CreamSY75973e89-a03f-48dd-8fe8-8eafc1938d092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2294-2721622294021 TUBE in 1 CARTON (72162-2294-2) / 45 g in 1 TUBE1 tube2024-04-30NoNoCurrent