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 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
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
2026-08-01 22:54:322026-06A210225-001IVERMECTIN1%CREAM / TOPICALAB2020-04-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210225-001AB1a50c72e98297…

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 · 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

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

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