Imiquimod

Product NDC
45802-368
11-digit product format
458020368
Labeler code
45802
Product ID
45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078837
Marketing category
ANDA
Marketing start
2010-11-09
Substance
IMIQUIMOD
Active strength
12.5 mg/.25g
Pharmacologic classes
Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
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
A078837-001IMIQUIMODIMIQUIMOD5%CREAM / TOPICALAB2010-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078837-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-073f01610625f2…
2019-09-15 20:21 UTC2019-09A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078837-001IMIQUIMOD5%CREAM / TOPICALAB2010-09-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078837-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078837-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078837-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078837-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078837-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078837-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078837-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078837-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078837-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078837-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078837-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078837-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078837-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078837-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078837-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078837-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078837-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078837-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078837-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078837-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078837-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078837-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078837-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078837-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078837-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078837-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078837-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078837-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078837-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078837-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078837-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078837-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078837-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078837-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078837-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078837-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078837-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078837-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078837-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078837-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIQUIMOD12.5 mg/.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P1QW714R7MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1505cf54-37da-4b2b-9812-6ffd6a01a7c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5624e12d-8450-453b-aa8d-acacc0adf764Product name120210621
b519e8a5-29e1-d8cd-ace0-3915cc880d8fProduct name220150122
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-368-53Imiquimod0.25 g in 1 PACKETCREAM0.2513
45802-368-53Imiquimod12 in 1 CARTONCREAM1213
45802-368-62Imiquimod24 in 1 CARTONCREAM2413
45802-368-62Imiquimod0.25 g in 1 PACKETCREAM0.2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-368-53EA - Each45802-36885fa9135-afcc-4a39-9bec-2bc57c50beca12013-02-13
45802-368-62EA - Each45802-368ab255ea7-bdee-434a-ab15-10da04c8d39312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIQUIMODACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
IMIQUIMODACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-368IMIQUIMOD CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 4 package rows20250228_1505cf54-37da-4b2b-9812-6ffd6a01a7c7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ImiquimodIMIQUIMODBryant Ranch Prepack9291e5cd-b83d-4b43-88f5-30cac6cef5ff2025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078837
application number: ANDA078837
ImiquimodIMIQUIMODBryant Ranch Prepackf8db59e2-8052-413b-9f9f-07cd9eea07ec2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078837
application number: ANDA078837
ImiquimodIMIQUIMODBryant Ranch Prepack47d3045f-a145-4095-bb8a-c67ba1ff3bda2025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078837
application number: ANDA078837
ImiquimodIMIQUIMODPadagis Israel Pharmaceuticals Ltd1505cf54-37da-4b2b-9812-6ffd6a01a7c72025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078837
application number: ANDA078837
ndc (product): 45802-368
IMIQUIMODIMIQUIMODDIRECT RXa18a3f7e-7254-56c0-e053-2a95a90a70362025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078837
application number: ANDA078837

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310982imiquimod 5 % Topical CreamPSN47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 5 % Topical CreamPSN9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 50 MG/ML Topical CreamSCD47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 50 MG/ML Topical CreamSCD9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 5 % Topical CreamSY47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 5 % Topical CreamSY9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 5 % Topical CreamPSN1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 50 MG/ML Topical CreamSCD1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 5 % Topical CreamSY1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 5 % Topical CreamPSNf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 50 MG/ML Topical CreamSCDf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 5 % Topical CreamSYf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 5 % Topical CreamPSNa18a3f7e-7254-56c0-e053-2a95a90a70362
310982imiquimod 50 MG/ML Topical CreamSCDa18a3f7e-7254-56c0-e053-2a95a90a70362
310982imiquimod 5 % Topical CreamSYa18a3f7e-7254-56c0-e053-2a95a90a70362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-368-534580203685312 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET12 packet2012-07-120000-00-00NoNoCurrent
45802-368-624580203686224 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKET24 packet2010-11-090000-00-00NoNoCurrent