Imiquimod

Product NDC
63629-8818
11-digit product format
636298818
Labeler code
63629
Product ID
63629-8818_55582461-cd3d-4554-8996-c6b84cfd2250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
NDA022483
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-07-30
Marketing end
0000-00-00
Substance
IMIQUIMOD
Active strength
38 mg/g
Pharmacologic classes
Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8818DDiscontinued by firm2026-08-03
excluded packagepackage63629-881863629-8818-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022483-001ZYCLARAIMIQUIMOD3.75%CREAM / TOPICALABRLD, RS2010-03-25
N022483-002ZYCLARAIMIQUIMOD2.5%CREAM / TOPICALRLD, RS2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022483-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022483-001102386452029-08-18U-14552019-04-11
N022483-001102386452029-08-18U-1722019-04-11
N022483-00185981962029-08-18U-14552013-12-11
N022483-00185981962029-08-18U-1722013-12-11
N022483-001102386442029-12-11U-682019-04-11
N022483-00182368162029-12-11U-682012-08-08
N022483-00182991092029-12-11U-682012-11-01
N022483-001109186352030-04-30U-14552021-03-03
N022483-001109186352030-04-30U-1722021-03-03
N022483-001112027522030-04-30U-14552022-01-19
N022483-001112027522030-04-30U-1722022-01-19
N022483-001118502452030-04-30U-14552024-01-12
N022483-001118502452030-04-30U-1722024-01-12
N022483-002113181302029-12-11U-682022-05-20
N022483-00282222702029-12-11U-682012-07-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022483-001ZYCLARA3.75%CREAM / TOPICALRLD, RS2010-03-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022483-001ZYCLARA3.75%CREAM / TOPICALABRLD, RS2010-03-25782e0a99824c…
2021-12-28 21:50 UTC2021-12N022483-002ZYCLARA2.5%CREAM / TOPICALRLD, RS2011-07-15782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022483-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022483-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022483-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022483-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022483-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022483-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022483-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022483-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022483-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022483-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022483-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022483-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022483-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022483-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022483-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022483-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022483-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022483-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022483-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022483-001AB15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022483-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022483-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022483-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022483-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022483-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022483-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022483-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022483-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022483-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022483-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022483-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022483-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022483-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022483-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 14 · 523 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022483-001102386452029-08-18U-1722019-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001102386452029-08-18U-14552019-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-00185981962029-08-18U-1722013-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-00185981962029-08-18U-14552013-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001102386442029-12-11U-682019-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-00182368162029-12-11U-682012-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-00182991092029-12-11U-682012-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001109186352030-04-30U-1722021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001109186352030-04-30U-14552021-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001112027522030-04-30U-14552022-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001112027522030-04-30U-1722022-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001118502452030-04-30U-14552024-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-001118502452030-04-30U-1722024-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-002113181302029-12-11U-682022-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022483-00282222702029-12-11U-682012-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001102386452029-08-18U-1722019-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001102386452029-08-18U-14552019-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-00185981962029-08-18U-1722013-12-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-00185981962029-08-18U-14552013-12-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001102386442029-12-11U-682019-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-00182368162029-12-11U-682012-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-00182991092029-12-11U-682012-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001109186352030-04-30U-1722021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001109186352030-04-30U-14552021-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001112027522030-04-30U-14552022-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001112027522030-04-30U-1722022-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001118502452030-04-30U-14552024-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-001118502452030-04-30U-1722024-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-002113181302029-12-11U-682022-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022483-00282222702029-12-11U-682012-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022483-001102386452029-08-18U-1722019-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-001102386452029-08-18U-14552019-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-00185981962029-08-18U-1722013-12-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-00185981962029-08-18U-14552013-12-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-001102386442029-12-11U-682019-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-00182368162029-12-11U-682012-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-00182991092029-12-11U-682012-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-001109186352030-04-30U-1722021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-001109186352030-04-30U-14552021-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022483-001112027522030-04-30U-14552022-01-196a471c1ec25d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8818-1GM - Gram63629-88182617504e-5de1-4067-ba62-bfc99558181e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8818IMIQUIMOD CREAM [BRYANT RANCH PREPACK]102Legacy NDC20240113_1de49a4d-dc7e-48ff-b18c-e1414282fe71.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
ImiquimodIMIQUIMODTeva Pharmaceuticals USA, Inc.9f2cbefd-f295-47e2-8a9e-3e7c5812c9632025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 022483
application number: NDA022483
ImiquimodIMIQUIMODOceanside Pharmacueticalsd86eeb0e-70e0-4c72-aaa3-37daa1d8611e2025-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 022483
application number: NDA022483
ZyclaraIMIQUIMODBausch Health US, LLC28cd9b5b-680b-480f-b33d-9c5b52bbf03d2025-05-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 022483
application number: NDA022483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8818-1636298818011 BOTTLE, PUMP in 1 CARTON (63629-8818-1) > 7.5 g in 1 BOTTLE, PUMP2021-09-100000-00-00NoNoCurrent