IMIQUIMOD

Product NDC: 72189-084
Requested package NDC: 72189-084-24
11-digit product format: 721890084
Labeler code: 72189
Product ID: 72189-084_2be84443-5bdd-96bd-e063-6294a90a9264
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IMIQUIMOD
Dosage form: CREAM
Route: TOPICAL
Labeler: DIRECT RX
Application: ANDA078837
Marketing category: ANDA
Marketing start: 2020-03-23
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-084	72189-084-24	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078837-001	IMIQUIMOD	IMIQUIMOD	5%	CREAM / TOPICAL	AB		2010-09-07

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078837-001	IMIQUIMOD	5%	CREAM / TOPICAL	AB	2010-09-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078837-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078837-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078837-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078837-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078837-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078837-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078837-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078837-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078837-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078837-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078837-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078837-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078837-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078837-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078837-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078837-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078837-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078837-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078837-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078837-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078837-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078837-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078837-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078837-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078837-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078837-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078837-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078837-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078837-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078837-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078837-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078837-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078837-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078837-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078837-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078837-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078837-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078837-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078837-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078837-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIQUIMOD	12.5 mg/.25g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P1QW714R7M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a18a3f7e-7254-56c0-e053-2a95a90a7036	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5624e12d-8450-453b-aa8d-acacc0adf764	Product name	1	20210621
b519e8a5-29e1-d8cd-ace0-3915cc880d8f	Product name	2	20150122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-084-24	IMIQUIMOD	0.25 g in 1 PACKET	CREAM	0.25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-084-24	EA - Each	72189-084	363e7ccd-c85b-4637-9420-6fb0375d83cc	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-084	IMIQUIMOD CREAM [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250119_a18a3f7e-7254-56c0-e053-2a95a90a7036.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	9291e5cd-b83d-4b43-88f5-30cac6cef5ff	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	f8db59e2-8052-413b-9f9f-07cd9eea07ec	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Bryant Ranch Prepack	47d3045f-a145-4095-bb8a-c67ba1ff3bda	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
Imiquimod	IMIQUIMOD	Padagis Israel Pharmaceuticals Ltd	1505cf54-37da-4b2b-9812-6ffd6a01a7c7	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837
IMIQUIMOD	IMIQUIMOD	DIRECT RX	a18a3f7e-7254-56c0-e053-2a95a90a7036	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078837 application number: ANDA078837 ndc (package): 72189-084-24 ndc (product): 72189-084 ndc11 (package): 72189008424

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P1QW714R7M	IMIQUIMOD	99011-02-6	IMIQUIMOD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310982	imiquimod 5 % Topical Cream	PSN	a18a3f7e-7254-56c0-e053-2a95a90a7036	2
310982	imiquimod 50 MG/ML Topical Cream	SCD	a18a3f7e-7254-56c0-e053-2a95a90a7036	2
310982	imiquimod 5 % Topical Cream	SY	a18a3f7e-7254-56c0-e053-2a95a90a7036	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-084-24	72189008424	.25 g in 1 PACKET (72189-084-24)	2020-03-23	0000-00-00	No	No	Current