Home NDC 71335-3000 Imiquimod
Product NDC 71335-3000
11-digit product format 713353000
Labeler code 71335
Product ID 71335-3000_c37787b9-97c9-4b70-8fa7-847cebc2f0e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Bryant Ranch Prepack
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-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 RLD / RS 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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-3000-1 Imiquimod 0.25 g in 1 PACKET CREAM 0.25 100 71335-3000-1 Imiquimod 24 in 1 CARTON CREAM 24 100
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-3000-1 71335300001 24 PACKET in 1 CARTON (71335-3000-1) / .25 g in 1 PACKET 24 packet 2025-11-05 No No Current