Home NDC 51672-4174 Imiquimod
Product NDC 51672-4174
11-digit product format 516724174
Labeler code 51672
Product ID 51672-4174_48e9d045-e9a2-8452-e063-6294a90af1e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA205971
Marketing category ANDA
Marketing start 2021-01-26
Substance IMIQUIMOD
Active strength 37.5 mg/g
Pharmacologic classes Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A205971-001 IMIQUIMOD IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205971-001 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.
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 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Imiquimod
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMIQUIMOD 37.5 mg/g
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 967017 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 51672-4174-6 Imiquimod 28 in 1 CARTON CREAM 28 8 51672-4174-8 Imiquimod 0.25 g in 1 PACKET CREAM 0.25 8 51672-4174-9 Imiquimod 7.5 g in 1 BOTTLE, PUMP CREAM 7.5 8 51672-4174-9 Imiquimod 1 in 1 CARTON CREAM 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4174 IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20250406_51913a5a-1cab-4b9e-b2c2-e0174062df73.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4174-6 51672417406 28 PACKET in 1 CARTON (51672-4174-6) / .25 g in 1 PACKET (51672-4174-8) 28 packet 2021-01-26 0000-00-00 No No Current 51672-4174-8 51672417408 0.25 g in 1 PACKET 0.25 g Historical 51672-4174-9 51672417409 1 BOTTLE, PUMP in 1 CARTON (51672-4174-9) / 7.5 g in 1 BOTTLE, PUMP 2021-10-14 0000-00-00 No No Current