Home NDC 51672-4145 Imiquimod
Product NDC 51672-4145
11-digit product format 516724145
Labeler code 51672
Product ID 51672-4145_3c178924-2055-ce8d-e063-6294a90a644f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA200173
Marketing category ANDA
Marketing start 2011-04-15
Substance IMIQUIMOD
Active strength 50 mg/g
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 A200173-001 IMIQUIMOD IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200173-001 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 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200173-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2011-04-15 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 50 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 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 51672-4145-6 Imiquimod 24 in 1 CARTON CREAM 24 11 51672-4145-8 Imiquimod 0.25 g in 1 PACKET CREAM 0.25 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Imiquimod ACTIVE INGREDIENT P1QW714R7M IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 Imiquimod ACTIVE MOIETY P1QW714R7M IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 glycerin INACTIVE INGREDIENT PDC6A3C0OX IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 isostearic acid INACTIVE INGREDIENT X33R8U0062 IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 methylparaben INACTIVE INGREDIENT A2I8C7HI9T IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 petrolatum INACTIVE INGREDIENT 4T6H12BN9U IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6 xanthan gum INACTIVE INGREDIENT TTV12P4NEE IMIQUIMOD CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4145 IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250406_59af8153-4cf8-4f22-9000-f239798d52d1.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 51672-4145-6 51672414506 24 PACKET in 1 CARTON (51672-4145-6) / .25 g in 1 PACKET (51672-4145-8) 24 packet 2011-04-15 0000-00-00 No No Current 51672-4145-8 51672414508 0.25 g in 1 PACKET 0.25 g Historical