Home NDC 87519-004 Imiquimod
Product NDC 87519-004
11-digit product format 875190004
Labeler code 87519
Product ID 87519-004_5c19b6c9-81ef-c78d-e063-6394a90a2928
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Anvi Pharmaceuticals Inc.
Application ANDA205971
Marketing category ANDA
Marketing start 2026-09-01
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 43 .
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 2026-09-14 22:38:34 2026-08 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205971-001 IMIQUIMOD 3.75% CREAM / TOPICAL AB 2021-01-26 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Imiquimod IMIQUIMOD Sun Pharmaceutical Industries, Inc. 51913a5a-1cab-4b9e-b2c2-e0174062df73 2026-01-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205971 application number: ANDA205971
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 87519-004-75 87519000475 1 BOTTLE, PUMP in 1 CARTON (87519-004-75) / 7.5 g in 1 BOTTLE, PUMP 2026-09-01 No No Current