Home NDC 63629-8818-1 Imiquimod
Product NDC 63629-8818
Requested package NDC 63629-8818-1
11-digit product format 636298818
Labeler code 63629
Product ID 63629-8818_55582461-cd3d-4554-8996-c6b84cfd2250
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Bryant Ranch Prepack
Application NDA022483
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-07-30
Marketing end 0000-00-00
Substance IMIQUIMOD
Active strength 38 mg/g
Pharmacologic classes Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022483-001 ZYCLARA IMIQUIMOD 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 N022483-002 ZYCLARA IMIQUIMOD 2.5% CREAM / TOPICAL RLD, RS 2011-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022483-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
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 3 · 82 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 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL RLD, RS 2010-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022483-001 ZYCLARA 3.75% CREAM / TOPICAL AB RLD, RS 2010-03-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022483-002 ZYCLARA 2.5% CREAM / TOPICAL RLD, RS 2011-07-15 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 14 · 523 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022483-001 10238645 2029-08-18 U-172 2019-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 10238645 2029-08-18 U-1455 2019-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 8598196 2029-08-18 U-172 2013-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 8598196 2029-08-18 U-1455 2013-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 10238644 2029-12-11 U-68 2019-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 8236816 2029-12-11 U-68 2012-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 8299109 2029-12-11 U-68 2012-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 10918635 2030-04-30 U-172 2021-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 10918635 2030-04-30 U-1455 2021-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 11202752 2030-04-30 U-1455 2022-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 11202752 2030-04-30 U-172 2022-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 11850245 2030-04-30 U-1455 2024-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-001 11850245 2030-04-30 U-172 2024-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-002 11318130 2029-12-11 U-68 2022-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022483-002 8222270 2029-12-11 U-68 2012-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 10238645 2029-08-18 U-172 2019-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 10238645 2029-08-18 U-1455 2019-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 8598196 2029-08-18 U-172 2013-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 8598196 2029-08-18 U-1455 2013-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 10238644 2029-12-11 U-68 2019-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 8236816 2029-12-11 U-68 2012-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 8299109 2029-12-11 U-68 2012-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 10918635 2030-04-30 U-172 2021-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 10918635 2030-04-30 U-1455 2021-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 11202752 2030-04-30 U-1455 2022-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 11202752 2030-04-30 U-172 2022-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 11850245 2030-04-30 U-1455 2024-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-001 11850245 2030-04-30 U-172 2024-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-002 11318130 2029-12-11 U-68 2022-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022483-002 8222270 2029-12-11 U-68 2012-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022483-001 10238645 2029-08-18 U-172 2019-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 10238645 2029-08-18 U-1455 2019-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 8598196 2029-08-18 U-172 2013-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 8598196 2029-08-18 U-1455 2013-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 10238644 2029-12-11 U-68 2019-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 8236816 2029-12-11 U-68 2012-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 8299109 2029-12-11 U-68 2012-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 10918635 2030-04-30 U-172 2021-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 10918635 2030-04-30 U-1455 2021-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022483-001 11202752 2030-04-30 U-1455 2022-01-19 6a471c1ec25d…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8818 IMIQUIMOD CREAM [BRYANT RANCH PREPACK] 102 Legacy NDC 20240113_1de49a4d-dc7e-48ff-b18c-e1414282fe71.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-8818-1 63629881801 1 BOTTLE, PUMP in 1 CARTON (63629-8818-1) > 7.5 g in 1 BOTTLE, PUMP 2021-09-10 0000-00-00 No No Current