Home NDC 68462-536 Imiquimod
Product NDC 68462-536
11-digit product format 684620536
Labeler code 68462
Product ID 68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA201994
Marketing category ANDA
Marketing start 2012-03-06
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 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 A201994-001 IMIQUIMOD IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201994-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB RS 2012-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201994-001 IMIQUIMOD 5% CREAM / TOPICAL AB 2012-03-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imiquimod
Listing expiration 2027-12-31 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 68462-536-01 Imiquimod 0.25 g in 1 PACKET CREAM 0.25 12 68462-536-70 Imiquimod 24 in 1 CARTON CREAM 24 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IMIQUIMOD ACTIVE INGREDIENT P1QW714R7M IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 IMIQUIMOD ACTIVE MOIETY P1QW714R7M IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 ISOSTEARIC ACID INACTIVE INGREDIENT X33R8U0062 IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 WATER INACTIVE INGREDIENT 059QF0KO0R IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-536 IMIQUIMOD CREAM [GLENMARK PHARMACEUTICALS INC., USA] 11 Current NDC, Legacy NDC, 2 package rows 20240104_663e39a9-a29e-473f-89ec-4c7c6bc27b8a.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 68462-536-01 68462053601 0.25 g in 1 PACKET 0.25 g Historical 68462-536-70 68462053670 24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01) 24 packet 2012-03-06 0000-00-00 No No Current