Home NDC 74157-006-60 Amcinonide
Product NDC 74157-006
Requested package NDC 74157-006-60
11-digit product format 741570006
Labeler code 74157
Product ID 74157-006_395847bf-ef5e-ef2a-e063-6294a90acf3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amcinonide
Dosage form CREAM
Route TOPICAL
Labeler INA PHARMACEUTICS INC.
Application ANDA076229
Marketing category ANDA
Marketing start 2024-05-09
Substance AMCINONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A076229-001 AMCINONIDE AMCINONIDE 0.1% CREAM / TOPICAL RS 2002-05-31
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 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076229-001 AMCINONIDE 0.1% CREAM / TOPICAL AB 2002-05-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Amcinonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMCINONIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 423W026MA9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197327 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 74157-006-60 Amcinonide 60 g in 1 TUBE CREAM 60 3 74157-006-60 Amcinonide 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74157-006 AMCINONIDE CREAM [INA PHARMACEUTICS INC.] 2 Current NDC, 2 package rows 20240516_e7dc754e-eeff-4c30-a52a-629c72ad2415.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 Sample Exclude flag Status 74157-006-60 74157000660 1 TUBE in 1 CARTON (74157-006-60) / 60 g in 1 TUBE 1 tube 2024-05-09 No No Current