Home NDC 0168-0278-15 Amcinonide
Product NDC 0168-0278
Requested package NDC 0168-0278-15
11-digit product format 001680278
Labeler code 0168
Product ID 0168-0278_51093468-b64d-4b34-9627-8e6313c8265e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amcinonide
Dosage form CREAM
Route TOPICAL
Labeler Fougera Pharmaceuticals Inc.
Application ANDA076065
Marketing category ANDA
Marketing start 2003-05-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0168-0278 0168-0278-15 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0168-0278 0168-0278-15 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0168-0278 0168-0278-15 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…
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 A076065-001 AMCINONIDE AMCINONIDE 0.1% CREAM / TOPICAL 2003-05-15
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 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076065-001 AMCINONIDE 0.1% CREAM / TOPICAL AB RS 2003-05-15 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0278 AMCINONIDE CREAM [FOUGERA PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 6 package rows 20220702_8aefa477-ac2c-41c8-a807-d24522aed8f0.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 0168-0278-15 00168027815 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE 1 tube 2003-05-15 0000-00-00 No No Current