Home NDC 73308-407-60 Amcinonide
Product NDC 73308-407
Requested package NDC 73308-407-60
11-digit product format 733080407
Labeler code 73308
Product ID 73308-407_9e086586-6246-4f1f-a7c9-cd57a9a58617
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amcinonide
Dosage form OINTMENT
Route TOPICAL
Labeler Ayurax, LLC
Application ANDA076096
Marketing category ANDA
Marketing start 2023-05-01
Substance AMCINONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A076096-001 AMCINONIDE AMCINONIDE 0.1% OINTMENT / TOPICAL RS 2002-11-19
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 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL RS 2002-11-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL RS 2002-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL RS 2002-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL RS 2002-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076096-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB RS 2002-11-19 f41ea6bd6efb…
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 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 197328 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 73308-407-60 Amcinonide 60 g in 1 TUBE OINTMENT 60 3 73308-407-60 Amcinonide 1 in 1 CARTON OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73308-407 AMCINONIDE OINTMENT [AYURAX, LLC] 2 Current NDC, 2 package rows 20241003_83da75e7-e182-4a6c-ac0f-50d99971ebde.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73308-407-60 73308040760 1 TUBE in 1 CARTON (73308-407-60) / 60 g in 1 TUBE 1 tube 2023-05-01 No No Current