Home NDC 51672-4054-3 Amcinonide
Product NDC 51672-4054
Requested package NDC 51672-4054-3
11-digit product format 516724054
Labeler code 51672
Product ID 51672-4054_815f3d2c-6fce-47b8-94c5-55295655cd1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amcinonide
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA076229
Marketing category ANDA
Marketing start 2002-05-31
Marketing end 0000-00-00
Substance AMCINONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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# DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amcinonide ACTIVE INGREDIENT 423W026MA9 AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 Amcinonide ACTIVE MOIETY 423W026MA9 AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 lactic acid INACTIVE INGREDIENT 33X04XA5AT AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbitol INACTIVE INGREDIENT 506T60A25R AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4054 AMCINONIDE CREAM AMCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 5 Legacy NDC, 8 package rows 20250406_ac5c3e79-52f7-434e-92ae-24bd32b45edc.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 · 2 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 51672-4054-3 51672405403 1 TUBE in 1 CARTON (51672-4054-3) > 60 g in 1 TUBE 1 tube 2002-05-31 0000-00-00 No No Current