Home NDC 51672-4060-3 Amcinonide
Product NDC 51672-4060
Requested package NDC 51672-4060-3
11-digit product format 516724060
Labeler code 51672
Product ID 51672-4060_31e404cb-aac7-730b-e063-6394a90afc03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amcinonide
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076367
Marketing category ANDA
Marketing start 2003-03-19
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 A076367-001 AMCINONIDE AMCINONIDE 0.1% OINTMENT / TOPICAL 2003-03-19
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 · 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 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL 2003-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL 2003-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076367-001 AMCINONIDE 0.1% OINTMENT / TOPICAL AB 2003-03-19 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197327 Internal RxNorm lookup 197328 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 51672-4060 AMCINONIDE CREAM AMCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 5 Current NDC, Legacy NDC, 6 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 · 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 51672-4060-3 51672406003 1 TUBE in 1 CARTON (51672-4060-3) / 60 g in 1 TUBE 1 tube 2003-03-19 0000-00-00 No No Current