Home NDC 21922-063-15 TRIAMCINOLONE ACETONIDE
Product NDC 21922-063
Requested package NDC 21922-063-15
11-digit product format 219220063
Labeler code 21922
Product ID 21922-063_582aa542-a36c-4e10-9966-23632122719c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form OINTMENT
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA205373
Marketing category ANDA
Marketing start 2023-08-01
Substance TRIAMCINOLONE ACETONIDE
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 A205373-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205373-001 AT
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 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205373-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 2016-05-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TRIAMCINOLONE ACETONIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F446C597KA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1085636 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 21922-063-04 TRIAMCINOLONE ACETONIDE 1 in 1 CARTON OINTMENT 1 3 21922-063-04 TRIAMCINOLONE ACETONIDE 15 g in 1 TUBE OINTMENT 15 3 21922-063-05 TRIAMCINOLONE ACETONIDE 1 in 1 CARTON OINTMENT 1 3 21922-063-05 TRIAMCINOLONE ACETONIDE 30 g in 1 TUBE OINTMENT 30 3 21922-063-15 TRIAMCINOLONE ACETONIDE 80 g in 1 TUBE OINTMENT 80 3 21922-063-15 TRIAMCINOLONE ACETONIDE 1 in 1 CARTON OINTMENT 1 3 21922-063-30 TRIAMCINOLONE ACETONIDE 454 g in 1 JAR OINTMENT 454 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-063 TRIAMCINOLONE ACETONIDE OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 7 package rows 20230803_6a31a0c3-2b6e-40e3-b5ea-5c665afd3567.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 Sample Exclude flag Status 21922-063-15 21922006315 1 TUBE in 1 CARTON (21922-063-15) / 80 g in 1 TUBE 1 tube 2023-08-01 No No Current