Home NDC 33342-334-13 Triamcinolone acetonide
Product NDC 33342-334
Requested package NDC 33342-334-13
11-digit product format 333420334
Labeler code 33342
Product ID 33342-334_43481ee3-0419-44c9-93ab-4fab9baa9273
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone acetonide
Dosage form OINTMENT
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA216625
Marketing category ANDA
Marketing start 2023-08-18
Substance TRIAMCINOLONE ACETONIDE
Active strength .5 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 A216625-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216625-001 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.
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 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216625-001 TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL AT 2023-08-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Triamcinolone acetonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE .5 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 1090641 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 33342-334-13 Triamcinolone acetonide 430 g in 1 JAR OINTMENT 430 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-334 TRIAMCINOLONE ACETONIDE OINTMENT [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20240415_43481ee3-0419-44c9-93ab-4fab9baa9273.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 Sample Exclude flag Status 33342-334-13 33342033413 430 g in 1 JAR (33342-334-13) 430 g 2023-08-18 No No Current