Home NDC 42571-385 Triamcinolone Acetonide
Product NDC 42571-385
11-digit product format 425710385
Labeler code 42571
Product ID 42571-385_2a47f154-f2ae-843e-e063-6394a90a6361
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamcinolone acetonide
Dosage form LOTION
Route TOPICAL
Labeler MICRO LABS LIMITED
Application ANDA040672
Marketing category ANDA
Marketing start 2021-08-16
Substance TRIAMCINOLONE ACETONIDE
Active strength 1 mg/mL
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 A040672-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040672-002 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 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040672-002 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 2006-12-13 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE 1 mg/mL
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 1085745 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 42571-385-19 Triamcinolone Acetonide 60 mL in 1 BOTTLE LOTION 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-385 TRIAMCINOLONE ACETONIDE LOTION [MICRO LABS LIMITED] 3 Current NDC, Legacy NDC, 1 package rows 20241228_22608943-79b1-4795-9231-ac4e166309d2.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 42571-385-19 42571038519 60 mL in 1 BOTTLE (42571-385-19) 60 ml 2021-08-16 0000-00-00 No No Current