Home NDC 0168-0006-15 Triamcinolone Acetonide
Product NDC 0168-0006
Requested package NDC 0168-0006-15
11-digit product format 001680006
Labeler code 0168
Product ID 0168-0006_4ecf8bca-6585-4eed-88c7-c261a622d1cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamcinolone acetonide
Dosage form OINTMENT
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA085691
Marketing category ANDA
Marketing start 1978-02-14
Substance TRIAMCINOLONE ACETONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085691-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 A085691-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 A085691-003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 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 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085691-002 TRIAMCINOLONE ACETONIDE 0.5% OINTMENT / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085691-003 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085691-001 TRIAMCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT Approved before 1982 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1085633 Internal RxNorm lookup 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 0168-0006-15 Triamcinolone Acetonide 15 g in 1 TUBE OINTMENT 15 8 0168-0006-16 Triamcinolone Acetonide 454 g in 1 JAR OINTMENT 454 8 0168-0006-80 Triamcinolone Acetonide 80 g in 1 TUBE OINTMENT 80 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0006 TRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 3 package rows 20180426_a5cc640f-c72d-49fa-b970-906c9ffd8629.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 · 3 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 0168-0006-15 00168000615 15 g in 1 TUBE (0168-0006-15) 15 g 1978-02-14 0000-00-00 No No Current