Home NDC 0168-0006 Triamcinolone Acetonide
Product NDC 0168-0006
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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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
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 0168-0006-16 00168000616 454 g in 1 JAR (0168-0006-16) 454 g 1978-02-14 0000-00-00 No No Current 0168-0006-80 00168000680 80 g in 1 TUBE (0168-0006-80) 80 g 1978-02-14 0000-00-00 No No Current