Home NDC 55150-385 Triamcinolone Acetonide
Product NDC 55150-385
11-digit product format 551500385
Labeler code 55150
Product ID 55150-385_dab18c1a-6fc9-4427-b44f-e34e0168450e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRAMUSCULAR; SOFT TISSUE
Labeler Eugia US LLC
Application ANDA212400
Marketing category ANDA
Marketing start 2022-07-05
Substance TRIAMCINOLONE ACETONIDE
Active strength 40 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 A212400-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212400-001 AB
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 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212400-001 TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE / INJECTION AB 2022-07-05 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 40 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 1085754 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 55150-385-01 Triamcinolone Acetonide 1 in 1 CARTON INJECTION, SUSPENSION 1 4 55150-385-01 Triamcinolone Acetonide 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-385 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION [EUGIA US LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250504_d9abdda5-80e3-407c-b636-9cc5fc438098.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 Marketing start Marketing end Sample Exclude flag Status 55150-385-01 55150038501 1 VIAL, MULTI-DOSE in 1 CARTON (55150-385-01) / 10 mL in 1 VIAL, MULTI-DOSE 2022-07-05 0000-00-00 No No Current