Home NDC 68071-4383 Triamcinolone Acetonide
Product NDC 68071-4383
11-digit product format 680714383
Labeler code 68071
Product ID 68071-4383_2e0ba60d-c2ea-f693-e063-6394a90a2e7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA086414
Marketing category ANDA
Marketing start 2006-09-28
Substance TRIAMCINOLONE ACETONIDE
Active strength 1 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-4383-5 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-4383-5 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-4383-5 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4383-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4383-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4383-5 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog .
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/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 1014314 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-01-08 Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% 2023-01-30 Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% 2021-02-16 Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% 2021-01-29 Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5%
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4383-5 Triamcinolone Acetonide 15 g in 1 BOX CREAM 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4383 TRIAMCINOLONE ACETONIDE CREAM [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250215_696cd64f-28dd-3dae-e053-2a91aa0a0c76.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 68071-4383-5 68071438305 15 g in 1 BOX (68071-4383-5) 15 g 2018-04-09 0000-00-00 No No Current