Home NDC 64980-320-05 Triamcinolone Acetonide
Product NDC 64980-320
Requested package NDC 64980-320-05
11-digit product format 649800320
Labeler code 64980
Product ID 64980-320_f567d65e-64c7-4de9-b907-4b625da75834
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form PASTE
Route TOPICAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA040771
Marketing category ANDA
Marketing start 2010-07-07
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 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 A040771-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040771-001 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 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040771-001 TRIAMCINOLONE ACETONIDE 0.1% PASTE / DENTAL AT 2010-07-01 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/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 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 64980-320-05 Triamcinolone Acetonide 48 in 1 BOX PASTE 48 10 64980-320-05 Triamcinolone Acetonide 1 in 1 CARTON PASTE 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-320 TRIAMCINOLONE ACETONIDE PASTE [RISING PHARMA HOLDINGS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250413_15ab1090-47d1-4925-8362-d7dda6fe74a9.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-320-05 64980032005 48 CARTON in 1 BOX (64980-320-05) / 1 TUBE in 1 CARTON / 5 g in 1 TUBE 48 carton 2010-07-07 0000-00-00 No No Current