Triamcinolone Acetonide

Product NDC: 68071-1623
Requested package NDC: 68071-1623-1
11-digit product format: 680711623
Labeler code: 68071
Product ID: 68071-1623_d6ac585b-1591-af65-e053-2995a90a15ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: PASTE
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040771
Marketing category: ANDA
Marketing start: 2010-07-07
Marketing end: 0000-00-00
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-1623	68071-1623-1	D	Discontinued by firm		2026-08-07

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040771-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040771-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040771-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040771-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040771-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040771-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040771-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040771-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040771-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040771-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040771-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040771-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040771-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040771-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040771-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040771-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040771-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040771-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040771-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040771-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040771-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040771-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040771-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040771-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040771-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040771-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040771-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040771-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040771-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040771-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040771-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040771-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040771-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040771-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040771-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040771-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040771-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040771-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040771-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040771-001	AT	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1623-1	2022-01-30	C162847	48780-1	d6a99b39-ed21-a426-e053-dadaa90af4c2	TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%
68071-1623-1	2022-01-28	C162847	48780-1	d6a99b39-ed21-a426-e053-dadaa90af4c2	TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KOURZEQ	TRIAMCINOLONE ACETONIDE	MidAmerica Pharmaceuticals	aad48d1e-f8db-4020-92af-0b3258bbc0f2	2025-11-18	Adverse reactions	Exact identifier application applno (ANDA): 040771 application number: ANDA040771
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals, Inc.	a1633e66-2ce8-42e4-8046-ac10dadfa34b	2025-10-01	Adverse reactions	Exact identifier application applno (ANDA): 040771 application number: ANDA040771
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Rising Pharma Holdings, Inc.	15ab1090-47d1-4925-8362-d7dda6fe74a9	2025-04-11	Adverse reactions	Exact identifier application applno (ANDA): 040771 application number: ANDA040771

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F446C597KA	TRIAMCINOLONE ACETONIDE	76-25-5	TRIAMCINOLONE ACETONIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1623-1	68071162301	5 g in 1 BOX (68071-1623-1)	5 g	2017-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%	NuCare Pharmaceuticals,Inc.	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	3