Triamcinolone Acetonide

Product NDC: 42291-840
11-digit product format: 422910840
Labeler code: 42291
Product ID: 42291-840_9c9504a4-c69b-362b-e053-2a95a90a5715
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: PASTE
Route: TOPICAL
Labeler: AvKARE
Application: ANDA040771
Marketing category: ANDA
Marketing start: 2012-06-07
Marketing end: 0000-00-00
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-840		D	Discontinued by firm		2026-08-03
excluded package	package	42291-840	42291-840-05	D	Discontinued by firm		2026-08-03

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-840-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-840-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-840-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-840-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-840-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-840-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-840-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-840-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-840-05	`0efc9e666f02…`	`f202fb6c5f17…`
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	42291-840-05	`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	42291-840-05	`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	42291-840-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-840-05	GM - Gram	42291-840	73654032-d4d5-43e9-a035-147e0166d32a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIAMCINOLONE ACETONIDE	ACTIVE INGREDIENT	F446C597KA	TRIAMCINOLONE ACETONIDE PASTE [AVKARE, INC.]	3
Triamcinolone Acetonide	ACTIVE MOIETY	F446C597KA	TRIAMCINOLONE ACETONIDE PASTE [AVKARE, INC.]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TRIAMCINOLONE ACETONIDE PASTE [AVKARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRIAMCINOLONE ACETONIDE PASTE [AVKARE, INC.]	3
PECTIN, CITRUS	INACTIVE INGREDIENT	47EQO8LE7H	TRIAMCINOLONE ACETONIDE PASTE [AVKARE, INC.]	3

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
42291-840-05	42291084005	48 CARTON in 1 BOX (42291-840-05) > 1 TUBE in 1 CARTON > 5 g in 1 TUBE	48 carton	2012-06-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1% Rx only	AvKARE	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	7