Triamcinolone Acetonide

Product NDC: 0713-0655
11-digit product format: 007130655
Labeler code: 0713
Product ID: 0713-0655_ee9c5cfd-2bcc-eee9-e053-2a95a90aeef9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: PASTE
Route: DENTAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: ANDA205592
Marketing category: ANDA
Marketing start: 2017-01-13
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
A205592-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT		2017-01-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205592-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A205592-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2017-01-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A205592-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205592-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205592-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205592-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205592-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205592-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205592-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205592-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205592-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205592-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205592-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205592-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205592-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205592-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205592-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205592-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205592-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205592-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205592-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205592-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205592-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205592-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205592-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205592-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205592-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205592-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205592-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205592-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205592-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205592-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205592-001	AT	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A205592-001	AT	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	da5652f8-585c-4697-bc65-2a613cb0ef0f	2025-03-20	Adverse reactions	Exact identifier application applno (ANDA): 205592 application number: ANDA205592
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	d2095a36-3fcf-7c20-95e5-e046b014565f	2022-11-29	Adverse reactions	Exact identifier application applno (ANDA): 205592 application number: ANDA205592 ndc (product): 0713-0655

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
1085728	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d2095a36-3fcf-7c20-95e5-e046b014565f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
75f7e47b-8736-a182-fc44-22aca8d79689	Product name	2	20251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2	Product name	6	20250516
e42f429b-c4e5-0402-e1c5-730154df4060	Product name	4	20240205
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
089e0644-1ea8-8654-4113-39f960dd57d5	Product name	3	20210115
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
9f64e0dc-109c-9660-8e0e-91ec987b3817	Product name	6	20171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002f	Product name	1	20171204
8de20f81-8411-4cf1-a8b2-03404ee56d01	Product name	3	20171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8	Product name	2	20160819
355b2224-0895-7135-83f5-d099a6a82a0a	Product name	1	20140508
55be6b50-8cc0-f0f1-74a1-3416a91193aa	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0713-0655-40	Triamcinolone Acetonide	1 in 1 CARTON	PASTE	1		4
0713-0655-40	Triamcinolone Acetonide	5 g in 1 TUBE	PASTE	5		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0655-40	GM - Gram	0713-0655	b64369f2-5efb-4e10-bced-d5f1bb93698a	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0655	TRIAMCINOLONE ACETONIDE PASTE [COSETTE PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20221130_d2095a36-3fcf-7c20-95e5-e046b014565f.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1085728	triamcinolone acetonide 0.1 % Oral Paste	PSN	d2095a36-3fcf-7c20-95e5-e046b014565f	4
1085728	triamcinolone acetonide 0.001 MG/MG Oral Paste	SCD	d2095a36-3fcf-7c20-95e5-e046b014565f	4
1085728	triamcinolone acetonide 0.1 % Dental Paste	SY	d2095a36-3fcf-7c20-95e5-e046b014565f	4
1085728	triamcinolone acetonide 1 MG per GM Oral Paste	SY	d2095a36-3fcf-7c20-95e5-e046b014565f	4
1085728	triamcinolone acetonide 0.1 % Oral Paste	PSN	da5652f8-585c-4697-bc65-2a613cb0ef0f	1
1085728	triamcinolone acetonide 0.001 MG/MG Oral Paste	SCD	da5652f8-585c-4697-bc65-2a613cb0ef0f	1
1085728	triamcinolone acetonide 0.1 % Dental Paste	SY	da5652f8-585c-4697-bc65-2a613cb0ef0f	1
1085728	triamcinolone acetonide 1 MG per GM Oral Paste	SY	da5652f8-585c-4697-bc65-2a613cb0ef0f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0713-0655-40	00713065540	1 TUBE in 1 CARTON (0713-0655-40) / 5 g in 1 TUBE	1 tube	2017-01-13	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	Preferred Pharmaceuticals Inc.	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
TRIAMCINOLONE ACETONIDE DENTAL PASTE, USP 0.1% Rx only	Cosette Pharmaceuticals, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2022-11-29	HUMAN PRESCRIPTION DRUG LABEL	4
TRIAMCINOLONE ACETONIDE DENTAL PASTE, USP 0.1% Rx only	Preferred Pharmaceuticals Inc.	2020-10-07	HUMAN PRESCRIPTION DRUG LABEL	3
TRIAMCINOLONE ACETONIDE DENTAL PASTE, USP 0.1% Rx only	NuCare Pharmaceuticals,Inc.	2019-05-09	HUMAN PRESCRIPTION DRUG LABEL	3