KOURZEQ

Product NDC: 82682-001
Requested package NDC: 82682-001-05
11-digit product format: 826820001
Labeler code: 82682
Product ID: 82682-001_7aad2f23-85cb-4228-8460-aef6676cc11f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: PASTE
Route: TOPICAL
Labeler: MidAmerica Pharmaceuticals
Application: ANDA040771
Marketing category: ANDA
Marketing start: 2023-09-15
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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A040771-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2010-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040771-001	TRIAMCINOLONE ACETONIDE	0.1%	PASTE / DENTAL	AT	2010-07-01	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040771-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040771-001	AT	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: KOURZEQ
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085728	Internal RxNorm lookup
2665617	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
aad48d1e-f8db-4020-92af-0b3258bbc0f2	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
82682-001-05	KOURZEQ	1 in 1 CARTON	PASTE	1		7
82682-001-05	KOURZEQ	5 g in 1 TUBE	PASTE	5		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82682-001-05	GM - Gram	82682-001	59933c18-3e3d-4d4a-bb47-32c651e0d66a	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82682-001	KOURZEQ (TRIAMCINOLONE ACETONIDE) PASTE [MIDAMERICA PHARMACEUTICALS]	6	Current NDC, 2 package rows	20241019_aad48d1e-f8db-4020-92af-0b3258bbc0f2.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.

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 ndc (package): 82682-001-05 ndc (product): 82682-001 ndc11 (package): 82682000105
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2665617	kourzeq 0.1 % Oral Paste	PSN	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
1085728	triamcinolone acetonide 0.1 % Oral Paste	PSN	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
2665617	triamcinolone acetonide 0.001 MG/MG Oral Paste [Kourzeq]	SBD	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
1085728	triamcinolone acetonide 0.001 MG/MG Oral Paste	SCD	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
2665617	Kourzeq 0.1 % Oral Paste	SY	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
2665617	Kourzeq 1 MG per GM Dental Paste	SY	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
1085728	triamcinolone acetonide 0.1 % Dental Paste	SY	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7
1085728	triamcinolone acetonide 1 MG per GM Oral Paste	SY	aad48d1e-f8db-4020-92af-0b3258bbc0f2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82682-001-05	82682000105	1 TUBE in 1 CARTON (82682-001-05) / 5 g in 1 TUBE	1 tube	2023-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KOURZEQ™ (triamcinolone acetonide dental paste USP, 0.1%)	MidAmerica Pharmaceuticals \| Lyne Laboratories, Inc.	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	8