Triamcinolone Acetonide

Product NDC: 72603-319
11-digit product format: 726030319
Labeler code: 72603
Product ID: 72603-319_fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide Ointment USP, 0.05%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Northstar Rx LLC
Application: ANDA212384
Marketing category: ANDA
Marketing start: 2024-11-01
Substance: TRIAMCINOLONE ACETONIDE
Active strength: .5 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
A212384-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212384-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT		2019-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212384-001	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT / TOPICAL	AT	RS	2019-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212384-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212384-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212384-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212384-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212384-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212384-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212384-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212384-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212384-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212384-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212384-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212384-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212384-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212384-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212384-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212384-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212384-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212384-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212384-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212384-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212384-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212384-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	AT	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212384-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212384-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212384-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212384-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212384-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212384-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212384-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212384-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212384-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212384-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212384-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212384-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212384-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212384-001	AT	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212384-001	CGT	2020-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212384-001	CGT	2020-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212384-001	CGT	2020-05-30	`3f01610625f2…`

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	.5 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
1090641	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
fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	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
72603-319-01	Triamcinolone Acetonide	430 g in 1 JAR	OINTMENT	430		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-319-01	GM - Gram	72603-319	f84cfb6b-1614-4b43-84d7-4d5fc36fc88a	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-319	TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%) OINTMENT [NORTHSTAR RX LLC]	1	Current NDC, 1 package rows	20241102_fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%	Encube Ethicals, Inc.	a20baaac-002d-40ac-9c7b-f92e8ee987ea	2025-09-25	Adverse reactions	Exact identifier application applno (ANDA): 212384 application number: ANDA212384
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%	Northstar Rx LLC	fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	2024-09-03	Adverse reactions	Exact identifier application applno (ANDA): 212384 application number: ANDA212384 ndc (product): 72603-319

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
1090641	triamcinolone acetonide 0.05 % Topical Ointment	PSN	fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	1
1090641	triamcinolone acetonide 0.0005 MG/MG Topical Ointment	SCD	fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	1
1090641	triamcinolone acetonide 0.05 % Topical Ointment	SY	fb7c85fa-56f1-4cb1-821d-0f6c9adc83f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-319-01	72603031901	430 g in 1 JAR (72603-319-01)	430 g	2024-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx only	Northstar Rx LLC \| Encube Ethicals Private Limited	2024-09-03	Human Prescription Drug Label	1