Triamcinolone Acetonide

Product NDC: 76420-361
Requested package NDC: 76420-361-80
11-digit product format: 764200361
Labeler code: 76420
Product ID: 76420-361_4cabf2fc-6271-57c8-e063-6394a90a4436
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: ANDA085691
Marketing category: ANDA
Marketing start: 1978-02-14
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A085691-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982
A085691-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982
A085691-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A085691-001	AT
A085691-002	AT
A085691-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A085691-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085691-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085691-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085691-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085691-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-001	AT	1	`301d65b070ca…`

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: Triamcinolone Acetonide
Listing expiration: 2027-12-31

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
1085633	Internal RxNorm lookup
1085636	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
b20c22b2-9a74-4b71-9015-40838fd2d193	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	SPL version
76420-361-00	Triamcinolone Acetonide	454 g in 1 JAR	OINTMENT	454	2
76420-361-15	Triamcinolone Acetonide	15 g in 1 TUBE	OINTMENT	15	2
76420-361-80	Triamcinolone Acetonide	80 g in 1 TUBE	OINTMENT	80	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-361	TRIAMCINOLONE ACETONIDE OINTMENT [ASCLEMED USA, INC.]	1	Current NDC, 3 package rows	20250525_b20c22b2-9a74-4b71-9015-40838fd2d193.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
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	b20c22b2-9a74-4b71-9015-40838fd2d193	2026-03-10	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691 ndc (package): 76420-361-80 ndc (product): 76420-361 ndc11 (package): 76420036180
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	a5cc640f-c72d-49fa-b970-906c9ffd8629	2026-01-28	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ee274346-938b-4678-9146-486ca65bcba5	2024-01-15	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691

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
1085633	triamcinolone acetonide 0.025 % Topical Ointment	PSN	b20c22b2-9a74-4b71-9015-40838fd2d193	2
1085636	triamcinolone acetonide 0.1 % Topical Ointment	PSN	b20c22b2-9a74-4b71-9015-40838fd2d193	2
1085633	triamcinolone acetonide 0.00025 MG/MG Topical Ointment	SCD	b20c22b2-9a74-4b71-9015-40838fd2d193	2
1085636	triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	b20c22b2-9a74-4b71-9015-40838fd2d193	2
1085633	triamcinolone acetonide 0.025 % Topical Ointment	SY	b20c22b2-9a74-4b71-9015-40838fd2d193	2
1085636	triamcinolone acetonide 0.1 % Topical Ointment	SY	b20c22b2-9a74-4b71-9015-40838fd2d193	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-361-80	76420036180	80 g in 1 TUBE (76420-361-80)	80 g	2025-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	2