Triamcinolone Acetonide

Product NDC: 49999-216
Requested package NDC: 49999-216-15
11-digit product format: 499990216
Labeler code: 49999
Product ID: 49999-216_f8437d94-e23f-48e5-85a8-a19488083642
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA085691
Marketing category: ANDA
Marketing start: 1978-02-14
Marketing end: 2022-04-30
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49999-216	49999-216-15	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085691-001	AT	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-216-15	GM - Gram	49999-216	26052f0c-4ebb-4ef2-a754-6a1a187d875a	1	2016-12-07

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-216-15	49999021615	15 g in 1 TUBE (49999-216-15)	15 g	2003-03-26	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%	Lake Erie Medical DBA Quality Care Products LLC	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	3