Triamcinolone Acetonide

Product NDC: 49999-216
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49999-216		D	Discontinued by firm		2026-08-03
excluded package	package	49999-216	49999-216-15	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	49999-216		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-216	49999-216-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	49999-216		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-216	49999-216-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`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…`

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 · 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

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

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