triamcinolone acetonide

Product NDC: 51862-290
Requested package NDC: 51862-290-43
11-digit product format: 518620290
Labeler code: 51862
Product ID: 51862-290_bbcdfc0d-2b7c-4d9d-83cd-83ffbdc67786
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Mayne Pharma Inc.
Application: ANDA212384
Marketing category: ANDA
Marketing start: 2020-04-03
Marketing end: 0000-00-00
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	51862-290	51862-290-43	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 · 6 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…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-290-43	GM - Gram	51862-290	240be9f4-6110-4fa5-aaea-b9835e9a958b	1	2020-04-20

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

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
51862-290-43	51862029043	430 g in 1 JAR (51862-290-43)	430 g	2020-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide Ointment USP, 0.05%	Mayne Pharma Inc. \| Encube Ethicals Private Limited	2020-03-03	HUMAN PRESCRIPTION DRUG LABEL	1