Triamcinolone Acetonide

Product NDC: 68788-9172
11-digit product format: 687889172
Labeler code: 68788
Product ID: 68788-9172_d0c98629-0b7e-49b4-a7c9-67c8675fe0da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA086414
Marketing category: ANDA
Marketing start: 2008-06-10
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9172		D	Discontinued by firm	2026-08-03
excluded package	package	68788-9172	68788-9172-1	D	Discontinued by firm	2026-08-03
excluded package	package	68788-9172	68788-9172-8	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9172-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9172-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9172-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9172-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9172-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9172-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9172-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9172-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9172-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9172-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9172-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9172-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9172-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9172-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9172-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9172-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9172-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9172-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9172-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9172-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9172-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-9172-8	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9172-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-9172-8	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-9172-1	GM - Gram	68788-9172	77a45ca3-5bc7-43b5-8127-d83fe560ef76	1	2018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIAMCINOLONE ACETONIDE	ACTIVE INGREDIENT	F446C597KA	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
TRIAMCINOLONE ACETONIDE	ACTIVE MOIETY	F446C597KA	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2

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	NuCare Pharmaceuticals,Inc.	5439cd3c-da8d-3b96-e054-00144ff8d46c	2026-01-21	Adverse reactions	Exact identifier application applno (ANDA): 086414 application number: ANDA086414
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	696cd64f-28dd-3dae-e053-2a91aa0a0c76	2025-02-13	Adverse reactions	Exact identifier application applno (ANDA): 086414 application number: ANDA086414
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	4aa792cc-7cd4-4a98-8730-fa36feaa9b7a	2023-02-01	Adverse reactions	Exact identifier application applno (ANDA): 086414 application number: ANDA086414

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
68788-9172-1	68788917201	1 TUBE in 1 CARTON (68788-9172-1) > 15 g in 1 TUBE	1 tube	2008-06-10	0000-00-00	No	No	Current
68788-9172-8	68788917208	1 TUBE in 1 CARTON (68788-9172-8) > 80 g in 1 TUBE	1 tube	2008-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5%	Preferred Pharmaceuticals, Inc.	2023-01-10	HUMAN PRESCRIPTION DRUG LABEL	9