TRIAMCINOLONE ACETONIDE

Product NDC: 67296-2346
11-digit product format: 672962346
Labeler code: 67296
Product ID: 67296-2346_5e428aa5-6f10-4ee4-e063-6394a90a0274
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA208848
Marketing category: ANDA
Marketing start: 2024-03-16
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 44.

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
A208848-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT		2017-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208848-001	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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A208848-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208848-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208848-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208848-001	AT	1	`a50c72e98297…`

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

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Encube Ethicals, Inc.	db87426f-124c-4ea9-bb15-fc3a0da10a4e	2026-07-07	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Direct_rx	4e400049-c763-56f7-e063-6294a90a6fd7	2026-03-30	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	60973042-077c-4265-988c-ad381f560333	2026-01-19	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	c6e46d6f-c64d-4242-a56f-8aff96e68993	2024-10-01	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	200bb913-a6ac-5a6b-e063-6294a90a161a	2024-08-19	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	69aec845-3d4a-d226-e053-2991aa0afd12	2024-06-10	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848

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	Sample	Exclude flag	Status
67296-2346-1	67296234601	1 TUBE in 1 CARTON (67296-2346-1) / 15 g in 1 TUBE	1 tube	2024-03-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% Rx only	Redpharm Drug	2026-10-20	HUMAN PRESCRIPTION DRUG LABEL	1