Triamcinolone acetonide

Product NDC: 67296-2327
Requested package NDC: 67296-2327-1
11-digit product format: 672962327
Labeler code: 67296
Product ID: 67296-2327_5a7962f5-643f-e6df-e063-6394a90ab86d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA209828
Marketing category: ANDA
Marketing start: 2025-04-02
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 43.

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	Approval date
A209828-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23
A209828-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23
A209828-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209828-001	AT
A209828-002	AT
A209828-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209828-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209828-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209828-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209828-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209828-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209828-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209828-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209828-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209828-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209828-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209828-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209828-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209828-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209828-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209828-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209828-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209828-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209828-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209828-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209828-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-001	AT	1	`301d65b070ca…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F446C597KA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085636	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5a79639b-eb66-e726-e063-6394a90aeb01	Available on FDA.report

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Redpharm Drug	5a79639b-eb66-e726-e063-6394a90aeb01	2026-09-02	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828 ndc (package): 67296-2327-1 ndc (product): 67296-2327 ndc11 (package): 67296232701
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	d10b5451-5685-489e-b123-55c99d33c5b2	2026-08-31	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	bd465674-3527-1590-e053-2995a90a958d	2026-02-19	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	037efc03-22ab-45eb-9b0e-b125e4b5eb99	2026-01-20	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NorthStar RxLLC	3379f247-4a29-4373-9843-0b7f044c2276	2025-04-03	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	b3d21abc-8952-45c3-b8cf-efa4dcce268d	2023-12-28	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	6bb0edc7-643b-4b20-aa48-ee3b22bce575	2023-10-01	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	4dc6fa38-0225-4b99-8cef-4fee72a30f90	2023-07-01	Adverse reactions	Exact identifier application applno (ANDA): 209828 application number: ANDA209828

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
67296-2327-1	67296232701	1 TUBE in 1 CARTON (67296-2327-1) / 15 g in 1 TUBE	1 tube	2025-04-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide Ointment USP, 0.025%, 0.1%, 0.5% Rx Only	Redpharm Drug	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	1