Triamcinolone acetonide

Product NDC: 70518-3373
Requested package NDC: 70518-3373-0
11-digit product format: 705183373
Labeler code: 70518
Product ID: 70518-3373_e39f5ba2-6e47-d7f4-e053-2a95a90a91f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA209828
Marketing category: ANDA
Marketing start: 2022-02-25
Marketing end: 0000-00-00
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-3373	70518-3373-0	D	Discontinued by firm		2026-08-17

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 · 10 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…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-002	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-003	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	2018-11-23	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209828-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209828-001	AT	1	`1e350fbaab3a…`

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 · 7 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.	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	REMEDYREPACK INC.	d10b5451-5685-489e-b123-55c99d33c5b2	2025-09-29	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	Marketing end	Sample	Exclude flag	Status
70518-3373-0	70518337300	1 TUBE in 1 CARTON (70518-3373-0) > 80 g in 1 TUBE	1 tube	2022-02-25	0000-00-00	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	REMEDYREPACK INC.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3