TRIAMCINOLONE ACETONIDE

Product NDC: 67457-623
11-digit product format: 674570623
Labeler code: 67457
Product ID: 67457-623_62c6d537-d5d7-470d-9150-c812aae062ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRIAMCINOLONE ACETONIDE
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRAMUSCULAR
Labeler: Mylan Institutional LLC
Application: ANDA212567
Marketing category: ANDA
Marketing start: 2023-05-08
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 400 mg/10mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	67457-623	67457-623-10	D	Discontinued by firm		2026-08-03

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
A212567-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB		2022-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212567-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212567-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2022-11-02	`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	A212567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212567-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212567-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212567-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212567-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212567-001	AB	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212567-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: TRIAMCINOLONE ACETONIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIAMCINOLONE ACETONIDE	400 mg/10mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085754	Internal RxNorm lookup
1792144	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
4015ad7d-46bf-454e-ac86-91fa5dd6a07b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
75f7e47b-8736-a182-fc44-22aca8d79689	Product name	2	20251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2	Product name	6	20250516
e42f429b-c4e5-0402-e1c5-730154df4060	Product name	4	20240205
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
089e0644-1ea8-8654-4113-39f960dd57d5	Product name	3	20210115
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
9f64e0dc-109c-9660-8e0e-91ec987b3817	Product name	6	20171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002f	Product name	1	20171204
8de20f81-8411-4cf1-a8b2-03404ee56d01	Product name	3	20171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8	Product name	2	20160819
355b2224-0895-7135-83f5-d099a6a82a0a	Product name	1	20140508
55be6b50-8cc0-f0f1-74a1-3416a91193aa	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67457-623-10	TRIAMCINOLONE ACETONIDE	1 in 1 CARTON	INJECTION, SUSPENSION	1	6
67457-623-10	TRIAMCINOLONE ACETONIDE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	6
67457-623-99	TRIAMCINOLONE ACETONIDE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10	6
67457-623-99	TRIAMCINOLONE ACETONIDE	25 in 1 CARTON	INJECTION, SUSPENSION	25	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-623-10	ML - Milliliter	67457-623	576efa1b-8709-469e-9748-8fec3be312e6	1	2023-06-06
67457-623-99	ML - Milliliter	67457-623	53d545bd-c739-4e40-9e6d-55c7bfb54c05	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-623	TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION [MYLAN INSTITUTIONAL LLC]	6	Current NDC, 4 package rows	20250507_4015ad7d-46bf-454e-ac86-91fa5dd6a07b.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Mylan Institutional LLC	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212567 application number: ANDA212567 ndc (product): 67457-623

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F446C597KA	TRIAMCINOLONE ACETONIDE	76-25-5	TRIAMCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1792144	triamcinolone acetonide 40 MG in 1 ML Injection	PSN	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	6
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	PSN	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	6
1792144	1 ML triamcinolone acetonide 40 MG/ML Injection	SCD	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	6
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	SCD	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	6
1792144	triamcinolone acetonide 40 MG per 1 ML Injection	SY	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67457-623-10	67457062310	1 in 1 CARTON				Historical
67457-623-99	67457062399	25 VIAL, MULTI-DOSE in 1 CARTON (67457-623-99) / 10 mL in 1 VIAL, MULTI-DOSE	2024-08-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide Injectable Suspension, USP	Mylan Institutional LLC	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	6