Triamcinolone Acetonide

Product NDC: 85766-016
Requested package NDC: 85766-016-10
11-digit product format: 857660016
Labeler code: 85766
Product ID: 85766-016_4a85c1c3-44c7-dc0b-e063-6394a90a6d1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRAMUSCULAR
Labeler: Sportpharm LLC
Application: ANDA207550
Marketing category: ANDA
Marketing start: 2019-11-19
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 400 mg/10mL
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 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
A207550-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB		2017-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207550-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	2017-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207550-001	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	BX	2017-12-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207550-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207550-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207550-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207550-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207550-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207550-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207550-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207550-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207550-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207550-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207550-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207550-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207550-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207550-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207550-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207550-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207550-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207550-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207550-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207550-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207550-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207550-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207550-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207550-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207550-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207550-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207550-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207550-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207550-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207550-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207550-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207550-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207550-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207550-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207550-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207550-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207550-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207550-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207550-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207550-001	BX	1	`cb3db0bc1861…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085754	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
4e0ddecf-7ea1-4f42-9924-53fe5a5657ff	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
85766-016-01	Triamcinolone Acetonide	10 mL in 1 VIAL	INJECTION, SUSPENSION	10	3
85766-016-01	Triamcinolone Acetonide	1 in 1 CARTON	INJECTION, SUSPENSION	1	3
85766-016-10	Triamcinolone Acetonide	1 in 1 CARTON	INJECTION, SUSPENSION	1	3
85766-016-10	Triamcinolone Acetonide	10 mL in 1 VIAL	INJECTION, SUSPENSION	10	3

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Amneal Pharmaceuticals LLC	6b6eed06-ff96-4ceb-bb0c-a67a149987a4	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Amneal Pharmaceuticals LLC	bf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NorthStar Rx LLC	5f3aaf3a-cc66-4d4f-b9b7-2c50c325d477	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	cfae0704-e754-419b-bbdc-69e7867a8a5a	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	8d11aee3-b66e-439b-9188-7d91219a59cf	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	e55f3f0f-bd52-47e4-b77d-73ede1b41466	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Amneal Pharmaceuticals LLC	c38dcd37-9840-4f71-a5c9-97380c8107f2	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	4e0ddecf-7ea1-4f42-9924-53fe5a5657ff	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550 ndc (package): 85766-016-10 ndc (product): 85766-016 ndc11 (package): 85766001610
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	ASCLEMED USA INC.	1c6a740e-bc0d-41f3-b576-7d4c3880be23	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	ASCLEMED USA INC.	b909659e-8dd5-4652-89f4-c4d6b741a855	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	cab0573d-e760-4ff5-a69f-0ce06cfdb97a	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207550 application number: ANDA207550

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
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	PSN	4e0ddecf-7ea1-4f42-9924-53fe5a5657ff	3
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	SCD	4e0ddecf-7ea1-4f42-9924-53fe5a5657ff	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-016-10	85766001610	1 VIAL in 1 CARTON (85766-016-10) / 10 mL in 1 VIAL	1 vial	2025-06-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide	Sportpharm LLC \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	3