KENALOG-40

Product NDC: 50090-0256
Requested package NDC: 50090-0256-0
11-digit product format: 500900256
Labeler code: 50090
Product ID: 50090-0256_3841db38-7783-4537-9e04-964983a434ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRIAMCINOLONE ACETONIDE
Dosage form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR; INTRAMUSCULAR
Labeler: A-S Medication Solutions
Application: NDA014901
Marketing category: NDA
Marketing start: 2009-06-01
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 40 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N014901-001	KENALOG-40	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982
N014901-002	KENALOG-80	TRIAMCINOLONE ACETONIDE	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N014901-001	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014901-001	KENALOG-40	40MG/ML	INJECTABLE / INJECTION	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014901-002	KENALOG-80	80MG/ML	INJECTABLE / INJECTION		RLD, RS	2019-04-12	`782e0a99824c…`

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	N014901-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014901-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014901-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014901-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014901-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014901-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014901-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014901-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014901-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014901-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014901-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014901-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014901-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014901-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014901-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014901-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014901-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014901-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014901-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014901-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014901-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014901-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014901-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014901-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014901-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014901-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014901-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014901-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014901-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014901-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014901-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014901-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014901-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014901-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014901-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014901-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014901-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014901-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N014901-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N014901-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: KENALOG-40
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIAMCINOLONE ACETONIDE	40 mg/mL

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
1085756	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
cb0480b8-44ee-4506-b484-dc776c3092dc	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0256-0	2023-02-08	C162847	48780-1	f386c649-e479-0266-e053-dadaa90a7c1a	KENALOG-40
50090-0256-0	2023-01-30	C162847	48780-1	f386c649-e479-0266-e053-dadaa90a7c1a	KENALOG-40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0256-0	KENALOG-40	1 in 1 CARTON	INJECTION, SUSPENSION	1		24
50090-0256-0	KENALOG-40	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	5		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0256-0	ML - Milliliter	50090-0256	7eddd05b-fd57-471b-8cc1-0a0e116836b9	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0256	KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]	24	Current NDC, Legacy NDC, 2 package rows	20230811_cb0480b8-44ee-4506-b484-dc776c3092dc.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	d26b97b8-edc8-4b93-b6b9-429016208ff9	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901
KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	cf970688-cd77-b95c-4bd9-c541590e9722	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	cb0480b8-44ee-4506-b484-dc776c3092dc	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901 ndc (package): 50090-0256-0 ndc (product): 50090-0256 ndc11 (package): 50090025600
KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	1ed85825-cd03-4b5b-9c9a-946653b5f71a	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901
KENALOG-40	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	0bc9c75f-963c-40b0-995b-dfcbd50371a5	2020-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014901 application number: NDA014901

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
1085756	Kenalog 40 MG/ML Injectable Suspension	PSN	cb0480b8-44ee-4506-b484-dc776c3092dc	24
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	PSN	cb0480b8-44ee-4506-b484-dc776c3092dc	24
1085756	triamcinolone acetonide 40 MG/ML Injectable Suspension [Kenalog]	SBD	cb0480b8-44ee-4506-b484-dc776c3092dc	24
1085754	triamcinolone acetonide 40 MG/ML Injectable Suspension	SCD	cb0480b8-44ee-4506-b484-dc776c3092dc	24
1085756	Kenalog 40 MG/ML Injectable Suspension	SY	cb0480b8-44ee-4506-b484-dc776c3092dc	24
1085756	Kenalog-40 40 MG/ML Injectable Suspension	SY	cb0480b8-44ee-4506-b484-dc776c3092dc	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0256-0	50090025600	1 VIAL, MULTI-DOSE in 1 CARTON (50090-0256-0) / 5 mL in 1 VIAL, MULTI-DOSE	2016-06-29	0000-00-00	No	No	Current