TRIAMCINOLONE ACETONIDE

Product NDC: 70518-4527
11-digit product format: 705184527
Labeler code: 70518
Product ID: 70518-4527_450bf541-88d3-d179-e063-6294a90aeb49
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA208848
Marketing category: ANDA
Marketing start: 2025-12-02
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208848-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT		2017-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208848-001	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 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	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208848-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2017-09-18	`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	A208848-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208848-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208848-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208848-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208848-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208848-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208848-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208848-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208848-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208848-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208848-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208848-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208848-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208848-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208848-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208848-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208848-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208848-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208848-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208848-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208848-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208848-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208848-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208848-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208848-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208848-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208848-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208848-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208848-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208848-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208848-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208848-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208848-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208848-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208848-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208848-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208848-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208848-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208848-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208848-001	AT	1	`cb3db0bc1861…`

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	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
1014314	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
abad7215-95d2-4171-95cf-fa768081fd3b	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4527-0	TRIAMCINOLONE ACETONIDE	1 in 1 CARTON	CREAM	1		1
70518-4527-0	TRIAMCINOLONE ACETONIDE	80 g in 1 TUBE	CREAM	80		1

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	Encube Ethicals, Inc.	db87426f-124c-4ea9-bb15-fc3a0da10a4e	2026-07-07	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Direct_rx	4e400049-c763-56f7-e063-6294a90a6fd7	2026-03-30	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	60973042-077c-4265-988c-ad381f560333	2026-01-19	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	abad7215-95d2-4171-95cf-fa768081fd3b	2025-12-03	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848 ndc (product): 70518-4527
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	c6e46d6f-c64d-4242-a56f-8aff96e68993	2024-10-01	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	200bb913-a6ac-5a6b-e063-6294a90a161a	2024-08-19	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	69aec845-3d4a-d226-e053-2991aa0afd12	2024-06-10	Adverse reactions	Exact identifier application applno (ANDA): 208848 application number: ANDA208848

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
1014314	triamcinolone acetonide 0.1 % Topical Cream	PSN	abad7215-95d2-4171-95cf-fa768081fd3b	1
1014314	triamcinolone acetonide 1 MG/ML Topical Cream	SCD	abad7215-95d2-4171-95cf-fa768081fd3b	1
1014314	triamcinolone acetonide 0.1 % Topical Cream	SY	abad7215-95d2-4171-95cf-fa768081fd3b	1
1014314	triamcinolone acetonide 1 MG per GM Topical Cream	SY	abad7215-95d2-4171-95cf-fa768081fd3b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4527-0	70518452700	1 TUBE in 1 CARTON (70518-4527-0) / 80 g in 1 TUBE	1 tube	2025-12-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% Rx only	REMEDYREPACK INC.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	1