Triamcinolone Acetonide

Product NDC: 64380-870
11-digit product format: 643800870
Labeler code: 64380
Product ID: 64380-870_a16f57bb-ad68-4ff7-9911-11c792563b20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamcinolone Acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Strides Pharma Science Limited
Application: ANDA211315
Marketing category: ANDA
Marketing start: 2021-06-30
Marketing end: 0000-00-00
Substance: TRIAMCINOLONE ACETONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64380-870		D	Discontinued by firm	2026-08-17
excluded package	package	64380-870	64380-870-22	D	Discontinued by firm	2026-08-17
excluded package	package	64380-870	64380-870-36	D	Discontinued by firm	2026-08-17
excluded package	package	64380-870	64380-870-37	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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64380-870-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64380-870-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64380-870-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64380-870-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64380-870-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64380-870-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64380-870-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64380-870-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64380-870-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64380-870-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64380-870-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64380-870-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64380-870-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64380-870-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64380-870-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64380-870-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64380-870-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64380-870-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64380-870-22	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64380-870-36	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64380-870-37	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64380-870-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64380-870-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64380-870-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64380-870-22	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64380-870-36	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64380-870-37	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64380-870-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64380-870-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64380-870-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64380-870-22	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64380-870-36	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64380-870-37	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64380-870-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64380-870-36	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64380-870-37	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A211315-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL			2020-03-18
A211315-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL			2020-03-18

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211315-001	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	2020-03-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211315-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	2020-03-18	`782e0a99824c…`

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
64380-870-22	64380087022	1 TUBE in 1 CARTON (64380-870-22) > 15 g in 1 TUBE	1 tube	2021-06-30	0000-00-00	No	No	Current
64380-870-36	64380087036	1 TUBE in 1 CARTON (64380-870-36) > 80 g in 1 TUBE	1 tube	2021-06-30	0000-00-00	No	No	Current
64380-870-37	64380087037	454 g in 1 JAR (64380-870-37)	454 g	2021-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamcinolone Acetonide Ointment USP, 0.1%, 0.5% Rx Only	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd.	2020-07-10	HUMAN PRESCRIPTION DRUG LABEL	5

Triamcinolone Acetonide

NDC auxiliary status#

Observed NDC auxiliary status history#

Orange Book products#

Observed Orange Book product history#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#