Nystatin and Triamcinolone Acetonide

Product NDC: 52565-042
Requested package NDC: 52565-042-30
11-digit product format: 525650042
Labeler code: 52565
Product ID: 52565-042_1090fb75-b1de-4939-8695-2870797e40bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin and Triamcinolone Acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA208287
Marketing category: ANDA
Marketing start: 2016-12-30
Marketing end: 0000-00-00
Substance: NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength: 100000 [USP'U]/g; mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-042	52565-042-30	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL			2016-12-30

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	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2016-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208287-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2016-12-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208287-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208287-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208287-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208287-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208287-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208287-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208287-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208287-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208287-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208287-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208287-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208287-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208287-001	AT	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208287-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208287-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208287-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208287-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208287-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208287-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208287-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208287-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
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
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
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
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
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
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508
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
52565-042-15	2023-01-30	C162847	48780-1	f386c64a-2d76-0266-e053-dadaa90a7c1a	Nystatin and Triamcinolone Acetonide Ointment, USP
52565-042-30	2023-01-30	C162847	48780-1	f386c64a-2d76-0266-e053-dadaa90a7c1a	Nystatin and Triamcinolone Acetonide Ointment, USP
52565-042-60	2023-01-30	C162847	48780-1	f386c64a-2d76-0266-e053-dadaa90a7c1a	Nystatin and Triamcinolone Acetonide Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-042-15	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	2
52565-042-15	Nystatin and Triamcinolone Acetonide	15 g in 1 TUBE	OINTMENT	15	2
52565-042-30	Nystatin and Triamcinolone Acetonide	30 g in 1 TUBE	OINTMENT	30	2
52565-042-30	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	2
52565-042-60	Nystatin and Triamcinolone Acetonide	60 g in 1 TUBE	OINTMENT	60	2
52565-042-60	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-042-15	GM - Gram	52565-042	2853beb7-0a69-4f23-af54-2691470c9cd3	1	2017-03-06
52565-042-30	GM - Gram	52565-042	3980074b-de5f-4428-9d4b-75e93e9cda2e	1	2017-03-06
52565-042-60	GM - Gram	52565-042	a30354d2-6827-4029-b253-6222ef335b6e	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-042	NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]	2	Legacy NDC, 6 package rows	20190911_373276df-6a72-44cb-82a2-4098a16d86c7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BDF1O1C72E	NYSTATIN	1400-61-9	NYSTATIN
F446C597KA	TRIAMCINOLONE ACETONIDE	76-25-5	TRIAMCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	373276df-6a72-44cb-82a2-4098a16d86c7	2
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	373276df-6a72-44cb-82a2-4098a16d86c7	2
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	373276df-6a72-44cb-82a2-4098a16d86c7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-042-30	52565004230	1 TUBE in 1 CARTON (52565-042-30) > 30 g in 1 TUBE	1 tube	2016-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin and Triamcinolone Acetonide Ointment, USP	Teligent Pharma, Inc.	2016-12-30	HUMAN PRESCRIPTION DRUG LABEL	2