Nystatin and Triamcinolone Acetonide

Product NDC: 68382-332
Requested package NDC: 68382-332-03
11-digit product format: 683820332
Labeler code: 68382
Product ID: 68382-332_dada008c-5278-4a95-83b0-bba4f4999ac3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin and Triamcinolone Acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA207764
Marketing category: ANDA
Marketing start: 2018-11-20
Marketing end: 0000-00-00
Substance: NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength: 100000 [USP'U]/g; mg/g
Pharmacologic classes: Polyene Antifungal [EPC],Polyenes [CS],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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68382-332	68382-332-03	D	Discontinued by firm		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 · 12 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…`

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
A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT		2018-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207764-001	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	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2018-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2018-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2018-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL		2018-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207764-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2018-11-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207764-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207764-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207764-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207764-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207764-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207764-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207764-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207764-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207764-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207764-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207764-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207764-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207764-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207764-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207764-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207764-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207764-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207764-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207764-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207764-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207764-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207764-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207764-001	AT	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207764-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207764-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207764-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207764-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207764-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207764-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207764-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207764-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207764-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207764-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207764-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207764-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207764-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207764-001	AT	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Zydus Lifesciences Limited	7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f	2024-08-16		Exact identifier application applno (ANDA): 207764 application number: ANDA207764
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Viona Pharmaceuticals Inc	d3799da3-5923-4225-9c61-2b5af143f555	2022-10-08	Adverse reactions	Exact identifier application applno (ANDA): 207764 application number: ANDA207764

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-332-03	68382033203	1 TUBE in 1 CARTON (68382-332-03) > 60 g in 1 TUBE	1 tube	2018-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin and Triamcinolone Acetonide Ointment, USP	Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2020-12-17	HUMAN PRESCRIPTION DRUG LABEL	3