Nystatin and Triamcinolone Acetonide

Product NDC: 68071-5037
Requested package NDC: 68071-5037-3
11-digit product format: 680715037
Labeler code: 68071
Product ID: 68071-5037_1b4117fd-e008-682d-e063-6394a90a89a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin and Triamcinolone Acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA062364
Marketing category: ANDA
Marketing start: 1987-12-22
Substance: NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength: 100000; 1 [USP'U]/g; mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5037	68071-5037-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5037	68071-5037-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5037	68071-5037-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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
A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062364-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062364-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM / TOPICAL	AT	RS	1987-12-22	`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	A062364-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062364-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062364-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062364-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062364-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062364-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062364-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062364-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062364-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062364-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062364-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062364-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062364-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062364-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062364-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062364-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062364-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062364-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062364-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062364-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062364-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062364-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062364-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062364-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062364-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062364-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062364-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062364-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062364-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062364-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062364-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062364-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062364-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062364-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062364-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062364-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062364-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062364-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062364-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062364-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nystatin and Triamcinolone Acetonide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NYSTATIN	100000 [USP'U]/g
TRIAMCINOLONE ACETONIDE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BDF1O1C72E	Internal UNII lookup
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
1053753	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
90a58c0e-85cf-3aad-e053-2a95a90a316a	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
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#

Effective, Related label table
Effective	Related label
2024-06-19	Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
2023-01-30	Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
2021-02-19	Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
2021-01-29	Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5037-3	Nystatin and Triamcinolone Acetonide	30 g in 1 TUBE	CREAM	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5037	NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240620_90a58c0e-85cf-3aad-e053-2a95a90a316a.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 · 4 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	REMEDYREPACK INC.	ea065dd4-dfd3-46a2-92de-8a0b49cb9455	2026-01-14	Adverse reactions	Exact identifier application applno (ANDA): 062364 application number: ANDA062364
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd	2025-08-28	Adverse reactions	Exact identifier application applno (ANDA): 062364 application number: ANDA062364
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	2fd97fc5-cae5-43dd-a3c7-c9a03876153e	2025-07-07	Adverse reactions	Exact identifier application applno (ANDA): 062364 application number: ANDA062364
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	90a58c0e-85cf-3aad-e053-2a95a90a316a	2024-06-19	Adverse reactions	Exact identifier application applno (ANDA): 062364 application number: ANDA062364 ndc (package): 68071-5037-3 ndc (product): 68071-5037 ndc11 (package): 68071503703

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
1053753	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream	PSN	90a58c0e-85cf-3aad-e053-2a95a90a316a	3
1053753	nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream	SCD	90a58c0e-85cf-3aad-e053-2a95a90a316a	3
1053753	nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream	SY	90a58c0e-85cf-3aad-e053-2a95a90a316a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5037-3	68071503703	30 g in 1 TUBE (68071-5037-3)	30 g	2019-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3