Nystatin and Triamcinolone Acetonide

Product NDC: 21922-031
11-digit product format: 219220031
Labeler code: 21922
Product ID: 21922-031_b18e996f-bdb8-4028-9862-fbab75aebf69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nystatin and Triamcinolone Acetonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Encube Ethicals, Inc.
Application: ANDA207741
Marketing category: ANDA
Marketing start: 2019-09-28
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

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
A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT		2017-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207741-001	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	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207741-001	NYSTATIN AND TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	OINTMENT / TOPICAL	AT	2017-01-31	`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	A207741-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207741-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207741-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207741-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207741-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207741-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207741-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207741-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207741-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207741-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207741-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207741-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207741-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207741-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207741-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207741-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207741-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207741-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207741-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207741-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207741-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207741-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207741-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207741-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207741-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207741-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207741-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207741-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207741-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207741-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207741-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207741-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207741-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207741-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207741-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207741-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207741-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207741-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207741-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207741-001	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
1053697	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
d33829fc-86df-4e28-82c3-9dbcd8a9e28d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21922-031-04	Nystatin and Triamcinolone Acetonide	15 g in 1 TUBE	OINTMENT	15	3
21922-031-04	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	3
21922-031-05	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	3
21922-031-05	Nystatin and Triamcinolone Acetonide	30 g in 1 TUBE	OINTMENT	30	3
21922-031-07	Nystatin and Triamcinolone Acetonide	1 in 1 CARTON	OINTMENT	1	3
21922-031-07	Nystatin and Triamcinolone Acetonide	60 g in 1 TUBE	OINTMENT	60	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-031-04	GM - Gram	21922-031	ae913c2b-f20d-4707-95df-b1af5304e808	1	2019-11-12
21922-031-05	GM - Gram	21922-031	80febd02-fce9-43e9-a532-31e75ac3da28	1	2019-11-12
21922-031-07	GM - Gram	21922-031	4ba38dd5-d397-496e-9aa4-65f53929a3ed	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21922-031	NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]	2	Current NDC, Legacy NDC, 6 package rows	20220115_d33829fc-86df-4e28-82c3-9dbcd8a9e28d.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 · 7 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	Bryant Ranch Prepack	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Encube Ethicals, Inc.	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	2025-08-29	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741 ndc (product): 21922-031
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ec28a12b-96f8-44ff-a440-8cff34ac2095	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c62979d3-c9a4-4d94-956e-30760266daf4	2024-08-20	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3dab5155-9c86-464b-b41b-1507ff49a694	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741
Nystatin and Triamcinolone Acetonide	NYSTATIN AND TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	2024-03-14	Adverse reactions	Exact identifier application applno (ANDA): 207741 application number: ANDA207741

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	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	1089
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	1089
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	f3e21d77-7ca9-4ca9-97f9-b394f7202aa6	1089
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	3dab5155-9c86-464b-b41b-1507ff49a694	108
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	c62979d3-c9a4-4d94-956e-30760266daf4	108
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	3dab5155-9c86-464b-b41b-1507ff49a694	108
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	c62979d3-c9a4-4d94-956e-30760266daf4	108
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	3dab5155-9c86-464b-b41b-1507ff49a694	108
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	c62979d3-c9a4-4d94-956e-30760266daf4	108
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	ec28a12b-96f8-44ff-a440-8cff34ac2095	104
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	ec28a12b-96f8-44ff-a440-8cff34ac2095	104
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	ec28a12b-96f8-44ff-a440-8cff34ac2095	104
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	100
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	100
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	100
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	100
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	d36c64f7-5481-45e4-ac9c-e16ae2194c6e	100
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	26fd7fb6-6eeb-47f1-bbc4-001e84f99625	100
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment	PSN	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	3
1053697	nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment	SCD	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	3
1053697	nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment	SY	d33829fc-86df-4e28-82c3-9dbcd8a9e28d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21922-031-04	21922003104	1 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBE	1 tube	2019-09-28	0000-00-00	No	No	Current
21922-031-05	21922003105	1 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBE	1 tube	2019-09-28	0000-00-00	No	No	Current
21922-031-07	21922003107	1 TUBE in 1 CARTON (21922-031-07) / 60 g in 1 TUBE	1 tube	2019-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	100
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	100
Nystatin and Triamcinolone Acetonide	Encube Ethicals, Inc. \| Dr. Reddy's Laboratories Inc. \| Encube Ethicals Private Limited	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	3
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2024-11-06	HUMAN PRESCRIPTION DRUG LABEL	104
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	108
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2024-06-06	HUMAN PRESCRIPTION DRUG LABEL	108
Nystatin and Triamcinolone Acetonide	Bryant Ranch Prepack	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	1089