Nystatin and Triamcinolone Acetonide

Product NDC
76413-120
11-digit product format
764130120
Labeler code
76413
Product ID
76413-120_8cc9492c-d487-4dc4-a506-6a57d8c11d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Central Texas Community Health Centers
Application
ANDA062364
Marketing category
ANDA
Marketing start
1987-12-22
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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-120IInactivated by FDA2026-08-17
excluded packagepackage76413-12076413-120-15IInactivated by FDA2026-08-17

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-120-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-120-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-120-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-120-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-120-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-120-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-120-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-120-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-120-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-120-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-120-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-120-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76413-120-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76413-120-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76413-120-151332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76413-120-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76413-120-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76413-120-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76413-120-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76413-120-15e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76413-120-159bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062364-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A062364-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062364-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062364-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062364-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062364-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062364-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062364-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062364-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062364-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062364-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062364-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062364-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062364-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062364-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062364-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062364-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062364-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062364-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062364-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062364-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062364-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062364-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062364-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062364-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062364-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062364-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062364-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062364-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062364-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062364-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062364-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062364-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062364-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062364-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062364-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062364-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062364-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062364-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062364-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062364-001AT1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-120-152020-01-31C16284748780-19d75b9d1-041a-f424-e053-dadaa90a57ceNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.ea065dd4-dfd3-46a2-92de-8a0b49cb94552026-01-14Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.2fd97fc5-cae5-43dd-a3c7-c9a03876153e2025-07-07Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.90a58c0e-85cf-3aad-e053-2a95a90a316a2024-06-19Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364