FDA.reportPublic FDA data

Nystatin and Triamcinolone Acetonide

Product NDC
53002-9360
Requested package NDC
53002-9360-1
11-digit product format
530029360
Labeler code
53002
Product ID
53002-9360_e62215be-cd16-464f-82d2-88c971414fa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-936053002-9360-1IInactivated by FDA2026-08-03

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-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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062364-001AT1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 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 ACETONIDEPreferred Pharmaceuticals Inc.4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd2025-08-28Adverse 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

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
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9360-12025-01-30C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
53002-9360-22025-01-30C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
53002-9360-12023-06-07C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
53002-9360-22023-06-07C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
53002-9360-12023-01-30C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP
53002-9360-22023-01-30C16284748780-1f386c649-a9e8-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP Nystatin and Triamcinolone Acetonide Ointment, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9360-1Nystatin and Triamcinolone Acetonide15 g in 1 TUBECREAM154
53002-9360-2Nystatin and Triamcinolone Acetonide30 g in 1 TUBECREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9360NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20230609_e935821e-4e1b-4b5c-b943-5332c0b7a76b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNe935821e-4e1b-4b5c-b943-5332c0b7a76b4
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDe935821e-4e1b-4b5c-b943-5332c0b7a76b4
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYe935821e-4e1b-4b5c-b943-5332c0b7a76b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9360-15300293600115 g in 1 TUBE (53002-9360-1) 15 g2021-01-010000-00-00NoNoCurrent