NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product NDC
68071-2478
Requested package NDC
68071-2478-5
11-digit product format
680712478
Labeler code
68071
Product ID
68071-2478_c77dbcad-7c52-4c1b-e053-2995a90aeb71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin, triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208479
Marketing category
ANDA
Marketing start
2017-11-27
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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-247868071-2478-5DDiscontinued by firm2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208479-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1484e616aacf4f…
2026-08-18 06:07:402026-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143f01610625f2…
2019-09-15 20:21 UTC2019-09A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208479-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A208479-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208479-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208479-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208479-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208479-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208479-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208479-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208479-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208479-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208479-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208479-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208479-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208479-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208479-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208479-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208479-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208479-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208479-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208479-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208479-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208479-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208479-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A208479-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208479-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208479-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208479-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A208479-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208479-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208479-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208479-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208479-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208479-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208479-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208479-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208479-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208479-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208479-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208479-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208479-001AT1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2478-52023-01-30C16284748780-1f386c64a-3908-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2478NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN, TRIAMCINOLONE ACETONIDE) CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210720_c77dbcad-7c51-4c1b-e053-2995a90aeb71.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackf81f461b-54cd-45bf-bf96-da77a5edc1e62025-10-28Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc82fc464-d021-4a7c-8141-46d3d80134a22025-05-07Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.c8beaa42-eb3a-d160-e053-2a95a90a31082024-10-03Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackb3056a63-d149-4ed4-84bc-918f5ff94a622024-08-22Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack92b08b14-a933-454b-8b6f-4b5e7c6829532024-08-06Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack6f25f129-a682-47d0-8788-bac21b65c8302024-03-29Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd92fc188d-4f3e-4d18-aaf1-c9e76b12b75b2023-03-01Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2478-5680712478051 TUBE in 1 CARTON (68071-2478-5) > 15 g in 1 TUBE1 tube2021-07-190000-00-00NoNoCurrent