Home NDC 33342-482 Nystatin and triamcinolone acetonide
Product NDC 33342-482
11-digit product format 333420482
Labeler code 33342
Product ID 33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin and triamcinolone acetonide
Dosage form CREAM
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA214181
Marketing category ANDA
Marketing start 2022-08-31
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 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214181-001 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.
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 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214181-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT 2022-07-13 a50c72e98297…
Observed Orange Book normalized TE history# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-482-15 Nystatin and triamcinolone acetonide 1 in 1 CARTON CREAM 1 2 33342-482-15 Nystatin and triamcinolone acetonide 15 g in 1 TUBE CREAM 15 2 33342-482-30 Nystatin and triamcinolone acetonide 1 in 1 CARTON CREAM 1 2 33342-482-30 Nystatin and triamcinolone acetonide 30 g in 1 TUBE CREAM 30 2 33342-482-60 Nystatin and triamcinolone acetonide 60 g in 1 TUBE CREAM 60 2 33342-482-60 Nystatin and triamcinolone acetonide 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-482 NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 6 package rows 20230912_57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33342-482-15 33342048215 1 TUBE in 1 CARTON (33342-482-15) / 15 g in 1 TUBE 1 tube 2022-08-31 0000-00-00 No No Current 33342-482-30 33342048230 1 TUBE in 1 CARTON (33342-482-30) / 30 g in 1 TUBE 1 tube 2022-08-31 0000-00-00 No No Current 33342-482-60 33342048260 1 TUBE in 1 CARTON (33342-482-60) / 60 g in 1 TUBE 1 tube 2022-08-31 0000-00-00 No No Current