Home NDC 33342-469 Nystatin
Product NDC 33342-469
11-digit product format 333420469
Labeler code 33342
Product ID 33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA213566
Marketing category ANDA
Marketing start 2021-08-25
Substance NYSTATIN
Active strength 100000 1/g
Pharmacologic classes 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 42 .
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 A213566-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213566-001 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 2026-08-18 06:07:40 2026-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213566-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT 2021-08-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 1/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543546 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 33342-469-15 Nystatin 15 g in 1 TUBE CREAM 15 1 33342-469-15 Nystatin 1 in 1 CARTON CREAM 1 1 33342-469-30 Nystatin 1 in 1 CARTON CREAM 1 1 33342-469-30 Nystatin 30 g in 1 TUBE CREAM 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-469 NYSTATIN CREAM [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, Legacy NDC, 4 package rows 20210826_d8ebb61a-a326-4f0d-a346-c3db045c3fb0.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 33342-469-15 33342046915 1 TUBE in 1 CARTON (33342-469-15) / 15 g in 1 TUBE 1 tube 2021-08-25 0000-00-00 No No Current 33342-469-30 33342046930 1 TUBE in 1 CARTON (33342-469-30) / 30 g in 1 TUBE 1 tube 2021-08-25 0000-00-00 No No Current