Home NDC 50090-5237-0 Nystatin
Product NDC 50090-5237
Requested package NDC 50090-5237-0
11-digit product format 500905237
Labeler code 50090
Product ID 50090-5237_20f4f308-1b63-4baa-91e2-586973bef9a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form OINTMENT
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA209114
Marketing category ANDA
Marketing start 2017-10-06
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A209114-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209114-001 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.
Product history page 1 of 2 · 41 observed 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 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209114-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2017-10-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5237-0 50090523700 1 TUBE in 1 CARTON (50090-5237-0) > 15 g in 1 TUBE 1 tube 2020-10-09 0000-00-00 No No Current