Home NDC 50090-3799 Nystatin
Product NDC 50090-3799
11-digit product format 500903799
Labeler code 50090
Product ID 50090-3799_f3cbc0e5-76a5-4dcd-91b3-4e1275c11c51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA061966
Marketing category ANDA
Marketing start 2015-04-01
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 2020-12-31
Current FDA listing Historical FDA.report record 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 A061966-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A061966-001 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 2026-08-01 22:54:32 2026-06 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A061966-001 AT 1 a50c72e98297…
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 · 5 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3799-0 Nystatin 1 in 1 CARTON CREAM 1 1 50090-3799-0 Nystatin 15 g in 1 TUBE CREAM 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3799 NYSTATIN (NYSTATIN) CREAM [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 2 package rows 20190103_98bd8ccb-0c68-47b9-bcb4-c5d8217868d9.zip
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 50090-3799-0 50090379900 1 TUBE in 1 CARTON (50090-3799-0) > 15 g in 1 TUBE 1 tube 2018-11-08 0000-00-00 No No Current