Home NDC 33342-481 Nystatin
Product NDC 33342-481
11-digit product format 333420481
Labeler code 33342
Product ID 33342-481_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form OINTMENT
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA213826
Marketing category ANDA
Marketing start 2021-01-29
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 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 A213826-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2021-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213826-001 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 A213826-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2021-01-14 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 A213826-001 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 · 1 matching rows.
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 884308 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 33342-481-15 Nystatin 1 in 1 CARTON OINTMENT 1 1 33342-481-15 Nystatin 15 g in 1 TUBE OINTMENT 15 1 33342-481-30 Nystatin 30 g in 1 TUBE OINTMENT 30 1 33342-481-30 Nystatin 1 in 1 CARTON OINTMENT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-481 NYSTATIN OINTMENT [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, Legacy NDC, 4 package rows 20210130_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8.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 33342-481-15 33342048115 1 TUBE in 1 CARTON (33342-481-15) / 15 g in 1 TUBE 1 tube 2021-01-29 0000-00-00 No No Current 33342-481-30 33342048130 1 TUBE in 1 CARTON (33342-481-30) / 30 g in 1 TUBE 1 tube 2021-01-29 0000-00-00 No No Current