Home NDC 69315-307 NYSTATIN
Product NDC 69315-307
11-digit product format 693150307
Labeler code 69315
Product ID 69315-307_520822eb-a9f1-4017-9a73-1979ee53f4e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NYSTATIN
Dosage form OINTMENT
Route TOPICAL
Labeler Leading Pharma, LLC
Application ANDA209082
Marketing category ANDA
Marketing start 2019-08-19
Substance NYSTATIN
Active strength 100000 [USP'U]/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 A209082-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209082-001 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 A209082-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 2018-05-21 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 A209082-001 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 [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 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 69315-307-15 NYSTATIN 15 g in 1 TUBE OINTMENT 15 5 69315-307-15 NYSTATIN 1 in 1 CARTON OINTMENT 1 5 69315-307-30 NYSTATIN 30 g in 1 TUBE OINTMENT 30 5 69315-307-30 NYSTATIN 1 in 1 CARTON OINTMENT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-307 NYSTATIN OINTMENT [LEADING PHARMA, LLC] 5 Current NDC, Legacy NDC, 4 package rows 20191009_8900ba02-2c6a-4dd4-b82f-45620c06e255.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 69315-307-15 69315030715 1 TUBE in 1 CARTON (69315-307-15) / 15 g in 1 TUBE 1 tube 2019-08-19 0000-00-00 No No Current 69315-307-30 69315030730 1 TUBE in 1 CARTON (69315-307-30) / 30 g in 1 TUBE 1 tube 2019-08-19 0000-00-00 No No Current