Home NDC 68151-1487 Nystatin
Product NDC 68151-1487
11-digit product format 681511487
Labeler code 68151
Product ID 68151-1487_23972e7f-2313-4524-b554-b930e51fed92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carilion Materials Management
Application ANDA062506
Marketing category ANDA
Marketing start 1990-09-30
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 500000 [USP'U]/1
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag E
Listing certified through 2018-12-31
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 A062506-001 NYSTATIN NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062506-001 AA
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 A062506-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA RS 1984-01-16 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 A062506-001 AA 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 · 2 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 68151-1487-0 Nystatin 1 in 1 PACKAGE TABLET, FILM COATED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68151-1487 NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 3 Legacy NDC, 1 package rows 20140828_fc0cc939-3ad1-47f2-87b9-cdd91712e0db.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68151-1487-0 68151148700 1 in 1 PACKAGE Historical