Home NDC 42291-651 Nystatin
Product NDC 42291-651
11-digit product format 422910651
Labeler code 42291
Product ID 42291-651_3f165da9-403f-6f69-e063-6294a90a45bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA062506
Marketing category ANDA
Marketing start 2014-01-20
Substance NYSTATIN
Active strength 500000 [USP'U]/1
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 500000 [USP'U]/1
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 312059 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 42291-651-90 Nystatin 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-651 NYSTATIN TABLET, FILM COATED [AVKARE] 6 Current NDC, Legacy NDC, 1 package rows 20240111_8fd35f97-5405-2160-ca0f-35034ecd5a92.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42291-651-90 42291065190 90 TABLET, FILM COATED in 1 BOTTLE (42291-651-90) 2014-01-20 0000-00-00 No No Current