Home NDC 0603-1481 Nystatin
Product NDC 0603-1481
11-digit product format 006031481
Labeler code 0603
Product ID 0603-1481_2d6bac60-67d9-4b1b-a007-660ed3528b41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Par Pharmaceutical
Application ANDA065148
Marketing category ANDA
Marketing start 2005-06-28
Marketing end 2019-04-30
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 A065148-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065148-001 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 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 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 A065148-001 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 · 1 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [STAT RX USA LLC] 1 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [STAT RX USA LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [STAT RX USA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [STAT RX USA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [STAT RX USA LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [STAT RX USA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 312055 nystatin 100,000 UNT/mL Oral Suspension PSN e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100000 UNT/ML Oral Suspension SCD e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100,000 UNT/ML Oral Suspension SY e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1