Home NDC 50383-587-66 Nystatin
Product NDC 50383-587
Requested package NDC 50383-587-66
11-digit product format 503830587
Labeler code 50383
Product ID 50383-587_0345456c-d63b-4692-9640-f7aae6171ad7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Akorn
Application ANDA064042
Marketing category ANDA
Marketing start 2012-01-27
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 A064042-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1994-02-28
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 A064042-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1994-02-28 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [HI-TECH PHARMACAL CO., INC.] 2 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1
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 50383-587-66 50383058766 1 BOTTLE, DROPPER in 1 CARTON (50383-587-66) > 60 mL in 1 BOTTLE, DROPPER 2012-01-27 0000-00-00 No No Current