Home NDC 60432-537 Nystatin
Product NDC 60432-537
11-digit product format 604320537
Labeler code 60432
Product ID 60432-537_ae3ecbaa-1371-4b51-8abd-3a583c0de11b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 1995-04-15
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 2020-12-31
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 A062512-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062512-001 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 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 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 A062512-001 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 potassium phosphate, dibasic INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 3 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 potassium phosphate, dibasic INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 potassium phosphate, dibasic INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 POTASSIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 potassium phosphate, dibasic INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-537 NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Legacy NDC 20190124_d468395c-0f4c-4503-9a39-ae847524e683.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 312055 nystatin 100,000 UNT/mL Oral Suspension PSN e069d495-7f1a-4970-8f4d-aa93d124b3fc 9 312055 nystatin 100000 UNT/ML Oral Suspension SCD e069d495-7f1a-4970-8f4d-aa93d124b3fc 9 312055 nystatin 100,000 UNT/ML Oral Suspension SY e069d495-7f1a-4970-8f4d-aa93d124b3fc 9 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY e069d495-7f1a-4970-8f4d-aa93d124b3fc 9 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 19af50e2-0535-44f4-8b31-49e0bfe6a415 1 312055 nystatin 100,000 UNT/mL Oral Suspension PSN ceb0fc2d-9039-4961-84b6-ceb2a2649c50 1 312055 nystatin 100,000 UNT/mL Oral Suspension PSN f7a98d15-ce46-4358-ac6e-d10afa4d34c2 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 19af50e2-0535-44f4-8b31-49e0bfe6a415 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD ceb0fc2d-9039-4961-84b6-ceb2a2649c50 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD f7a98d15-ce46-4358-ac6e-d10afa4d34c2 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 19af50e2-0535-44f4-8b31-49e0bfe6a415 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY ceb0fc2d-9039-4961-84b6-ceb2a2649c50 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY f7a98d15-ce46-4358-ac6e-d10afa4d34c2 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 19af50e2-0535-44f4-8b31-49e0bfe6a415 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY ceb0fc2d-9039-4961-84b6-ceb2a2649c50 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY f7a98d15-ce46-4358-ac6e-d10afa4d34c2 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60432-537-16 60432053716 473 mL in 1 BOTTLE, PLASTIC (60432-537-16) 473 ml 1995-04-15 0000-00-00 No No Current 60432-537-60 60432053760 60 mL in 1 BOTTLE, GLASS (60432-537-60) 60 ml 1995-04-15 0000-00-00 No No Current