Home NDC 68094-599-61 Nystatin
Product NDC 68094-599
Requested package NDC 68094-599-61
11-digit product format 680940599
Labeler code 68094
Product ID 68094-599_c5e09aec-bb6a-4a07-b34d-745c94092f2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 2005-12-15
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 500000 [USP'U]/5mL
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 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 [CARDINAL HEALTH] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [CARDINAL HEALTH] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68094-599-61 68094059961 10 TRAY in 1 CASE (68094-599-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-599-59) 10 tray 2005-12-15 0000-00-00 No No Current