Home NDC 0121-4785 Nystatin
Product NDC 0121-4785
11-digit product format 001214785
Labeler code 0121
Product ID 0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 2009-06-01
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 2019-12-31
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.
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 [PHARMACEUTICAL ASSOCIATES, INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 POTASSIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2