Home NDC 53489-400-05 Nystatin
Product NDC 53489-400
Requested package NDC 53489-400-05
11-digit product format 534890400
Labeler code 53489
Product ID 53489-400_2628bf08-c7f5-4aef-8e14-bf987eca87ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA062838
Marketing category ANDA
Marketing start 1988-12-22
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 500000 [USP'U]/1
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 A062838-001 NYSTATIN NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22
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 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 hydroxypropyl cellulose (type H) INACTIVE INGREDIENT RFW2ET671P NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 povidones INACTIVE INGREDIENT FZ989GH94E NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 starch, potato INACTIVE INGREDIENT 8I089SAH3T NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 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 53489-400-05 53489040005 500 TABLET, FILM COATED in 1 BOTTLE (53489-400-05) 1988-12-22 0000-00-00 No No Current