Home NDC 53489-400-01 Nystatin
Product NDC 53489-400
Requested package NDC 53489-400-01
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL 1988-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062838-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1988-12-22 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 53489-400-01 53489040001 100 TABLET, FILM COATED in 1 BOTTLE (53489-400-01) 1988-12-22 0000-00-00 No No Current