Home NDC 23155-051 nystatin
Product NDC 23155-051
11-digit product format 231550051
Labeler code 23155
Product ID 23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nystatin
Dosage form TABLET, COATED
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA062474
Marketing category ANDA
Marketing start 2011-10-31
Substance NYSTATIN
Active strength 500000 [USP'U]/1
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A062474-001 NYSTATIN NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062474-001 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.
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 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062474-001 NYSTATIN 500,000 UNITS TABLET / ORAL AA 1983-12-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 500000 [USP'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 23155-051-01 nystatin 100 in 1 BOTTLE TABLET, COATED 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-051 NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240525_e87b8480-987d-4f82-87bf-cf831d6984a1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 312059 nystatin 500,000 UNT Oral Tablet PSN e87b8480-987d-4f82-87bf-cf831d6984a1 11 312059 nystatin 500000 UNT Oral Tablet SCD e87b8480-987d-4f82-87bf-cf831d6984a1 11 312059 nystatin 500,000 UNT Oral Tablet SY e87b8480-987d-4f82-87bf-cf831d6984a1 11 312059 nystatin 500,000 UNT Oral Tablet PSN a5711dbe-f71c-435c-91f2-38c357532d18 9 312059 nystatin 500000 UNT Oral Tablet SCD a5711dbe-f71c-435c-91f2-38c357532d18 9 312059 nystatin 500,000 UNT Oral Tablet SY a5711dbe-f71c-435c-91f2-38c357532d18 9 312059 nystatin 500,000 UNT Oral Tablet PSN 04d795f3-aad7-4b79-8ebc-43c500afe39b 2 312059 nystatin 500,000 UNT Oral Tablet PSN 197e3046-3e58-4246-b260-f3995dce41a1 2 312059 nystatin 500000 UNT Oral Tablet SCD 04d795f3-aad7-4b79-8ebc-43c500afe39b 2 312059 nystatin 500000 UNT Oral Tablet SCD 197e3046-3e58-4246-b260-f3995dce41a1 2 312059 nystatin 500,000 UNT Oral Tablet SY 04d795f3-aad7-4b79-8ebc-43c500afe39b 2 312059 nystatin 500,000 UNT Oral Tablet SY 197e3046-3e58-4246-b260-f3995dce41a1 2 312059 nystatin 500,000 UNT Oral Tablet PSN 05cc72dd-8e05-bfb5-e063-6394a90a92f1 1 312059 nystatin 500000 UNT Oral Tablet SCD 05cc72dd-8e05-bfb5-e063-6394a90a92f1 1 312059 nystatin 500,000 UNT Oral Tablet SY 05cc72dd-8e05-bfb5-e063-6394a90a92f1 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 23155-051-01 23155005101 100 TABLET, COATED in 1 BOTTLE (23155-051-01) 2011-10-31 0000-00-00 No No Current