Home NDC 69315-504 NYSTATIN
Product NDC 69315-504
11-digit product format 693150504
Labeler code 69315
Product ID 69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NYSTATIN
Dosage form SUSPENSION
Route ORAL
Labeler Leading Pharma, LLC
Application ANDA214346
Marketing category ANDA
Marketing start 2022-12-05
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
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 42 .
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 A214346-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214346-001 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 2026-08-18 06:07:40 2026-07 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2022-03-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214346-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 2022-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base NYSTATIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/mL
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 312055 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69315-504-47 NYSTATIN 473 mL in 1 BOTTLE SUSPENSION 473 5 69315-504-60 NYSTATIN 60 mL in 1 BOTTLE SUSPENSION 60 5 69315-504-60 NYSTATIN 1 in 1 PACKAGE SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-504 NYSTATIN SUSPENSION [LEADING PHARMA, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20241129_954205d8-47ba-4c89-95cd-f0066a514cf9.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 · 4 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 954205d8-47ba-4c89-95cd-f0066a514cf9 5 312055 nystatin 100000 UNT/ML Oral Suspension SCD 954205d8-47ba-4c89-95cd-f0066a514cf9 5 312055 nystatin 100,000 UNT/ML Oral Suspension SY 954205d8-47ba-4c89-95cd-f0066a514cf9 5 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 954205d8-47ba-4c89-95cd-f0066a514cf9 5 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 5c08148f-83e5-4f14-b0d3-af8d2c26062e 3 312055 nystatin 100000 UNT/ML Oral Suspension SCD 5c08148f-83e5-4f14-b0d3-af8d2c26062e 3 312055 nystatin 100,000 UNT/ML Oral Suspension SY 5c08148f-83e5-4f14-b0d3-af8d2c26062e 3 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 5c08148f-83e5-4f14-b0d3-af8d2c26062e 3 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 0b4dfd5e-641e-40e9-e063-6294a90a3fda 2 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 8211a0ef-98a8-4136-986c-23c306db1159 2 312055 nystatin 100000 UNT/ML Oral Suspension SCD 8211a0ef-98a8-4136-986c-23c306db1159 2 312055 nystatin 100000 UNT/ML Oral Suspension SCD 0b4dfd5e-641e-40e9-e063-6294a90a3fda 2 312055 nystatin 100,000 UNT/ML Oral Suspension SY 8211a0ef-98a8-4136-986c-23c306db1159 2 312055 nystatin 100,000 UNT/ML Oral Suspension SY 0b4dfd5e-641e-40e9-e063-6294a90a3fda 2 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 0b4dfd5e-641e-40e9-e063-6294a90a3fda 2 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 8211a0ef-98a8-4136-986c-23c306db1159 2 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 8a28274b-8165-4cf5-aae5-51fbf8215916 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 8a28274b-8165-4cf5-aae5-51fbf8215916 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 8a28274b-8165-4cf5-aae5-51fbf8215916 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 8a28274b-8165-4cf5-aae5-51fbf8215916 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69315-504-47 69315050447 473 mL in 1 BOTTLE (69315-504-47) 473 ml 2022-12-05 0000-00-00 No No Current 69315-504-60 69315050460 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE 1 bottle 2022-12-05 0000-00-00 No No Current