Home NDC 68788-8561 NYSTATIN
Product NDC 68788-8561
11-digit product format 687888561
Labeler code 68788
Product ID 68788-8561_22fc2dd7-78fc-497b-84e2-96ec602eec21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NYSTATIN
Dosage form SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA214346
Marketing category ANDA
Marketing start 2024-01-08
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 2027-12-31 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 68788-8561-4 NYSTATIN 473 mL in 1 BOTTLE SUSPENSION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8561 NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20240206_8211a0ef-98a8-4136-986c-23c306db1159.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8561-4 68788856104 473 mL in 1 BOTTLE (68788-8561-4) 473 ml 2024-01-08 No No Current