Home NDC 17856-0508-7 NYSTATIN
Product NDC 17856-0508
Requested package NDC 17856-0508-7
11-digit product format 178560508
Labeler code 17856
Product ID 17856-0508_484acdef-5f40-bd3e-e063-6394a90aebe2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NYSTATIN
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
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 2027-12-31
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 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 2026-02-19 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# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
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 17856-0508-1 NYSTATIN 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 3 17856-0508-1 NYSTATIN 72 in 1 BOX, UNIT-DOSE SUSPENSION 72 3 17856-0508-3 NYSTATIN 5 mL in 1 SYRINGE SUSPENSION 5 3 17856-0508-3 NYSTATIN 48 in 1 BOX, UNIT-DOSE SUSPENSION 48 3 17856-0508-5 NYSTATIN 48 in 1 BOX, UNIT-DOSE SUSPENSION 48 3 17856-0508-5 NYSTATIN 5 mL in 1 SYRINGE SUSPENSION 5 3 17856-0508-7 NYSTATIN 1 mL in 1 SYRINGE SUSPENSION 1 3 17856-0508-7 NYSTATIN 120 in 1 BOX, UNIT-DOSE SUSPENSION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0508 NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 2 Current NDC, 8 package rows 20240719_5c08148f-83e5-4f14-b0d3-af8d2c26062e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17856-0508-7 17856050807 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-7) / 1 mL in 1 SYRINGE 120 syringe 2024-07-17 No No Current