Home NDC 17856-0508-3 NYSTATIN
Product NDC 17856-0508
Requested package NDC 17856-0508-3
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# 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
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 17856-0508-3 17856050803 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0508-3) / 5 mL in 1 SYRINGE 48 syringe 2024-07-17 No No Current