Home NDC 0116-4026 Nystatin Oral Suspension
Product NDC 0116-4026
11-digit product format 001164026
Labeler code 0116
Product ID 0116-4026_4a2ff89a-52fe-8bf9-e063-6394a90a7f1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NYSTATIN
Dosage form SUSPENSION
Route ORAL
Labeler Xttrium Laboratories, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 2026-02-06
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 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 A062512-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062512-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin Oral Suspension
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 0116-4026-05 Nystatin Oral Suspension 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 1 0116-4026-11 Nystatin Oral Suspension 10 in 1 TRAY SUSPENSION 10 1 0116-4026-11 Nystatin Oral Suspension 10 in 1 CASE SUSPENSION 10 1 0116-4026-16 Nystatin Oral Suspension 473 mL in 1 BOTTLE, PLASTIC SUSPENSION 473 1 0116-4026-50 Nystatin Oral Suspension 10 in 1 TRAY SUSPENSION 10 1 0116-4026-50 Nystatin Oral Suspension 5 in 1 CASE SUSPENSION 5 1
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 · 2 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 0116-4026-05 00116402605 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0116-4026-11 00116402611 10 TRAY in 1 CASE (0116-4026-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) 10 tray 2026-02-06 No No Current 0116-4026-16 00116402616 473 mL in 1 BOTTLE, PLASTIC (0116-4026-16) 473 ml 2026-02-09 No No Current 0116-4026-50 00116402650 5 TRAY in 1 CASE (0116-4026-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05) 5 tray 2026-02-09 No No Current