Home NDC 0603-1481 Nystatin
Product NDC 0603-1481
11-digit product format 006031481
Labeler code 0603
Product ID 0603-1481_2d6bac60-67d9-4b1b-a007-660ed3528b41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Par Pharmaceutical
Application ANDA065148
Marketing category ANDA
Marketing start 2005-06-28
Marketing end 2019-04-30
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065148-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065148-001 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 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065148-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2005-06-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS, INC] 2 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [STAT RX USA LLC] 1 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [STAT RX USA LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [STAT RX USA LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [STAT RX USA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [STAT RX USA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [STAT RX USA LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [STAT RX USA LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [STAT RX USA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP] 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 · 1 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 e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100000 UNT/ML Oral Suspension SCD e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100,000 UNT/ML Oral Suspension SY e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY e73b5b84-7af5-4778-bcb3-71e573ce3c50 4 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100,000 UNT/mL Oral Suspension PSN 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100000 UNT/ML Oral Suspension SCD 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 100,000 UNT/ML Oral Suspension SY 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 29ccf947-91c1-405a-aba6-5889e3c75d70 1 312055 nystatin 500,000 UNT per 5 ML Oral Suspension SY 4c25ae58-c424-44c1-85e0-63b99ecd2ecb 1