Home NDC 64950-230 Nystatin
Product NDC 64950-230
11-digit product format 649500230
Labeler code 64950
Product ID 64950-230_f4bb764f-297f-4b7a-bf57-0e43e236c2ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Genus Lifescience Inc.
Application ANDA065422
Marketing category ANDA
Marketing start 2014-04-01
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/15mL
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 .
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 2022-04-08 23:34 UTC 2022-04 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065422-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Sodium Phosphate, Dibasic, Anhydrous INACTIVE INGREDIENT 22ADO53M6F NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Sodium Phosphate, Monobasic INACTIVE INGREDIENT 3980JIH2SW NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [LEHIGH VALLEY TECHNOLOGIES, INC.] 1