Home NDC 63629-8521 Nystatin
Product NDC 63629-8521
11-digit product format 636298521
Labeler code 63629
Product ID 63629-8521_6dcbeff0-db0e-44b9-b31c-5e4374a4a760
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA065422
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-8521-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-8521-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-8521-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-8521-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-8521-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-8521-1 cdf11ea48f46…ba0047e9e063…
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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8521-1 63629852101 60 mL in 1 BOTTLE (63629-8521-1) 60 ml 2021-05-19 0000-00-00 No No Current