Home NDC 53002-8220-1 Nystatin
Product NDC 53002-8220
Requested package NDC 53002-8220-1
11-digit product format 530028220
Labeler code 53002
Product ID 53002-8220_55187fff-7448-40e7-bbc0-a665f0017ed0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form OINTMENT
Route TOPICAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA062472
Marketing category ANDA
Marketing start 2006-09-15
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A062472-001 NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062472-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062472-001 NYSTATIN 100,000 UNITS/GM OINTMENT / TOPICAL AT 1984-02-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-8220-1 Nystatin 15 g in 1 TUBE OINTMENT 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-8220 NYSTATIN OINTMENT [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 1 package rows 20230609_0ee89f89-e90d-4706-9fa5-a61b5fde4470.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53002-8220-1 53002822001 15 g in 1 TUBE (53002-8220-1) 15 g 2018-10-01 0000-00-00 No No Current