Home NDC 66267-952 Nystatin
Product NDC 66267-952
11-digit product format 662670952
Labeler code 66267
Product ID 66267-952_1fa7bc90-f394-592a-e063-6394a90acab9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA064022
Marketing category ANDA
Marketing start 1993-01-28
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 8 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66267-952-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66267-952-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66267-952-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66267-952-30 1332a3947898…d4bfe170f9cd…
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 A064022-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064022-001 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 · 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 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g
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 543546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 66267-952-30 Nystatin 30 g in 1 BOX CREAM 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66267-952 NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240816_57825c04-dcb5-b76d-e053-2991aa0a4c1d.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 · 5 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 66267-952-30 66267095230 30 g in 1 BOX (66267-952-30) 30 g 2017-08-24 0000-00-00 No No Current