Home NDC 75907-060 Nystatin
Product NDC 75907-060
11-digit product format 759070060
Labeler code 75907
Product ID 75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form POWDER
Route TOPICAL
Labeler Dr. Reddy's Labratories Inc.
Application ANDA065203
Marketing category ANDA
Marketing start 2024-05-28
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A065203-001 NYSTATIN NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065203-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065203-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT RS 2004-07-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 646456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75907-060-30 Nystatin 30 g in 1 BOTTLE, PLASTIC POWDER 30 1 75907-060-44 Nystatin 15 g in 1 BOTTLE, PLASTIC POWDER 15 1 75907-060-60 Nystatin 60 g in 1 BOTTLE, PLASTIC POWDER 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-060 NYSTATIN POWDER [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 3 package rows 20240528_6bde84a1-341d-09ce-58b6-f9a653dc98c5.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75907-060-30 75907006030 30 g in 1 BOTTLE, PLASTIC (75907-060-30) 30 g 2024-05-28 No No Current 75907-060-44 75907006044 15 g in 1 BOTTLE, PLASTIC (75907-060-44) 15 g 2024-05-28 No No Current 75907-060-60 75907006060 60 g in 1 BOTTLE, PLASTIC (75907-060-60) 60 g 2024-05-28 No No Current