FDA.reportPublic FDA data

NDC 70771-1585-01 - NYSTATIN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70771-1585
Requested NDC
70771-1585-01
Package NDCs from labels
70771-1585-1, 70771-1585-3, 70771-1585-2, 70771-1585-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NYSTATIN - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-12-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1585-1NYSTATIN15 g in 1 BOTTLE, PLASTICPOWDER155
70771-1585-2NYSTATIN30 g in 1 BOTTLE, PLASTICPOWDER305
70771-1585-3NYSTATIN60 g in 1 BOTTLE, PLASTICPOWDER605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1585NYSTATIN POWDER [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 3 package rows20241206_5d593aa9-f2e4-4adf-9f02-37832ffcb5b4.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 4 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltd6c091c66-2e4d-4412-b7bf-35315dc8152f2025-01-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.6115a76d-4bad-4829-b2bc-3a077154109d2025-01-20Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINNuCare Pharmaceuticals,Inc.0b4dfd5e-641e-40e9-e063-6294a90a3fda2025-01-03Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINZydus Lifesciences Limited5d593aa9-f2e4-4adf-9f02-37832ffcb5b42024-12-03Exact identifier
application number: ANDA208581
ndc (package): 70771-1585-1
ndc (package): 70771-1585-2
ndc (package): 70771-1585-3
ndc (product): 70771-1585
ndc11 (package): 70771158501
rxcui: 646456
spl id: ea55d8af-28a2-491e-8aae-aa5102c228aa
spl set id: 5d593aa9-f2e4-4adf-9f02-37832ffcb5b4
unii: BDF1O1C72E
NYSTATINNYSTATINLeading Pharma, LLC954205d8-47ba-4c89-95cd-f0066a514cf92024-11-28Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.6599b544-60bd-ab30-e053-2a91aa0a67b62024-11-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackec28a12b-96f8-44ff-a440-8cff34ac20952024-11-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutionsf410ba07-9183-40a8-a2a6-46d3e97614702024-11-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINPadagis US LLCe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f2024-10-31Adverse reactionsExact identifier
rxcui: 646456
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutions65167baa-29f8-44d3-b2d2-935c862d463e2024-10-16Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.c8beaa42-eb3a-d160-e053-2a95a90a31082024-10-03Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepackb69d9035-bdf5-4c5a-94d8-f8438f6f05672024-08-27Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackb3056a63-d149-4ed4-84bc-918f5ff94a622024-08-22Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc62979d3-c9a4-4d94-956e-30760266daf42024-08-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEZydus Lifesciences Limited7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f2024-08-16Exact identifier
unii: BDF1O1C72E
NystatinNYSTATINZydus Lifesciences Limited6aa2f67e-9636-45e5-be1b-83e7ab86e4362024-08-16Exact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.86cfb84c-dcd3-b229-e053-2a91aa0aed5c2024-08-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack92b08b14-a933-454b-8b6f-4b5e7c6829532024-08-06Adverse reactionsExact identifier
unii: BDF1O1C72E

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.