FDA.reportPublic FDA data

Nystop

Product NDC
0574-2008
11-digit product format
005742008
Labeler code
0574
Product ID
0574-2008_ef93a977-5107-4b0b-8d58-df221d7777db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Padagis US LLC
Application
ANDA064118
Marketing category
ANDA
Marketing start
1996-08-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nystop
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui261178, 646456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-2008-02Nystop60 g in 1 BOTTLE, PLASTICPOWDER6010
0574-2008-15Nystop15 g in 1 BOTTLE, PLASTICPOWDER1510
0574-2008-30Nystop30 g in 1 BOTTLE, PLASTICPOWDER3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2008-02GM - Gram0574-2008b7bcc8d2-ac76-46de-b962-e1afeee6ef1c12012-07-24
0574-2008-15GM - Gram0574-20085528b95e-853e-4f08-8147-2457c4bd593912012-07-24
0574-2008-30GM - Gram0574-20087f420756-0bf8-40a9-8601-9a9c652f030f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTOP (NYSTATIN) POWDER [PADDOCK LABORATORIES, LLC]6
NystatinACTIVE MOIETYBDF1O1C72ENYSTOP (NYSTATIN) POWDER [PADDOCK LABORATORIES, LLC]6
TalcINACTIVE INGREDIENT7SEV7J4R1UNYSTOP (NYSTATIN) POWDER [PADDOCK LABORATORIES, LLC]6
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN POWDER [PHYSICIANS TOTAL CARE, INC.]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN POWDER [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN POWDER [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-2008NYSTOP (NYSTATIN) POWDER [PADAGIS US LLC]9Current NDC, Legacy NDC, 3 package rows20230928_e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN69ebb4dd-f45d-448d-97cd-3f8935493975106
261178NYSTOP 100,000 UNT/GM Topical PowderPSN69ebb4dd-f45d-448d-97cd-3f8935493975106
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD69ebb4dd-f45d-448d-97cd-3f8935493975106
646456nystatin 100 UNT/MG Topical PowderSCD69ebb4dd-f45d-448d-97cd-3f8935493975106
646456nystatin 100,000 UNT/GM Topical PowderSY69ebb4dd-f45d-448d-97cd-3f8935493975106
261178Nystop 100 UNT/MG Topical PowderSY69ebb4dd-f45d-448d-97cd-3f8935493975106
261178Nystop 100,000 UNT/GM Topical PowderSY69ebb4dd-f45d-448d-97cd-3f8935493975106
646456nystatin 100,000 UNT/GM Topical PowderPSN87175864-9877-4e80-b870-907abb8ac289105
261178NYSTOP 100,000 UNT/GM Topical PowderPSN87175864-9877-4e80-b870-907abb8ac289105
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD87175864-9877-4e80-b870-907abb8ac289105
646456nystatin 100 UNT/MG Topical PowderSCD87175864-9877-4e80-b870-907abb8ac289105
646456nystatin 100,000 UNT/GM Topical PowderSY87175864-9877-4e80-b870-907abb8ac289105
261178Nystop 100 UNT/MG Topical PowderSY87175864-9877-4e80-b870-907abb8ac289105
261178Nystop 100,000 UNT/GM Topical PowderSY87175864-9877-4e80-b870-907abb8ac289105
646456nystatin 100,000 UNT/GM Topical PowderPSN5bce98a3-2964-4edc-b8da-8a46dafadf5e104
261178NYSTOP 100,000 UNT/GM Topical PowderPSN5bce98a3-2964-4edc-b8da-8a46dafadf5e104
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD5bce98a3-2964-4edc-b8da-8a46dafadf5e104
646456nystatin 100 UNT/MG Topical PowderSCD5bce98a3-2964-4edc-b8da-8a46dafadf5e104
646456nystatin 100,000 UNT/GM Topical PowderSY5bce98a3-2964-4edc-b8da-8a46dafadf5e104
261178Nystop 100 UNT/MG Topical PowderSY5bce98a3-2964-4edc-b8da-8a46dafadf5e104
261178Nystop 100,000 UNT/GM Topical PowderSY5bce98a3-2964-4edc-b8da-8a46dafadf5e104
646456nystatin 100,000 UNT/GM Topical PowderPSN0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178NYSTOP 100,000 UNT/GM Topical PowderPSN0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD0bb31239-fb77-442a-a9ee-ba61b45e7e68102
646456nystatin 100 UNT/MG Topical PowderSCD0bb31239-fb77-442a-a9ee-ba61b45e7e68102
646456nystatin 100,000 UNT/GM Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178Nystop 100 UNT/MG Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102
261178Nystop 100,000 UNT/GM Topical PowderSY0bb31239-fb77-442a-a9ee-ba61b45e7e68102
646456nystatin 100,000 UNT/GM Topical PowderPSN64041bdf-1207-47f6-93f3-bc4656a7d2ae100
646456nystatin 100,000 UNT/GM Topical PowderPSNaffea013-4f09-4e7d-a696-9f501d379af6100
261178NYSTOP 100,000 UNT/GM Topical PowderPSNaffea013-4f09-4e7d-a696-9f501d379af6100
261178NYSTOP 100,000 UNT/GM Topical PowderPSN64041bdf-1207-47f6-93f3-bc4656a7d2ae100
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBDaffea013-4f09-4e7d-a696-9f501d379af6100
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD64041bdf-1207-47f6-93f3-bc4656a7d2ae100
646456nystatin 100 UNT/MG Topical PowderSCD64041bdf-1207-47f6-93f3-bc4656a7d2ae100
646456nystatin 100 UNT/MG Topical PowderSCDaffea013-4f09-4e7d-a696-9f501d379af6100
646456nystatin 100,000 UNT/GM Topical PowderSY64041bdf-1207-47f6-93f3-bc4656a7d2ae100
646456nystatin 100,000 UNT/GM Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100
261178Nystop 100 UNT/MG Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100
261178Nystop 100 UNT/MG Topical PowderSY64041bdf-1207-47f6-93f3-bc4656a7d2ae100
261178Nystop 100,000 UNT/GM Topical PowderSY64041bdf-1207-47f6-93f3-bc4656a7d2ae100
261178Nystop 100,000 UNT/GM Topical PowderSYaffea013-4f09-4e7d-a696-9f501d379af6100
646456nystatin 100,000 UNT/GM Topical PowderPSNe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
261178NYSTOP 100,000 UNT/GM Topical PowderPSNe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBDe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
646456nystatin 100 UNT/MG Topical PowderSCDe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
646456nystatin 100,000 UNT/GM Topical PowderSYe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
261178Nystop 100 UNT/MG Topical PowderSYe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
261178Nystop 100,000 UNT/GM Topical PowderSYe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f10
646456nystatin 100,000 UNT/GM Topical PowderPSNd62d9d90-3ef2-4697-b6d5-bdb8923949981
646456nystatin 100,000 UNT/GM Topical PowderPSN962c48af-3e45-4e1b-93f7-ae99a6a14ec71
261178NYSTOP 100,000 UNT/GM Topical PowderPSN962c48af-3e45-4e1b-93f7-ae99a6a14ec71
261178nystatin 100 UNT/MG Topical Powder [Nystop]SBD962c48af-3e45-4e1b-93f7-ae99a6a14ec71
646456nystatin 100 UNT/MG Topical PowderSCDd62d9d90-3ef2-4697-b6d5-bdb8923949981
646456nystatin 100 UNT/MG Topical PowderSCD962c48af-3e45-4e1b-93f7-ae99a6a14ec71
646456nystatin 100,000 UNT/GM Topical PowderSYd62d9d90-3ef2-4697-b6d5-bdb8923949981
646456nystatin 100,000 UNT/GM Topical PowderSY962c48af-3e45-4e1b-93f7-ae99a6a14ec71
261178Nystop 100 UNT/MG Topical PowderSY962c48af-3e45-4e1b-93f7-ae99a6a14ec71
261178Nystop 100,000 UNT/GM Topical PowderSY962c48af-3e45-4e1b-93f7-ae99a6a14ec71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-2008-020057420080260 g in 1 BOTTLE, PLASTIC (0574-2008-02) 60 g1996-08-160000-00-00NoNoCurrent
0574-2008-150057420081515 g in 1 BOTTLE, PLASTIC (0574-2008-15) 15 g1996-08-160000-00-00NoNoCurrent
0574-2008-300057420083030 g in 1 BOTTLE, PLASTIC (0574-2008-30) 30 g1996-08-160000-00-00NoNoCurrent