FDA.reportPublic FDA data

Nystatin

Product NDC
0713-0678
11-digit product format
007130678
Labeler code
0713
Product ID
0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA061966
Marketing category
ANDA
Marketing start
2015-04-01
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
Nystatin
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui543546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
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
0713-0678-15Nystatin1 in 1 CARTONCREAM17
0713-0678-15Nystatin15 g in 1 TUBECREAM157
0713-0678-31Nystatin30 g in 1 TUBECREAM307
0713-0678-31Nystatin1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0678-15GM - Gram0713-0678494ee12e-ed55-4bd6-b599-87ec42adb82c12015-12-02
0713-0678-31GM - Gram0713-0678e7e9b75f-f0d8-4eb6-bec4-3a073f40bf3612015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
AlgeldrateINACTIVE INGREDIENT03J11K103CNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Ceteareth-15INACTIVE INGREDIENT867H4YOZ8ZNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
DimethiconeINACTIVE INGREDIENT92RU3N3Y1ONYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
PetrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
SorbitolINACTIVE INGREDIENT506T60A25RNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RNYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0678NYSTATIN (NYSTATIN CREAM) CREAM [COSETTE PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20221123_ec1b52af-d38e-eba1-e63c-dba4341d3af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNa1b5ccb2-d0d6-46cc-b792-6920b50d0a0310
543546nystatin 100000 UNT/ML Topical CreamSCDa1b5ccb2-d0d6-46cc-b792-6920b50d0a0310
543546nystatin 100,000 UNT/GM Topical CreamSYa1b5ccb2-d0d6-46cc-b792-6920b50d0a0310
543546nystatin 100,000 UNT/GM Topical CreamPSNec1b52af-d38e-eba1-e63c-dba4341d3af27
543546nystatin 100000 UNT/ML Topical CreamSCDec1b52af-d38e-eba1-e63c-dba4341d3af27
543546nystatin 100,000 UNT/GM Topical CreamSYec1b52af-d38e-eba1-e63c-dba4341d3af27
543546nystatin 100,000 UNT/GM Topical CreamPSN92ab6d9a-f639-226a-e053-2a95a90a731f1
543546nystatin 100,000 UNT/GM Topical CreamPSN42f21220-c68a-d748-e063-6394a90a1e2f1
543546nystatin 100,000 UNT/GM Topical CreamPSNda44d87a-159e-24d4-e053-2a95a90a09d91
543546nystatin 100,000 UNT/GM Topical CreamPSNb1efcc2c-f71a-463d-9a02-fad7550f31ec1
543546nystatin 100,000 UNT/GM Topical CreamPSN98bd8ccb-0c68-47b9-bcb4-c5d8217868d91
543546nystatin 100000 UNT/ML Topical CreamSCD42f21220-c68a-d748-e063-6394a90a1e2f1
543546nystatin 100000 UNT/ML Topical CreamSCDb1efcc2c-f71a-463d-9a02-fad7550f31ec1
543546nystatin 100000 UNT/ML Topical CreamSCDda44d87a-159e-24d4-e053-2a95a90a09d91
543546nystatin 100000 UNT/ML Topical CreamSCD98bd8ccb-0c68-47b9-bcb4-c5d8217868d91
543546nystatin 100000 UNT/ML Topical CreamSCD92ab6d9a-f639-226a-e053-2a95a90a731f1
543546nystatin 100,000 UNT/GM Topical CreamSY42f21220-c68a-d748-e063-6394a90a1e2f1
543546nystatin 100,000 UNT/GM Topical CreamSYb1efcc2c-f71a-463d-9a02-fad7550f31ec1
543546nystatin 100,000 UNT/GM Topical CreamSY92ab6d9a-f639-226a-e053-2a95a90a731f1
543546nystatin 100,000 UNT/GM Topical CreamSYda44d87a-159e-24d4-e053-2a95a90a09d91
543546nystatin 100,000 UNT/GM Topical CreamSY98bd8ccb-0c68-47b9-bcb4-c5d8217868d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0678-15007130678151 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE1 tube2015-04-010000-00-00NoNoCurrent
0713-0678-31007130678311 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE1 tube2015-04-010000-00-00NoNoCurrent