FDA.reportPublic FDA data

Nystatin

Product NDC
0713-0686
11-digit product format
007130686
Labeler code
0713
Product ID
0713-0686_0b479d47-d58c-1457-e063-6394a90a1256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA209114
Marketing category
ANDA
Marketing start
2017-10-06
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
Rxcui884308

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
0713-0686-15Nystatin1 in 1 CARTONOINTMENT19
0713-0686-15Nystatin15 g in 1 TUBEOINTMENT159
0713-0686-31Nystatin30 g in 1 TUBEOINTMENT309
0713-0686-31Nystatin1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0686-15GM - Gram0713-06867ee7a313-49ed-4d46-8aba-2919385d623a12018-12-13
0713-0686-31GM - Gram0713-06869f558f27-0803-4dad-94a4-316b3faee4f912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0686NYSTATIN (NYSTATIN OINTMENT) OINTMENT [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20231130_8f87de59-33f2-32af-ae17-78bf30fb424d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100 UNT/MG Topical OintmentSCD8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100,000 UNT/GM Topical OintmentSY8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100,000 UNT/GM Topical OintmentPSN711950c4-1889-4acd-ab76-9a16176ce1e41
884308nystatin 100 UNT/MG Topical OintmentSCD711950c4-1889-4acd-ab76-9a16176ce1e41
884308nystatin 100,000 UNT/GM Topical OintmentSY711950c4-1889-4acd-ab76-9a16176ce1e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0686-15007130686151 TUBE in 1 CARTON (0713-0686-15) / 15 g in 1 TUBE1 tube2018-07-300000-00-00NoNoCurrent
0713-0686-31007130686311 TUBE in 1 CARTON (0713-0686-31) / 30 g in 1 TUBE1 tube2018-07-300000-00-00NoNoCurrent