FDA.reportPublic FDA data

nystatin

Product NDC
71205-575
11-digit product format
712050575
Labeler code
71205
Product ID
71205-575_98364393-50d2-4479-9048-8095cfa7a290
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062474
Marketing category
ANDA
Marketing start
2011-10-31
Substance
NYSTATIN
Active strength
500000 [USP'U]/1
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
NYSTATIN500000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312059

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71205-575-30nystatin30 in 1 BOTTLETABLET, COATED302
71205-575-60nystatin60 in 1 BOTTLETABLET, COATED602
71205-575-90nystatin90 in 1 BOTTLETABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-575-30EA - Each71205-57558b4faeb-a198-4c92-8e2e-df8596001a9612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-575NYSTATIN TABLET, COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20210825_04d795f3-aad7-4b79-8ebc-43c500afe39b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSN04d795f3-aad7-4b79-8ebc-43c500afe39b2
312059nystatin 500000 UNT Oral TabletSCD04d795f3-aad7-4b79-8ebc-43c500afe39b2
312059nystatin 500,000 UNT Oral TabletSY04d795f3-aad7-4b79-8ebc-43c500afe39b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-575-307120505753030 TABLET, COATED in 1 BOTTLE (71205-575-30) 2021-06-080000-00-00NoNoCurrent
71205-575-607120505756060 TABLET, COATED in 1 BOTTLE (71205-575-60) 2021-06-080000-00-00NoNoCurrent
71205-575-907120505759090 TABLET, COATED in 1 BOTTLE (71205-575-90) 2021-06-080000-00-00NoNoCurrent