FDA.reportPublic FDA data

nystatin

Product NDC
23155-051
11-digit product format
231550051
Labeler code
23155
Product ID
23155-051_d5c4ffad-b502-4226-9ff2-8603aac88dba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-051-012024-01-30C16284748780-11030e365-5335-111a-e063-dadaa90a10e2Nystatin Tablets, USP (Oral) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-051-01nystatin100 in 1 BOTTLETABLET, COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-051-01EA - Each23155-0514085917d-e82a-4fb5-9eb4-f46d87d65f7f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-051NYSTATIN TABLET, COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20240525_e87b8480-987d-4f82-87bf-cf831d6984a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSNe87b8480-987d-4f82-87bf-cf831d6984a111
312059nystatin 500000 UNT Oral TabletSCDe87b8480-987d-4f82-87bf-cf831d6984a111
312059nystatin 500,000 UNT Oral TabletSYe87b8480-987d-4f82-87bf-cf831d6984a111
312059nystatin 500,000 UNT Oral TabletPSNa5711dbe-f71c-435c-91f2-38c357532d189
312059nystatin 500000 UNT Oral TabletSCDa5711dbe-f71c-435c-91f2-38c357532d189
312059nystatin 500,000 UNT Oral TabletSYa5711dbe-f71c-435c-91f2-38c357532d189
312059nystatin 500,000 UNT Oral TabletPSN04d795f3-aad7-4b79-8ebc-43c500afe39b2
312059nystatin 500,000 UNT Oral TabletPSN197e3046-3e58-4246-b260-f3995dce41a12
312059nystatin 500000 UNT Oral TabletSCD04d795f3-aad7-4b79-8ebc-43c500afe39b2
312059nystatin 500000 UNT Oral TabletSCD197e3046-3e58-4246-b260-f3995dce41a12
312059nystatin 500,000 UNT Oral TabletSY04d795f3-aad7-4b79-8ebc-43c500afe39b2
312059nystatin 500,000 UNT Oral TabletSY197e3046-3e58-4246-b260-f3995dce41a12
312059nystatin 500,000 UNT Oral TabletPSN05cc72dd-8e05-bfb5-e063-6394a90a92f11
312059nystatin 500000 UNT Oral TabletSCD05cc72dd-8e05-bfb5-e063-6394a90a92f11
312059nystatin 500,000 UNT Oral TabletSY05cc72dd-8e05-bfb5-e063-6394a90a92f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-051-0123155005101100 TABLET, COATED in 1 BOTTLE (23155-051-01) 2011-10-310000-00-00NoNoCurrent