FDA.reportPublic FDA data

NYSTATIN

Product NDC
69315-306
11-digit product format
693150306
Labeler code
69315
Product ID
69315-306_408ac13e-825a-44b1-b8cd-d52cbb0185d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
POWDER
Route
TOPICAL
Labeler
Leading Pharma, LLC
Application
ANDA208838
Marketing category
ANDA
Marketing start
2018-04-23
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208838-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2017-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208838-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208838-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2017-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208838-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINLeading Pharma, LLC089e6444-2bd1-443e-acf0-dfeaa69faef92024-04-18Exact identifier
application applno (ANDA): 208838
application number: ANDA208838
ndc (product): 69315-306

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
646456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
089e6444-2bd1-443e-acf0-dfeaa69faef9Available on FDA.report

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
69315-306-15NYSTATIN15 g in 1 BOTTLE, PLASTICPOWDER155
69315-306-30NYSTATIN30 g in 1 BOTTLE, PLASTICPOWDER305
69315-306-60NYSTATIN60 g in 1 BOTTLE, PLASTICPOWDER605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-306-15GM - Gram69315-306bfc4241a-8f2c-446c-af33-61487218ee6d12018-05-09
69315-306-30GM - Gram69315-306626322eb-727d-43ee-9421-13cb7344dfb012018-05-09
69315-306-60GM - Gram69315-30696a7dca3-3da5-41cf-8c86-89f8639df1ec12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-306NYSTATIN POWDER [LEADING PHARMA, LLC]5Current NDC, Legacy NDC, 3 package rows20240613_089e6444-2bd1-443e-acf0-dfeaa69faef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN089e6444-2bd1-443e-acf0-dfeaa69faef95
646456nystatin 100 UNT/MG Topical PowderSCD089e6444-2bd1-443e-acf0-dfeaa69faef95
646456nystatin 100,000 UNT/GM Topical PowderSY089e6444-2bd1-443e-acf0-dfeaa69faef95
646456nystatin 100,000 UNT/GM Topical PowderPSN1f338ee1-827d-daa1-e063-6394a90ad3f41
646456nystatin 100 UNT/MG Topical PowderSCD1f338ee1-827d-daa1-e063-6394a90ad3f41
646456nystatin 100,000 UNT/GM Topical PowderSY1f338ee1-827d-daa1-e063-6394a90ad3f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-306-156931503061515 g in 1 BOTTLE, PLASTIC (69315-306-15) 15 g2018-04-230000-00-00NoNoCurrent
69315-306-306931503063030 g in 1 BOTTLE, PLASTIC (69315-306-30) 30 g2018-04-230000-00-00NoNoCurrent
69315-306-606931503066060 g in 1 BOTTLE, PLASTIC (69315-306-60) 60 g2018-04-230000-00-00NoNoCurrent