FDA.reportPublic FDA data

Nystatin

Product NDC
68071-4293
11-digit product format
680714293
Labeler code
68071
Product ID
68071-4293_275d40f9-dd81-6741-e063-6294a90aece1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062225
Marketing category
ANDA
Marketing start
2006-09-21
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
A062225-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062225-001AT

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 22:54:322026-06A062225-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062225-001AT1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MycostatinNYSTATINDirect_Rxf1857ac0-806c-4a7e-e053-2995a90abbc02026-03-17Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINA-S Medication Solutionsf1b13a36-c349-4e26-a322-3ec02c6101552026-03-16Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINBryant Ranch Prepackb71356cf-7b6e-4ca0-9571-c80fd0d846cb2025-10-23Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINBryant Ranch Prepack840eebe8-5de2-40c5-acfd-03a98b2e790e2025-09-23Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINBryant Ranch Prepackcc8f9a06-cd1b-40e9-bc22-7e19f6d89b832025-04-02Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINNuCare Pharmaceuticals,Inc.6599b544-60bd-ab30-e053-2a91aa0a67b62024-11-20Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
ndc (product): 68071-4293
NystatinNYSTATINA-S Medication Solutionsf410ba07-9183-40a8-a2a6-46d3e97614702024-11-06Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINBryant Ranch Prepackb69d9035-bdf5-4c5a-94d8-f8438f6f05672024-08-27Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINNuCare Pharmaceuticals,Inc.86cfb84c-dcd3-b229-e053-2a91aa0aed5c2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltde630aa3d-11a6-4300-942a-cbdf2d016f772024-03-01Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225
NystatinNYSTATINProficient Rx LPe7f0e152-233a-492e-a297-7bf2c543c1132022-05-02Adverse reactionsExact identifier
application applno (ANDA): 062225
application number: ANDA062225

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
543546Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6599b544-60bd-ab30-e053-2a91aa0a67b6Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4293-32024-06-06C16284748780-1f386c649-d35b-0266-e053-dadaa90a7c1aNYSTATIN CREAM USP DRUG FACTS
68071-4293-32023-01-30C16284748780-1f386c649-d35b-0266-e053-dadaa90a7c1aNYSTATIN CREAM USP DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4293-3Nystatin30 g in 1 BOXCREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4293NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20241122_6599b544-60bd-ab30-e053-2a91aa0a67b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN6599b544-60bd-ab30-e053-2a91aa0a67b66
543546nystatin 100000 UNT/ML Topical CreamSCD6599b544-60bd-ab30-e053-2a91aa0a67b66
543546nystatin 100,000 UNT/GM Topical CreamSY6599b544-60bd-ab30-e053-2a91aa0a67b66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4293-36807142930330 g in 1 BOX (68071-4293-3) 30 g2018-02-200000-00-00NoNoCurrent