FDA.reportPublic FDA data

NYSTATIN

Product NDC
72189-046
11-digit product format
721890046
Labeler code
72189
Product ID
72189-046_92ab6d9a-f63a-226a-e053-2a95a90a731f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Direct_Rx
Application
ANDA061966
Marketing category
ANDA
Marketing start
2019-09-16
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72189-046IInactivated by FDA2026-08-03
excluded packagepackage72189-04672189-046-15IInactivated by FDA2026-08-03

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
A061966-001NYSTATINNYSTATIN100,000 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
A061966-001AT

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 22:54:322026-06A061966-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A061966-001AT1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINA-S Medication Solutions98bd8ccb-0c68-47b9-bcb4-c5d8217868d92026-07-24Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMNuCare Pharmaceuticals, Inc.42f21220-c68a-d748-e063-6394a90a1e2f2025-11-06Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATINA-S Medication Solutionsa1b5ccb2-d0d6-46cc-b792-6920b50d0a032025-05-15Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMCosette Pharmaceuticals, Inc.ec1b52af-d38e-eba1-e63c-dba4341d3af22022-11-22Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMProficient Rx LPb1efcc2c-f71a-463d-9a02-fad7550f31ec2022-11-01Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966

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
72189-046-152023-01-30C16284748780-1f386c649-ebb8-0266-e053-dadaa90a7c1aNYSTATIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-046-15NYSTATIN1 g in 1 TUBECREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-046-15GM - Gram72189-046f44f71d1-ba07-4c88-8d4d-78d4a9573b0d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-046NYSTATIN CREAM [DIRECT_RX]1Legacy NDC, 1 package rows20191010_92ab6d9a-f639-226a-e053-2a95a90a731f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN92ab6d9a-f639-226a-e053-2a95a90a731f1
543546nystatin 100000 UNT/ML Topical CreamSCD92ab6d9a-f639-226a-e053-2a95a90a731f1
543546nystatin 100,000 UNT/GM Topical CreamSY92ab6d9a-f639-226a-e053-2a95a90a731f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-046-15721890046151 g in 1 TUBE (72189-046-15) 1 g2019-09-160000-00-00NoNoCurrent