FDA.reportPublic FDA data

Nystatin

Product NDC
43386-530
11-digit product format
433860530
Labeler code
43386
Product ID
43386-530_b0de02c7-980a-4947-ae03-f5ef52a4b06f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA065138
Marketing category
ANDA
Marketing start
2014-09-26
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43386-530EExcluded after deficient or non-compliant submission was not corrected2026-07-31
excluded packagepackage43386-53043386-530-01EExcluded after deficient or non-compliant submission was not corrected2026-07-31
excluded packagepackage43386-53043386-530-02EExcluded after deficient or non-compliant submission was not corrected2026-07-31
excluded packagepackage43386-53043386-530-06EExcluded after deficient or non-compliant submission was not corrected2026-07-31

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
A065138-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065138-001AT

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 22:54:322026-06A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065138-001AT1a50c72e98297…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-530-01Nystatin15 g in 1 BOTTLE, PLASTICPOWDER154
43386-530-02Nystatin30 g in 1 BOTTLE, PLASTICPOWDER304
43386-530-05Nystatin56.7 g in 1 BOTTLE, PLASTICPOWDER56.74
43386-530-06Nystatin60 g in 1 BOTTLE, PLASTICPOWDER604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-530-01GM - Gram43386-530c5f6d864-6e63-4254-ad2a-475cf4289f1412014-10-03
43386-530-02GM - Gram43386-5300a85ea37-23e7-4448-9483-f3699ce0824612014-10-03
43386-530-06GM - Gram43386-5300d1a59c2-ee22-4271-bd81-0a3f8a127f4012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN POWDER [GAVIS PHARMACEUTICALS, LLC.]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN POWDER [GAVIS PHARMACEUTICALS, LLC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN POWDER [GAVIS PHARMACEUTICALS, LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-530NYSTATIN POWDER [LUPIN PHARMACEUTICALS,INC.]4Legacy NDC, 4 package rows20240131_cf863efe-53d7-4654-94fc-6530ecdff921.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSNcf863efe-53d7-4654-94fc-6530ecdff9214
646456nystatin 100 UNT/MG Topical PowderSCDcf863efe-53d7-4654-94fc-6530ecdff9214
646456nystatin 100,000 UNT/GM Topical PowderSYcf863efe-53d7-4654-94fc-6530ecdff9214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-530-014338605300115 g in 1 BOTTLE, PLASTIC (43386-530-01) 15 g2014-09-260000-00-00NoNoCurrent
43386-530-024338605300230 g in 1 BOTTLE, PLASTIC (43386-530-02) 30 g2014-09-260000-00-00NoNoCurrent
43386-530-054338605300556.7 g in 1 BOTTLE, PLASTIC (43386-530-05) 56.7 g2014-09-260000-00-00NoNoCurrent
43386-530-064338605300660 g in 1 BOTTLE, PLASTIC (43386-530-06) 60 g2014-09-260000-00-00NoNoCurrent