FDA.reportPublic FDA data

Nystatin

Product NDC
0168-0007
11-digit product format
001680007
Labeler code
0168
Product ID
0168-0007_2563e491-2277-4393-8632-8127fb983e1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA062124
Marketing category
ANDA
Marketing start
1982-09-23
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0168-0007DDiscontinued by firm2026-07-31
excluded packagepackage0168-00070168-0007-15DDiscontinued by firm2026-07-31
excluded packagepackage0168-00070168-0007-30DDiscontinued by firm2026-07-31

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
A062124-002NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALATRS1982-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062124-002AT

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 22:54:322026-06A062124-002NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALATRS1982-09-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062124-002AT1a50c72e98297…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0007-15GM - Gram0168-000752751ca1-1910-4597-8fa6-faa22e9bacab12012-07-24
0168-0007-30GM - Gram0168-0007e865dc45-e1a9-4f36-b7cc-2aa04b9958ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NYSTATIN OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
Mineral OilINACTIVE INGREDIENTT5L8T28FGPNYSTATIN OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
Mineral OilINACTIVE INGREDIENTT5L8T28FGPNYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]3
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP]1
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPNYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSNdb8e62a1-9a5e-49d1-8c6b-64a3e083487c3
884308nystatin 100 UNT/MG Topical OintmentSCDdb8e62a1-9a5e-49d1-8c6b-64a3e083487c3
884308nystatin 100,000 UNT/GM Topical OintmentSYdb8e62a1-9a5e-49d1-8c6b-64a3e083487c3
884308nystatin 100,000 UNT/GM Topical OintmentPSNda4cd3fc-906d-4468-b7f9-c20f085c95ed1
884308nystatin 100 UNT/MG Topical OintmentSCDda4cd3fc-906d-4468-b7f9-c20f085c95ed1
884308nystatin 100,000 UNT/GM Topical OintmentSYda4cd3fc-906d-4468-b7f9-c20f085c95ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0007-150016800071515 g in 1 TUBE (0168-0007-15) 15 g1982-09-230000-00-00NoNoCurrent
0168-0007-300016800073030 g in 1 TUBE (0168-0007-30) 30 g1982-09-230000-00-00NoNoCurrent