FDA.reportPublic FDA data

nystatin

Product NDC
0168-0037
11-digit product format
001680037
Labeler code
0168
Product ID
0168-0037_cbc1646c-2fe3-4140-a73c-aaee7c9013c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA062517
Marketing category
ANDA
Marketing start
1984-06-07
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0168-0037DDiscontinued by firm2026-07-31
excluded packagepackage0168-00370168-0037-60DDiscontinued 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
A062517-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062517-001AA

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 22:54:322026-06A062517-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-06-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062517-001AA1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0037-602024-07-12C16284748780-19d75b9cf-e855-f424-e053-dadaa90a57ceNystatin Oral Suspension, USP
0168-0037-602020-01-31C16284748780-19d75b9cf-e855-f424-e053-dadaa90a57ceNystatin Oral Suspension, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74NYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]2