FDA.reportPublic FDA data

Nystatin

Product NDC
68094-599
11-digit product format
680940599
Labeler code
68094
Product ID
68094-599_c5e09aec-bb6a-4a07-b34d-745c94092f2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA062512
Marketing category
ANDA
Marketing start
2005-12-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
500000 [USP'U]/5mL
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68094-599DDiscontinued by firm2026-07-31
excluded packagepackage68094-59968094-599-58DDiscontinued by firm2026-07-31
excluded packagepackage68094-59968094-599-61DDiscontinued by firm2026-07-31
excluded packagepackage68094-59968094-599-62DDiscontinued 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
A062512-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062512-001AA

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 22:54:322026-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062512-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512
NystatinNYSTATINA-S Medication Solutionse069d495-7f1a-4970-8f4d-aa93d124b3fc2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-599-58ML - Milliliter68094-599fe4c5e77-539a-48b8-9670-2289436110c112012-07-24
68094-599-59ML - Milliliter68094-5993f13beeb-08f4-487c-9f7a-7d85df700b2f12012-07-24
68094-599-61ML - Milliliter68094-599a1fc89af-e887-4bbe-ac2a-e6f648d23dc612012-07-24
68094-599-62ML - Milliliter68094-5991390113c-4118-4d30-b644-756c980b917012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [PRECISION DOSE, INC.]2
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [CARDINAL HEALTH]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [CARDINAL HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-599-616809405996110 TRAY in 1 CASE (68094-599-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-599-59) 10 tray2005-12-150000-00-00NoNoCurrent
68094-599-62680940599623 TRAY in 1 CASE (68094-599-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-599-59) 3 tray2005-12-150000-00-00NoNoCurrent