FDA.reportPublic FDA data

NYSTATIN

Product NDC
63629-2493
11-digit product format
636292493
Labeler code
63629
Product ID
63629-2493_4d605e1a-4670-4080-bc99-7c91a1f5bcd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062832
Marketing category
ANDA
Marketing start
2020-08-14
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-2493DDiscontinued by firm2026-07-31
excluded packagepackage63629-249363629-2493-1DDiscontinued 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
A062832-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062832-001AA

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 22:54:322026-06A062832-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1991-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062832-001AA1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINKesin Pharma Corporation50737729-a4a4-e747-e063-6394a90adcc52026-06-30Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepack4f6f59fb-ae7d-48e5-b23e-a1d92160974f2026-05-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKesin Pharma Corporation43817169-bbe8-58ee-e063-6294a90a12502025-12-11Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINKanchan Healthcare Inc90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a2025-09-12Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832
NYSTATINNYSTATINBryant Ranch Prepackb06c65cd-5b65-4bc6-aae9-b9381c6f19482023-01-26Adverse reactionsExact identifier
application applno (ANDA): 062832
application number: ANDA062832

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2493-1ML - Milliliter63629-24936dc991b0-f3cf-4e32-9d24-234d6533018f12021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2493-1636292493011 BOTTLE, DROPPER in 1 CARTON (63629-2493-1) > 60 mL in 1 BOTTLE, DROPPER2021-03-030000-00-00NoNoCurrent