FDA.reportPublic FDA data

Nystatin

Product NDC
16714-769
11-digit product format
167140769
Labeler code
16714
Product ID
16714-769_44c4d03f-5cab-47e6-ba45-0bfb6062a400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
NorthStar Rx LLC
Application
ANDA065203
Marketing category
ANDA
Marketing start
2018-05-21
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-769DDiscontinued by firm2026-08-03
excluded packagepackage16714-76916714-769-01DDiscontinued by firm2026-08-03
excluded packagepackage16714-76916714-769-02DDiscontinued by firm2026-08-03
excluded packagepackage16714-76916714-769-03DDiscontinued by firm2026-08-03

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
A065203-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALATRS2004-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065203-001AT

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 22:54:322026-06A065203-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALATRS2004-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065203-001AT1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINDr. Reddy's Labratories Inc.6bde84a1-341d-09ce-58b6-f9a653dc98c52024-04-12Adverse reactionsExact identifier
application applno (ANDA): 065203
application number: ANDA065203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-769-01GM - Gram16714-7699375accb-58c3-4ed5-b29a-c3fe335d98d312018-09-05
16714-769-02GM - Gram16714-7699f230df7-435f-4c5d-8a62-48068763754612018-09-05
16714-769-03GM - Gram16714-769c2f56d0e-cd9b-47d9-a462-bb3f4b8ae71c12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-769-011671407690115 g in 1 BOTTLE, PLASTIC (16714-769-01) 15 g2018-05-210000-00-00NoNoCurrent
16714-769-021671407690230 g in 1 BOTTLE, PLASTIC (16714-769-02) 30 g2018-05-210000-00-00NoNoCurrent
16714-769-031671407690360 g in 1 BOTTLE, PLASTIC (16714-769-03) 60 g2018-05-210000-00-00NoNoCurrent