FDA.reportPublic FDA data

Nystatin

Product NDC
0904-6456
11-digit product format
009046456
Labeler code
0904
Product ID
0904-6456_8c6b5207-d7d1-4e01-b271-35b57bce8ca8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
ANDA065138
Marketing category
ANDA
Marketing start
2015-02-15
Marketing end
2019-04-29
Substance
NYSTATIN
Active strength
100000 U/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0904-6456DDiscontinued by firm2026-07-31
excluded packagepackage0904-64560904-6456-02DDiscontinued by firm2026-07-31
excluded packagepackage0904-64560904-6456-31DDiscontinued by firm2026-07-31
excluded packagepackage0904-64560904-6456-36DDiscontinued 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
A065138-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065138-001AT

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 22:54:322026-06A065138-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2004-07-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065138-001AT1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6456-02GM - Gram0904-6456e0afc34a-24fa-4997-8d95-e096c349d23412015-03-03
0904-6456-31GM - Gram0904-6456590ec48f-f796-414f-9223-166bedc67f0412015-03-03
0904-6456-36GM - Gram0904-64562d08cba7-2156-4934-a53e-b76acf8d718012015-03-03