FDA.reportPublic FDA data

Nystatin

Product NDC
0472-0163
11-digit product format
004720163
Labeler code
0472
Product ID
0472-0163_e358ed42-af82-4c96-b78d-c3a8a84fed51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA062949
Marketing category
ANDA
Marketing start
2010-07-21
Marketing end
2021-01-30
Substance
NYSTATIN
Active strength
100000 [USP'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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0472-0163DDiscontinued by firm2026-07-31
excluded packagepackage0472-01630472-0163-15DDiscontinued by firm2026-07-31
excluded packagepackage0472-01630472-0163-30DDiscontinued 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
A062949-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALAT1988-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062949-001AT

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 22:54:322026-06A062949-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT1988-06-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062949-001AT1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0163-15GM - Gram0472-0163b87845c2-79fd-45a4-a767-33714f3e7b7412013-02-13
0472-0163-30GM - Gram0472-0163eed2ca4f-24d7-4c54-a17f-23fb36cc444b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [ACTAVIS MID ATLANTIC LLC]4
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNYSTATIN CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PROFICIENT RX LP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN CREAM [PROFICIENT RX LP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PROFICIENT RX LP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PROFICIENT RX LP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN6cf3daed-075e-4cb8-84fc-00a376fb549f2
543546nystatin 100000 UNT/ML Topical CreamSCD6cf3daed-075e-4cb8-84fc-00a376fb549f2
543546nystatin 100,000 UNT/GM Topical CreamSY6cf3daed-075e-4cb8-84fc-00a376fb549f2