FDA.reportPublic FDA data

Nystatin

Product NDC
0472-0166
11-digit product format
004720166
Labeler code
0472
Product ID
0472-0166_6a5c1ca5-b727-4129-b884-fa7d3eb2cd8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA062840
Marketing category
ANDA
Marketing start
2002-09-03
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A062840-001NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT1987-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062840-001AT

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 22:54:322026-06A062840-001NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT1987-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062840-001AT1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINActavis Pharma, Inc.aee7ce4c-8cc6-4446-a4d7-63bc4773066f2023-10-30Adverse reactionsExact identifier
application applno (ANDA): 062840
application number: ANDA062840
ndc (product): 0472-0166
NystatinNYSTATINProficient Rx LPd7d04c02-d07d-4382-8f93-5c0c3e68790c2022-10-01Adverse reactionsExact identifier
application applno (ANDA): 062840
application number: ANDA062840

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884308Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aee7ce4c-8cc6-4446-a4d7-63bc4773066fAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0472-0166-152024-02-06C16284748780-11030e365-02d3-111a-e063-dadaa90a10e2NYSTATIN OINTMENT, USP (100,000 units/g)
0472-0166-302024-02-06C16284748780-11030e365-02d3-111a-e063-dadaa90a10e2NYSTATIN OINTMENT, USP (100,000 units/g)
0472-0166-152024-01-30C16284748780-11030e365-02d3-111a-e063-dadaa90a10e2NYSTATIN OINTMENT, USP (100,000 units/g)
0472-0166-302024-01-30C16284748780-11030e365-02d3-111a-e063-dadaa90a10e2NYSTATIN OINTMENT, USP (100,000 units/g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0166-15Nystatin15 g in 1 TUBEOINTMENT158
0472-0166-15Nystatin1 in 1 CARTONOINTMENT18
0472-0166-30Nystatin30 g in 1 TUBEOINTMENT308
0472-0166-30Nystatin1 in 1 CARTONOINTMENT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0166-15GM - Gram0472-0166425f994d-fab4-43bd-885c-5c95b3fc668e12012-07-24
0472-0166-30GM - Gram0472-0166ce406d70-fd20-477a-82fe-957542c0628012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [ACTAVIS MID ATLANTIC LLC]2
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [ACTAVIS MID ATLANTIC LLC]2
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [PROFICIENT RX LP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0166NYSTATIN OINTMENT [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 4 package rows20240207_aee7ce4c-8cc6-4446-a4d7-63bc4773066f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSNaee7ce4c-8cc6-4446-a4d7-63bc4773066f8
884308nystatin 100 UNT/MG Topical OintmentSCDaee7ce4c-8cc6-4446-a4d7-63bc4773066f8
884308nystatin 100,000 UNT/GM Topical OintmentSYaee7ce4c-8cc6-4446-a4d7-63bc4773066f8
884308nystatin 100,000 UNT/GM Topical OintmentPSNd7d04c02-d07d-4382-8f93-5c0c3e68790c5
884308nystatin 100 UNT/MG Topical OintmentSCDd7d04c02-d07d-4382-8f93-5c0c3e68790c5
884308nystatin 100,000 UNT/GM Topical OintmentSYd7d04c02-d07d-4382-8f93-5c0c3e68790c5
884308nystatin 100,000 UNT/GM Topical OintmentPSNaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1
884308nystatin 100 UNT/MG Topical OintmentSCDaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1
884308nystatin 100,000 UNT/GM Topical OintmentSYaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0166-15004720166151 TUBE in 1 CARTON (0472-0166-15) / 15 g in 1 TUBE1 tube2002-09-030000-00-00NoNoCurrent
0472-0166-30004720166301 TUBE in 1 CARTON (0472-0166-30) / 30 g in 1 TUBE1 tube2002-09-030000-00-00NoNoCurrent