FDA.reportPublic FDA data

Nyamyc

Product NDC
0832-0465
11-digit product format
008320465
Labeler code
0832
Product ID
0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA065183
Marketing category
ANDA
Marketing start
2005-05-03
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
A065183-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2005-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065183-001AT

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 22:54:322026-06A065183-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2005-05-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065183-001AT1a50c72e98297…

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
NyamycNYSTATINUpsher-Smith Laboratories, LLC01b44f91-9b68-464a-9693-b5d3e793bf3c2025-07-09Adverse reactionsExact identifier
application applno (ANDA): 065183
application number: ANDA065183
ndc (product): 0832-0465

Additional Listing Data#

Finished product
Yes
Brand name base
Nyamyc
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
584414Internal RxNorm lookup
646456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01b44f91-9b68-464a-9693-b5d3e793bf3cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0465-15Nyamyc1 in 1 CARTONPOWDER112
0832-0465-15Nyamyc15 g in 1 BOTTLE, PLASTICPOWDER1512
0832-0465-30Nyamyc30 g in 1 BOTTLE, PLASTICPOWDER3012
0832-0465-30Nyamyc1 in 1 CARTONPOWDER112
0832-0465-60Nyamyc1 in 1 CARTONPOWDER112
0832-0465-60Nyamyc60 g in 1 BOTTLE, PLASTICPOWDER6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0465-15GM - Gram0832-04657c293bd7-91fb-4e05-9e87-f9c98b2f2d3f12012-07-24
0832-0465-30GM - Gram0832-0465f9db7573-b092-45cb-88c4-11f0e3a2311912012-07-24
0832-0465-60GM - Gram0832-0465ec61df16-4ccd-4237-99ef-6c6d538dc89612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES INC.]4
NYSTATINACTIVE MOIETYBDF1O1C72ENYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UNYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0465NYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES, LLC]11Current NDC, Legacy NDC, 6 package rows20240619_01b44f91-9b68-464a-9693-b5d3e793bf3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
584414Nyamyc 100,000 UNT/GM Topical PowderPSN01b44f91-9b68-464a-9693-b5d3e793bf3c12
646456nystatin 100,000 UNT/GM Topical PowderPSN01b44f91-9b68-464a-9693-b5d3e793bf3c12
584414nystatin 100 UNT/MG Topical Powder [Nyamyc]SBD01b44f91-9b68-464a-9693-b5d3e793bf3c12
646456nystatin 100 UNT/MG Topical PowderSCD01b44f91-9b68-464a-9693-b5d3e793bf3c12
584414Nyamyc 100 UNT/MG Topical PowderSY01b44f91-9b68-464a-9693-b5d3e793bf3c12
584414Nyamyc 100,000 UNT/GM Topical PowderSY01b44f91-9b68-464a-9693-b5d3e793bf3c12
646456nystatin 100,000 UNT/GM Topical PowderSY01b44f91-9b68-464a-9693-b5d3e793bf3c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-0465-15008320465151 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC2005-05-030000-00-00NoNoCurrent
0832-0465-30008320465301 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC2005-05-030000-00-00NoNoCurrent
0832-0465-60008320465601 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC2012-03-090000-00-00NoNoCurrent