FDA.reportPublic FDA data

NYSTATIN

Product NDC
59651-907
11-digit product format
596510907
Labeler code
59651
Product ID
59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219527
Marketing category
ANDA
Marketing start
2025-03-21
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 42.

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
A219527-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219527-001AT

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
2026-08-18 06:07:402026-07A219527-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219527-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219527-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219527-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219527-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2025-03-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219527-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219527-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219527-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219527-001AT16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219527-001AT1a50c72e98297…

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
543546Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d8a30ab-465e-4804-a06b-afd689e16683Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-907-14NYSTATIN1 in 1 CARTONCREAM12
59651-907-14NYSTATIN15 g in 1 TUBECREAM152
59651-907-30NYSTATIN30 g in 1 TUBECREAM302
59651-907-30NYSTATIN1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-907-14GM - Gram59651-907bf17e99f-b70a-460a-897d-98bbb549102612026-01-08
59651-907-30GM - Gram59651-9079578b7ad-eb7f-4667-b5c6-95f0216884b612026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-907NYSTATIN CREAM [AUROBINDO PHARMA LIMITED]1Current NDC, 4 package rows20250403_7d8a30ab-465e-4804-a06b-afd689e16683.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATINNYSTATINAurobindo Pharma Limited7d8a30ab-465e-4804-a06b-afd689e166832025-06-18Adverse reactionsExact identifier
application applno (ANDA): 219527
application number: ANDA219527
ndc (product): 59651-907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN7d8a30ab-465e-4804-a06b-afd689e166832
543546nystatin 100000 UNT/ML Topical CreamSCD7d8a30ab-465e-4804-a06b-afd689e166832
543546nystatin 100,000 UNT/GM Topical CreamSY7d8a30ab-465e-4804-a06b-afd689e166832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-907-14596510907141 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE1 tube2025-03-21NoNoCurrent
59651-907-30596510907301 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE1 tube2025-03-21NoNoCurrent