FDA.reportPublic FDA data

Nystatin

Product NDC
68788-8631
11-digit product format
687888631
Labeler code
68788
Product ID
68788-8631_efb3a87c-639a-4cd2-905a-73e79bd7778b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212557
Marketing category
ANDA
Marketing start
2024-04-15
Substance
NYSTATIN
Active strength
100000 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
A212557-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212557-001AT

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 22:54:322026-06A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212557-001AT1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINBryant Ranch Prepack2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc2026-07-09Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINTorrent Pharmaceuticals Limited559b5bd4-3564-4437-8d0a-fa3a972f8b832026-05-01Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINRedPharm Drug, Incf4c298d5-b012-7b56-e053-2a95a90a3d552026-01-24Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINPreferred Pharmaceuticals Inc.d92f67a7-dcae-41c0-9a35-dbafa23611702025-08-28Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
ndc (product): 68788-8631
NystatinNYSTATINA-S Medication Solutions65167baa-29f8-44d3-b2d2-935c862d463e2024-10-16Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINProficient Rx LP8566c432-741f-4af7-91d7-1b7668ce5e952023-12-01Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 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
d92f67a7-dcae-41c0-9a35-dbafa2361170Available 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
68788-8631-1Nystatin15 g in 1 TUBECREAM152
68788-8631-3Nystatin30 g in 1 TUBECREAM302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8631-1GM - Gram68788-863188c7c17b-4884-4ea9-a44d-47063d058f6412024-07-12
68788-8631-3GM - Gram68788-86319662e03d-accb-494e-994e-f272c4dd951112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8631NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240420_d92f67a7-dcae-41c0-9a35-dbafa2361170.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNd92f67a7-dcae-41c0-9a35-dbafa23611702
543546nystatin 100000 UNT/ML Topical CreamSCDd92f67a7-dcae-41c0-9a35-dbafa23611702
543546nystatin 100,000 UNT/GM Topical CreamSYd92f67a7-dcae-41c0-9a35-dbafa23611702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8631-16878886310115 g in 1 TUBE (68788-8631-1) 15 g2024-04-15NoNoCurrent
68788-8631-36878886310330 g in 1 TUBE (68788-8631-3) 30 g2024-04-15NoNoCurrent