FDA.reportPublic FDA data

nystatin

Product NDC
68788-8690
11-digit product format
687888690
Labeler code
68788
Product ID
68788-8690_77d6819e-b284-42b7-af0b-ccf75793d70a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA062474
Marketing category
ANDA
Marketing start
2024-06-07
Substance
NYSTATIN
Active strength
500000 [USP'U]/1
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
A062474-001NYSTATINNYSTATIN500,000 UNITSTABLET / ORALAA1983-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062474-001AA

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 22:54:322026-06A062474-001NYSTATIN500,000 UNITSTABLET / ORALAA1983-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062474-001AA1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINChartwell RX, LLC30175930-f5fa-403d-a3ac-3bdbbe7236412025-12-17Adverse reactionsExact identifier
application applno (ANDA): 062474
application number: ANDA062474
nystatinNYSTATINPreferred Pharmaceuticals Inc.197e3046-3e58-4246-b260-f3995dce41a12025-08-29Adverse reactionsExact identifier
application applno (ANDA): 062474
application number: ANDA062474
ndc (product): 68788-8690
nystatinNYSTATINBryant Ranch Prepacka5711dbe-f71c-435c-91f2-38c357532d182025-08-19Adverse reactionsExact identifier
application applno (ANDA): 062474
application number: ANDA062474
nystatinNYSTATINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.e87b8480-987d-4f82-87bf-cf831d6984a12025-06-23Adverse reactionsExact identifier
application applno (ANDA): 062474
application number: ANDA062474
nystatinNYSTATINProficient Rx LP04d795f3-aad7-4b79-8ebc-43c500afe39b2021-08-01Adverse reactionsExact identifier
application applno (ANDA): 062474
application number: ANDA062474

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN500000 [USP'U]/1

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
312059Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
197e3046-3e58-4246-b260-f3995dce41a1Available 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
68788-8690-1nystatin120 in 1 BOTTLETABLET, COATED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8690-1EA - Each68788-86909a8497a5-5cd9-4060-8aa0-f344ab21562d12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8690NYSTATIN TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240616_197e3046-3e58-4246-b260-f3995dce41a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSN197e3046-3e58-4246-b260-f3995dce41a12
312059nystatin 500000 UNT Oral TabletSCD197e3046-3e58-4246-b260-f3995dce41a12
312059nystatin 500,000 UNT Oral TabletSY197e3046-3e58-4246-b260-f3995dce41a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8690-168788869001120 TABLET, COATED in 1 BOTTLE (68788-8690-1) 2024-06-07NoNoCurrent