FDA.reportPublic FDA data

Nystatin

Product NDC
0713-0686
11-digit product format
007130686
Labeler code
0713
Product ID
0713-0686_0b479d47-d58c-1457-e063-6394a90a1256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA209114
Marketing category
ANDA
Marketing start
2017-10-06
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
A209114-001NYSTATINNYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2017-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209114-001AT

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 22:54:322026-06A209114-001NYSTATIN100,000 UNITS/GMOINTMENT / TOPICALAT2017-10-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209114-001AT1a50c72e98297…

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
NystatinNYSTATIN OINTMENTCosette Pharmaceuticals, Inc.8f87de59-33f2-32af-ae17-78bf30fb424d2023-11-29Adverse reactionsExact identifier
application applno (ANDA): 209114
application number: ANDA209114
ndc (product): 0713-0686
NystatinNYSTATIN OINTMENTProficient Rx LP711950c4-1889-4acd-ab76-9a16176ce1e42020-03-01Adverse reactionsExact identifier
application applno (ANDA): 209114
application number: ANDA209114

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
8f87de59-33f2-32af-ae17-78bf30fb424dAvailable 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
0713-0686-15Nystatin1 in 1 CARTONOINTMENT19
0713-0686-15Nystatin15 g in 1 TUBEOINTMENT159
0713-0686-31Nystatin30 g in 1 TUBEOINTMENT309
0713-0686-31Nystatin1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0686-15GM - Gram0713-06867ee7a313-49ed-4d46-8aba-2919385d623a12018-12-13
0713-0686-31GM - Gram0713-06869f558f27-0803-4dad-94a4-316b3faee4f912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0686NYSTATIN (NYSTATIN OINTMENT) OINTMENT [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20231130_8f87de59-33f2-32af-ae17-78bf30fb424d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100 UNT/MG Topical OintmentSCD8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100,000 UNT/GM Topical OintmentSY8f87de59-33f2-32af-ae17-78bf30fb424d9
884308nystatin 100,000 UNT/GM Topical OintmentPSN711950c4-1889-4acd-ab76-9a16176ce1e41
884308nystatin 100 UNT/MG Topical OintmentSCD711950c4-1889-4acd-ab76-9a16176ce1e41
884308nystatin 100,000 UNT/GM Topical OintmentSY711950c4-1889-4acd-ab76-9a16176ce1e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0686-15007130686151 TUBE in 1 CARTON (0713-0686-15) / 15 g in 1 TUBE1 tube2018-07-300000-00-00NoNoCurrent
0713-0686-31007130686311 TUBE in 1 CARTON (0713-0686-31) / 30 g in 1 TUBE1 tube2018-07-300000-00-00NoNoCurrent