FDA.reportPublic FDA data

Nystatin

Product NDC
71205-723
11-digit product format
712050723
Labeler code
71205
Product ID
71205-723_b1efcc2c-f71a-463d-9a02-fad7550f31ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA061966
Marketing category
ANDA
Marketing start
2015-04-01
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
A061966-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A061966-001AT

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 22:54:322026-06A061966-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A061966-001AT1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINA-S Medication Solutions98bd8ccb-0c68-47b9-bcb4-c5d8217868d92026-07-24Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMNuCare Pharmaceuticals, Inc.42f21220-c68a-d748-e063-6394a90a1e2f2025-11-06Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATINA-S Medication Solutionsa1b5ccb2-d0d6-46cc-b792-6920b50d0a032025-05-15Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMCosette Pharmaceuticals, Inc.ec1b52af-d38e-eba1-e63c-dba4341d3af22022-11-22Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
NystatinNYSTATIN CREAMProficient Rx LPb1efcc2c-f71a-463d-9a02-fad7550f31ec2022-11-01Adverse reactionsExact identifier
application applno (ANDA): 061966
application number: ANDA061966
ndc (product): 71205-723

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
b1efcc2c-f71a-463d-9a02-fad7550f31ecAvailable 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
71205-723-30Nystatin30 g in 1 TUBECREAM301
71205-723-30Nystatin1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-723NYSTATIN (NYSTATIN CREAM) CREAM [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20221124_b1efcc2c-f71a-463d-9a02-fad7550f31ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNb1efcc2c-f71a-463d-9a02-fad7550f31ec1
543546nystatin 100000 UNT/ML Topical CreamSCDb1efcc2c-f71a-463d-9a02-fad7550f31ec1
543546nystatin 100,000 UNT/GM Topical CreamSYb1efcc2c-f71a-463d-9a02-fad7550f31ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-723-30712050723301 TUBE in 1 CARTON (71205-723-30) / 30 g in 1 TUBE1 tube2022-11-170000-00-00NoNoCurrent