FDA.reportPublic FDA data

Nystatin

Product NDC
63187-703
11-digit product format
631870703
Labeler code
63187
Product ID
63187-703_bbcffae3-b609-478f-9702-6ae78847cdba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA064022
Marketing category
ANDA
Marketing start
1993-01-28
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
A064022-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064022-001AT

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 22:54:322026-06A064022-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATRS1993-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064022-001AT1a50c72e98297…

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
NystatinNYSTATINSun Pharmaceutical Industries, Inc.4d845b3f-ca26-4c47-b424-b6d783cc10e52025-07-03Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINNuCare Pharmaceuticals,Inc.cf6b7c68-7769-1808-e053-2995a90aa4262025-02-10Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
NystatinNYSTATINProficient Rx LP5ef15e1c-66dc-4858-8552-d83e42c3883e2019-11-01Adverse reactionsExact identifier
application applno (ANDA): 064022
application number: ANDA064022
ndc (product): 63187-703

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
5ef15e1c-66dc-4858-8552-d83e42c3883eAvailable 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
63187-703-15Nystatin15 g in 1 TUBECREAM153
63187-703-15Nystatin1 in 1 CARTONCREAM13
63187-703-30Nystatin30 g in 1 TUBECREAM303
63187-703-30Nystatin1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-703NYSTATIN CREAM [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191121_5ef15e1c-66dc-4858-8552-d83e42c3883e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN5ef15e1c-66dc-4858-8552-d83e42c3883e3
543546nystatin 100000 UNT/ML Topical CreamSCD5ef15e1c-66dc-4858-8552-d83e42c3883e3
543546nystatin 100,000 UNT/GM Topical CreamSY5ef15e1c-66dc-4858-8552-d83e42c3883e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-703-15631870703151 TUBE in 1 CARTON (63187-703-15) / 15 g in 1 TUBE1 tube2016-06-010000-00-00NoNoCurrent
63187-703-30631870703301 TUBE in 1 CARTON (63187-703-30) / 30 g in 1 TUBE1 tube2016-06-010000-00-00NoNoCurrent