FDA.reportPublic FDA data

Nystatin and Triamcinolone Acetonide

Product NDC
0316-0223
11-digit product format
003160223
Labeler code
0316
Product ID
0316-0223_483437cb-feeb-0aa8-e063-6294a90a5c4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Crown Laboratories
Application
ANDA207730
Marketing category
ANDA
Marketing start
2018-01-02
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000; 1 [USP'U]/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A207730-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207730-001AT

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 22:54:322026-06A207730-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-12-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207730-001AT1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDECrown Laboratories54aae5d3-e482-4da0-a1b2-0ed70e6c29152026-01-12Adverse reactionsExact identifier
application applno (ANDA): 207730
application number: ANDA207730
ndc (product): 0316-0223

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin and Triamcinolone Acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54aae5d3-e482-4da0-a1b2-0ed70e6c2915Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0223-152023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-152023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-152023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-02-13C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-152023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-152023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-152023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-302023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP
0316-0223-602023-01-30C16284748780-1f386c64a-1de1-0266-e053-dadaa90a7c1aNystatin and Triamcinolone Acetonide Cream USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0223-15Nystatin and Triamcinolone Acetonide15 g in 1 TUBECREAM1510
0316-0223-15Nystatin and Triamcinolone Acetonide1 in 1 CARTONCREAM110
0316-0223-30Nystatin and Triamcinolone Acetonide30 g in 1 TUBECREAM3010
0316-0223-30Nystatin and Triamcinolone Acetonide1 in 1 CARTONCREAM110
0316-0223-60Nystatin and Triamcinolone Acetonide60 g in 1 TUBECREAM6010
0316-0223-60Nystatin and Triamcinolone Acetonide1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0223-15GM - Gram0316-022366575de7-e660-4955-873c-78d75ea24f7d12018-04-19
0316-0223-30GM - Gram0316-0223fa88efff-19c3-4f1f-ab56-7b920433a85a12018-04-19
0316-0223-60GM - Gram0316-0223bf4cc766-cbcb-4fd5-a5e0-a0c795b7b3d212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0223NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [CROWN LABORATORIES]8Current NDC, Legacy NDC, 6 package rows20231025_54aae5d3-e482-4da0-a1b2-0ed70e6c2915.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN54aae5d3-e482-4da0-a1b2-0ed70e6c291510
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD54aae5d3-e482-4da0-a1b2-0ed70e6c291510
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY54aae5d3-e482-4da0-a1b2-0ed70e6c291510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0223-15003160223151 TUBE in 1 CARTON (0316-0223-15) / 15 g in 1 TUBE1 tube2018-01-020000-00-00NoNoCurrent
0316-0223-30003160223301 TUBE in 1 CARTON (0316-0223-30) / 30 g in 1 TUBE1 tube2018-01-020000-00-00NoNoCurrent
0316-0223-60003160223601 TUBE in 1 CARTON (0316-0223-60) / 60 g in 1 TUBE1 tube2018-01-020000-00-00NoNoCurrent