FDA.reportPublic FDA data

Nystatin and triamcinolone acetonide

Product NDC
33342-482
11-digit product format
333420482
Labeler code
33342
Product ID
33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA214181
Marketing category
ANDA
Marketing start
2022-08-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin and triamcinolone acetonide
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E, F446C597KA
Rxcui1053753

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-482-15Nystatin and triamcinolone acetonide1 in 1 CARTONCREAM12
33342-482-15Nystatin and triamcinolone acetonide15 g in 1 TUBECREAM152
33342-482-30Nystatin and triamcinolone acetonide1 in 1 CARTONCREAM12
33342-482-30Nystatin and triamcinolone acetonide30 g in 1 TUBECREAM302
33342-482-60Nystatin and triamcinolone acetonide60 g in 1 TUBECREAM602
33342-482-60Nystatin and triamcinolone acetonide1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-482-15GM - Gram33342-4825fa4e050-d56c-4586-937c-5e78f9e1df2012024-05-16
33342-482-30GM - Gram33342-48251eb3326-f846-4d9d-b6f8-8caf9893ec2f12024-05-16
33342-482-60GM - Gram33342-48214fbf854-2b97-4b6c-b7e4-c2c5c3e0cd1c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-482NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 6 package rows20230912_57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb2
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNc529567b-7061-4389-8c7a-20ef2b22c5912
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb2
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDc529567b-7061-4389-8c7a-20ef2b22c5912
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY57c4ebe8-7a8d-4fc0-b6cf-a276b68327fb2
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYc529567b-7061-4389-8c7a-20ef2b22c5912
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN4c122a83-a66a-15d6-e063-6294a90acfaa1
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD4c122a83-a66a-15d6-e063-6294a90acfaa1
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY4c122a83-a66a-15d6-e063-6294a90acfaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-482-15333420482151 TUBE in 1 CARTON (33342-482-15) / 15 g in 1 TUBE1 tube2022-08-310000-00-00NoNoCurrent
33342-482-30333420482301 TUBE in 1 CARTON (33342-482-30) / 30 g in 1 TUBE1 tube2022-08-310000-00-00NoNoCurrent
33342-482-60333420482601 TUBE in 1 CARTON (33342-482-60) / 60 g in 1 TUBE1 tube2022-08-310000-00-00NoNoCurrent