FDA.reportPublic FDA data

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product NDC
45802-880
11-digit product format
458020880
Labeler code
45802
Product ID
45802-880_3f4fba52-76cc-4ac5-aee1-e562d5c37a64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin, triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA208479
Marketing category
ANDA
Marketing start
2017-11-27
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-880-14NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM16
45802-880-14NYSTATIN AND TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM156
45802-880-94NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM16
45802-880-94NYSTATIN AND TRIAMCINOLONE ACETONIDE30 g in 1 TUBECREAM306
45802-880-96NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM16
45802-880-96NYSTATIN AND TRIAMCINOLONE ACETONIDE60 g in 1 TUBECREAM606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-880-14GM - Gram45802-8807176496a-63ac-4c3d-b81a-fe0f1098126312017-12-14
45802-880-94GM - Gram45802-8808c2d6593-395f-43cd-a8ff-be7fd8fd47c112017-12-14
45802-880-96GM - Gram45802-8806abba9df-b204-4730-8a8e-d2eac07b820c12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-880NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN, TRIAMCINOLONE ACETONIDE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 6 package rows20230831_92fc188d-4f3e-4d18-aaf1-c9e76b12b75b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN92b08b14-a933-454b-8b6f-4b5e7c682953110
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD92b08b14-a933-454b-8b6f-4b5e7c682953110
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY92b08b14-a933-454b-8b6f-4b5e7c682953110
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNb3056a63-d149-4ed4-84bc-918f5ff94a62109
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN6f25f129-a682-47d0-8788-bac21b65c830109
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD6f25f129-a682-47d0-8788-bac21b65c830109
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDb3056a63-d149-4ed4-84bc-918f5ff94a62109
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY6f25f129-a682-47d0-8788-bac21b65c830109
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYb3056a63-d149-4ed4-84bc-918f5ff94a62109
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNc82fc464-d021-4a7c-8141-46d3d80134a2102
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDc82fc464-d021-4a7c-8141-46d3d80134a2102
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYc82fc464-d021-4a7c-8141-46d3d80134a2102
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNf81f461b-54cd-45bf-bf96-da77a5edc1e6100
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDf81f461b-54cd-45bf-bf96-da77a5edc1e6100
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYf81f461b-54cd-45bf-bf96-da77a5edc1e6100
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN92fc188d-4f3e-4d18-aaf1-c9e76b12b75b6
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD92fc188d-4f3e-4d18-aaf1-c9e76b12b75b6
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY92fc188d-4f3e-4d18-aaf1-c9e76b12b75b6
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNc8beaa42-eb3a-d160-e053-2a95a90a31082
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDc8beaa42-eb3a-d160-e053-2a95a90a31082
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYc8beaa42-eb3a-d160-e053-2a95a90a31082
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN1ecdab7b-8b54-128e-e063-6394a90a8a231
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN11d5d905-70c1-4c12-b992-fe4c3b8c2fca1
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD11d5d905-70c1-4c12-b992-fe4c3b8c2fca1
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD1ecdab7b-8b54-128e-e063-6394a90a8a231
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY1ecdab7b-8b54-128e-e063-6394a90a8a231
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY11d5d905-70c1-4c12-b992-fe4c3b8c2fca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-880-14458020880141 TUBE in 1 CARTON (45802-880-14) / 15 g in 1 TUBE1 tube2017-11-270000-00-00NoNoCurrent
45802-880-94458020880941 TUBE in 1 CARTON (45802-880-94) / 30 g in 1 TUBE1 tube2017-11-270000-00-00NoNoCurrent
45802-880-96458020880961 TUBE in 1 CARTON (45802-880-96) / 60 g in 1 TUBE1 tube2017-11-270000-00-00NoNoCurrent