Nystatin and Triamcinolone Acetonide

Product NDC
52565-042
11-digit product format
525650042
Labeler code
52565
Product ID
52565-042_1090fb75-b1de-4939-8695-2870797e40bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208287
Marketing category
ANDA
Marketing start
2016-12-30
Marketing end
0000-00-00
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000 [USP'U]/g; mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-042-15Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT12
52565-042-15Nystatin and Triamcinolone Acetonide15 g in 1 TUBEOINTMENT152
52565-042-30Nystatin and Triamcinolone Acetonide30 g in 1 TUBEOINTMENT302
52565-042-30Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT12
52565-042-60Nystatin and Triamcinolone Acetonide60 g in 1 TUBEOINTMENT602
52565-042-60Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-042-15GM - Gram52565-0422853beb7-0a69-4f23-af54-2691470c9cd312017-03-06
52565-042-30GM - Gram52565-0423980074b-de5f-4428-9d4b-75e93e9cda2e12017-03-06
52565-042-60GM - Gram52565-042a30354d2-6827-4029-b253-6222ef335b6e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-042NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 6 package rows20190911_373276df-6a72-44cb-82a2-4098a16d86c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSN373276df-6a72-44cb-82a2-4098a16d86c72
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD373276df-6a72-44cb-82a2-4098a16d86c72
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSY373276df-6a72-44cb-82a2-4098a16d86c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-042-15525650042151 TUBE in 1 CARTON (52565-042-15) > 15 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent
52565-042-30525650042301 TUBE in 1 CARTON (52565-042-30) > 30 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent
52565-042-60525650042601 TUBE in 1 CARTON (52565-042-60) > 60 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent