FDA.reportPublic FDA data

Nystatin and Triamcinolone Acetonide

Product NDC
63629-2497
11-digit product format
636292497
Labeler code
63629
Product ID
63629-2497_dbe7b437-6b8e-44e5-b7d5-aa3f96c50d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA207741
Marketing category
ANDA
Marketing start
2019-09-28
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
Rxcui1053697

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
63629-2497-1Nystatin and Triamcinolone Acetonide15 g in 1 TUBEOINTMENT151089
63629-2497-1Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT11089

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2497-1GM - Gram63629-249758c4a017-6ec3-4e55-b49b-1a5d8435dbc112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2497NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) OINTMENT [BRYANT RANCH PREPACK]1089Current NDC, Legacy NDC, 2 package rows20240820_f3e21d77-7ca9-4ca9-97f9-b394f7202aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSNf3e21d77-7ca9-4ca9-97f9-b394f7202aa61089
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDf3e21d77-7ca9-4ca9-97f9-b394f7202aa61089
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSYf3e21d77-7ca9-4ca9-97f9-b394f7202aa61089

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2497-1636292497011 TUBE in 1 CARTON (63629-2497-1) / 15 g in 1 TUBE1 tube2019-09-280000-00-00NoNoCurrent