FDA.reportPublic FDA data

Nystatin and Triamcinolone Acetonide

Product NDC
21922-031
11-digit product format
219220031
Labeler code
21922
Product ID
21922-031_b18e996f-bdb8-4028-9862-fbab75aebf69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
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
21922-031-04Nystatin and Triamcinolone Acetonide15 g in 1 TUBEOINTMENT153
21922-031-04Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT13
21922-031-05Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT13
21922-031-05Nystatin and Triamcinolone Acetonide30 g in 1 TUBEOINTMENT303
21922-031-07Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT13
21922-031-07Nystatin and Triamcinolone Acetonide60 g in 1 TUBEOINTMENT603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-031-04GM - Gram21922-031ae913c2b-f20d-4707-95df-b1af5304e80812019-11-12
21922-031-05GM - Gram21922-03180febd02-fce9-43e9-a532-31e75ac3da2812019-11-12
21922-031-07GM - Gram21922-0314ba38dd5-d397-496e-9aa4-65f53929a3ed12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-031NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]2Current NDC, Legacy NDC, 6 package rows20220115_d33829fc-86df-4e28-82c3-9dbcd8a9e28d.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
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSN3dab5155-9c86-464b-b41b-1507ff49a694108
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSNc62979d3-c9a4-4d94-956e-30760266daf4108
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD3dab5155-9c86-464b-b41b-1507ff49a694108
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDc62979d3-c9a4-4d94-956e-30760266daf4108
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSY3dab5155-9c86-464b-b41b-1507ff49a694108
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSYc62979d3-c9a4-4d94-956e-30760266daf4108
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSNec28a12b-96f8-44ff-a440-8cff34ac2095104
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDec28a12b-96f8-44ff-a440-8cff34ac2095104
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSYec28a12b-96f8-44ff-a440-8cff34ac2095104
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSN26fd7fb6-6eeb-47f1-bbc4-001e84f99625100
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSNd36c64f7-5481-45e4-ac9c-e16ae2194c6e100
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDd36c64f7-5481-45e4-ac9c-e16ae2194c6e100
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD26fd7fb6-6eeb-47f1-bbc4-001e84f99625100
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSYd36c64f7-5481-45e4-ac9c-e16ae2194c6e100
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSY26fd7fb6-6eeb-47f1-bbc4-001e84f99625100
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSNd33829fc-86df-4e28-82c3-9dbcd8a9e28d3
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDd33829fc-86df-4e28-82c3-9dbcd8a9e28d3
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSYd33829fc-86df-4e28-82c3-9dbcd8a9e28d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-031-04219220031041 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBE1 tube2019-09-280000-00-00NoNoCurrent
21922-031-05219220031051 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBE1 tube2019-09-280000-00-00NoNoCurrent
21922-031-07219220031071 TUBE in 1 CARTON (21922-031-07) / 60 g in 1 TUBE1 tube2019-09-280000-00-00NoNoCurrent