FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
21922-062
11-digit product format
219220062
Labeler code
21922
Product ID
21922-062_7b796fae-0c7d-4fb6-9141-f4b52db5c85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA208848
Marketing category
ANDA
Marketing start
2024-03-16
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRIAMCINOLONE ACETONIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-062-04TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM153
21922-062-04TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-05TRIAMCINOLONE ACETONIDE30 g in 1 TUBECREAM303
21922-062-05TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-15TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM13
21922-062-15TRIAMCINOLONE ACETONIDE80 g in 1 TUBECREAM803
21922-062-30TRIAMCINOLONE ACETONIDE454 g in 1 JARCREAM4543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-062-04GM - Gram21922-0620ba7910c-f05a-451e-8d51-0809eb99222e12024-04-05
21922-062-05GM - Gram21922-062ea581114-855e-4609-b594-16581ea1feb912024-04-05
21922-062-15GM - Gram21922-06241f5e86d-e3e0-44e8-aafb-0f403dbab76912024-04-05
21922-062-30GM - Gram21922-062b2e87f67-184d-4e38-a893-f60e1193159812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-062TRIAMCINOLONE ACETONIDE CREAM [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 7 package rows20240320_db87426f-124c-4ea9-bb15-fc3a0da10a4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSNdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 0.1 % Topical CreamSYdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYdb87426f-124c-4ea9-bb15-fc3a0da10a4e3
1014314triamcinolone acetonide 0.1 % Topical CreamPSN60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 0.1 % Topical CreamSY60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY60973042-077c-4265-988c-ad381f5603332
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 0.1 % Topical CreamPSN200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 0.1 % Topical CreamPSNabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 0.1 % Topical CreamPSNc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 0.1 % Topical CreamSYabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 0.1 % Topical CreamSYc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 0.1 % Topical CreamSY200bb913-a6ac-5a6b-e063-6294a90a161a1
1014314triamcinolone acetonide 0.1 % Topical CreamSY4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYc6e46d6f-c64d-4242-a56f-8aff96e689931
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYabad7215-95d2-4171-95cf-fa768081fd3b1
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4e400049-c763-56f7-e063-6294a90a6fd71
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY200bb913-a6ac-5a6b-e063-6294a90a161a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-062-04219220062041 TUBE in 1 CARTON (21922-062-04) / 15 g in 1 TUBE1 tube2024-03-16NoNoCurrent
21922-062-05219220062051 TUBE in 1 CARTON (21922-062-05) / 30 g in 1 TUBE1 tube2024-03-16NoNoCurrent
21922-062-15219220062151 TUBE in 1 CARTON (21922-062-15) / 80 g in 1 TUBE1 tube2024-03-16NoNoCurrent
21922-062-3021922006230454 g in 1 JAR (21922-062-30) 454 g2024-03-16NoNoCurrent