FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
67457-623
11-digit product format
674570623
Labeler code
67457
Product ID
67457-623_62c6d537-d5d7-470d-9150-c812aae062ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRAMUSCULAR
Labeler
Mylan Institutional LLC
Application
ANDA212567
Marketing category
ANDA
Marketing start
2023-05-08
Substance
TRIAMCINOLONE ACETONIDE
Active strength
400 mg/10mL
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 ACETONIDE400 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085754, 1792144

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
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
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
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-623-10TRIAMCINOLONE ACETONIDE1 in 1 CARTONINJECTION, SUSPENSION16
67457-623-10TRIAMCINOLONE ACETONIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION106
67457-623-99TRIAMCINOLONE ACETONIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION106
67457-623-99TRIAMCINOLONE ACETONIDE25 in 1 CARTONINJECTION, SUSPENSION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-623-10ML - Milliliter67457-623576efa1b-8709-469e-9748-8fec3be312e612023-06-06
67457-623-99ML - Milliliter67457-62353d545bd-c739-4e40-9e6d-55c7bfb54c0512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-623TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION [MYLAN INSTITUTIONAL LLC]6Current NDC, 4 package rows20250507_4015ad7d-46bf-454e-ac86-91fa5dd6a07b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN4015ad7d-46bf-454e-ac86-91fa5dd6a07b6
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSN4015ad7d-46bf-454e-ac86-91fa5dd6a07b6
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD4015ad7d-46bf-454e-ac86-91fa5dd6a07b6
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCD4015ad7d-46bf-454e-ac86-91fa5dd6a07b6
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY4015ad7d-46bf-454e-ac86-91fa5dd6a07b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67457-623-10674570623101 in 1 CARTONHistorical
67457-623-996745706239925 VIAL, MULTI-DOSE in 1 CARTON (67457-623-99) / 10 mL in 1 VIAL, MULTI-DOSE2024-08-19NoNoCurrent