FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
81298-5785
11-digit product format
812985785
Labeler code
81298
Product ID
81298-5785_212d73ad-242c-4180-aa94-8b9d12b60318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
SUSPENSION
Route
INTRA-ARTERIAL; INTRAMUSCULAR
Labeler
Long Grove Pharmaceuticals, LLC
Application
ANDA213543
Marketing category
ANDA
Marketing start
2022-05-02
Substance
TRIAMCINOLONE ACETONIDE
Active strength
40 mg/mL
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 ACETONIDE40 mg/mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81298-5785-32023-08-24C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5785-32023-08-24C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5785-32023-07-28C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5785-32023-07-28C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81298-5785-3Triamcinolone Acetonide5 mL in 1 VIAL, MULTI-DOSESUSPENSION56
81298-5785-3Triamcinolone Acetonide1 in 1 CARTONSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-5785-3ML - Milliliter81298-578579d472f0-a23c-436b-9756-fd3b93cfc4d012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-5785TRIAMCINOLONE ACETONIDE SUSPENSION [LONG GROVE PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20240806_9e48eec7-7cd5-4174-8b3f-07c96f4ef115.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN9e48eec7-7cd5-4174-8b3f-07c96f4ef1156
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSN9e48eec7-7cd5-4174-8b3f-07c96f4ef1156
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD9e48eec7-7cd5-4174-8b3f-07c96f4ef1156
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCD9e48eec7-7cd5-4174-8b3f-07c96f4ef1156
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY9e48eec7-7cd5-4174-8b3f-07c96f4ef1156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81298-5785-3812985785031 VIAL, MULTI-DOSE in 1 CARTON (81298-5785-3) / 5 mL in 1 VIAL, MULTI-DOSE2022-05-020000-00-00NoNoCurrent