FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
81298-5781
11-digit product format
812985781
Labeler code
81298
Product ID
81298-5781_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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213543-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2022-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213543-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213543-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2022-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213543-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDELong Grove Pharmaceuticals, LLC9e48eec7-7cd5-4174-8b3f-07c96f4ef1152025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213543
application number: ANDA213543
ndc (product): 81298-5781
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProPharma Distribution3edd3ad8-2561-59b5-e063-6294a90a01652025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213543
application number: ANDA213543

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1085754Internal RxNorm lookup
1792144Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e48eec7-7cd5-4174-8b3f-07c96f4ef115Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81298-5781-52023-08-24C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5781-52023-08-24C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5781-52023-07-28C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP
81298-5781-52023-07-28C16284748780-10191ceaa-6824-198a-e063-dbdaa90aec3eTRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81298-5781-1Triamcinolone Acetonide1 mL in 1 VIAL, SINGLE-USESUSPENSION16
81298-5781-5Triamcinolone Acetonide25 in 1 CARTONSUSPENSION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-5781-1ML - Milliliter81298-5781cec99f0e-01e9-4eff-b0a3-8c05bb9d7e6212023-08-08
81298-5781-5ML - Milliliter81298-57811f9c65fe-2fc1-4fea-a7af-76f9ef3fce6812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-5781TRIAMCINOLONE 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
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN3edd3ad8-2561-59b5-e063-6294a90a01651
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD3edd3ad8-2561-59b5-e063-6294a90a01651
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY3edd3ad8-2561-59b5-e063-6294a90a01651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81298-5781-1812985781011 mL in 1 VIAL, SINGLE-USE1 mlHistorical
81298-5781-58129857810525 VIAL, SINGLE-USE in 1 CARTON (81298-5781-5) / 1 mL in 1 VIAL, SINGLE-USE (81298-5781-1) 2022-05-020000-00-00NoNoCurrent