FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
62332-091
Requested package NDC
62332-091-10
11-digit product format
623320091
Labeler code
62332
Product ID
62332-091_6669782e-f36e-4625-879a-155b8fb814ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRAMUSCULAR
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA218601
Marketing category
ANDA
Marketing start
2025-10-17
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

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
A218601-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218601-001AB

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
2026-02-19 14:30 UTC2026-02A218601-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218601-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218601-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218601-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218601-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218601-001AB1a50c72e98297…

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 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
05c2a9cf-a018-48c0-9c73-2d59d52211d2Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-091-10Triamcinolone Acetonide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION105
62332-091-10Triamcinolone Acetonide1 in 1 CARTONINJECTION, SUSPENSION15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESagent Pharmaceuticals7dbee70b-bd11-4430-b626-97fbb8f01b492026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218601
application number: ANDA218601
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Inc.05c2a9cf-a018-48c0-9c73-2d59d52211d22025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218601
application number: ANDA218601
ndc (package): 62332-091-10
ndc (product): 62332-091
ndc11 (package): 62332009110
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Limitedc0b487dd-a47b-42fd-a855-5d237c5651a92025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218601
application number: ANDA218601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN05c2a9cf-a018-48c0-9c73-2d59d52211d25
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSN05c2a9cf-a018-48c0-9c73-2d59d52211d25
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD05c2a9cf-a018-48c0-9c73-2d59d52211d25
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCD05c2a9cf-a018-48c0-9c73-2d59d52211d25
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY05c2a9cf-a018-48c0-9c73-2d59d52211d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-091-10623320091101 VIAL, MULTI-DOSE in 1 CARTON (62332-091-10) / 10 mL in 1 VIAL, MULTI-DOSE2025-10-17NoNoCurrent