FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
46708-091
Requested package NDC
46708-091-10
11-digit product format
467080091
Labeler code
46708
Product ID
46708-091_c0b487dd-a47b-42fd-a855-5d237c5651a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRAMUSCULAR
Labeler
Alembic Pharmaceuticals Limited
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 43.

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
2026-09-14 22:38:342026-08A218601-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-1784e616aacf4f…
2026-08-18 06:07:402026-07A218601-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2025-10-17caaa826d4ba7…
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
2026-09-14 22:38:342026-08A218601-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218601-001AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c0b487dd-a47b-42fd-a855-5d237c5651a9Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-091-10Triamcinolone Acetonide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION101
46708-091-10Triamcinolone Acetonide1 in 1 CARTONINJECTION, SUSPENSION11

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-b626-97fbb8f01b492026-08-14Warnings, 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
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Limitedc0b487dd-a47b-42fd-a855-5d237c5651a92025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218601
application number: ANDA218601
ndc (package): 46708-091-10
ndc (product): 46708-091
ndc11 (package): 46708009110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSNc0b487dd-a47b-42fd-a855-5d237c5651a91
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSNc0b487dd-a47b-42fd-a855-5d237c5651a91
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCDc0b487dd-a47b-42fd-a855-5d237c5651a91
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCDc0b487dd-a47b-42fd-a855-5d237c5651a91
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSYc0b487dd-a47b-42fd-a855-5d237c5651a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-091-10467080091101 VIAL, MULTI-DOSE in 1 CARTON (46708-091-10) / 10 mL in 1 VIAL, MULTI-DOSE2025-10-17NoNoCurrent