FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
46708-812
11-digit product format
467080812
Labeler code
46708
Product ID
46708-812_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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-812-01Triamcinolone Acetonide1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION11
46708-812-01Triamcinolone Acetonide1 in 1 CARTONINJECTION, SUSPENSION11
46708-812-25Triamcinolone Acetonide25 in 1 CARTONINJECTION, SUSPENSION251
46708-812-25Triamcinolone Acetonide1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION11

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
46708-812-01467080812011 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-10-17NoNoCurrent
46708-812-254670808122525 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-25) / 1 mL in 1 VIAL, SINGLE-DOSE2025-10-17NoNoCurrent