Triamcinolone Acetonide
Triamcinolone Acetonide Injectable Suspension, USP NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL For Intramuscular or Intra-articular Use Only NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE
Approved
Approval ID
5f3aaf3a-cc66-4d4f-b9b7-2c50c325d477
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-150
Application NumberANDA207550
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRAMUSCULAR
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (7)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 400 mg in 10 mL
Code: F446C597KA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-130
Application NumberANDA207550
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRAMUSCULAR
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (7)
TRIAMCINOLONE ACETONIDEActive
Quantity: 40 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-140
Application NumberANDA207550
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRAMUSCULAR
Effective DateJanuary 23, 2024
FDA Product Classification
INGREDIENTS (7)
TRIAMCINOLONE ACETONIDEActive
Quantity: 200 mg in 5 mL
Code: F446C597KA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT