Legend
Legend (hyaluronate sodium) Injectable Solution
Approved
Approval ID
e3c095a2-6bbe-4b47-96e2-c2ac73b53eaf
Product Type
PRESCRIPTION ANIMAL DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Boehringer Ingelheim Animal Health USA Inc.
DUNS: 007134091
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hyaluronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0010-3140
Application NumberNADA140883
Product Classification
M
Marketing Category
C73593
G
Generic Name
hyaluronate sodium
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRAVENOUS
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (4)
hyaluronate sodiumActive
Quantity: 10 mg in 1 mL
Code: YSE9PPT4TH
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 0.223 mg in 1 mL
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Quantity: 0.04 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT