teriparatide
These highlights do not include all the information needed to use TERIPARATIDE INJECTION safely and effectively. See full prescribing information for TERIPARATIDE INJECTION. TERIPARATIDE injection, for subcutaneous useInitial U.S. Approval: 1987
Approved
Approval ID
1b007339-dd0d-f019-5e0a-9b1b0f75011c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Alvogen, Inc.
DUNS: 008057330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
teriparatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47781-652
Application NumberNDA211939
Product Classification
M
Marketing Category
C73594
G
Generic Name
teriparatide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 22, 2017
FDA Product Classification
INGREDIENTS (6)
TERIPARATIDEActive
Quantity: 250 ug in 1 mL
Code: 10T9CSU89I
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT