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
d371f0f7-d492-4481-b360-051456d56d65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-1106
Application NumberANDA208569
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriparatide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 1, 2021
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TERIPARATIDE ACETATEActive
Quantity: 250 ug in 1 mL
Code: 9959P4V12N
Classification: ACTIM
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT