Teriparatide

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

006421325

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

66993-495

Application Number

NDA021318

Marketing Category

NDA authorized generic (C73605)

Route of Administration

SUBCUTANEOUS

Effective Date

November 17, 2023

Ingredients

sodium acetate anhydrousInactive

Code: NVG71ZZ7P0Class: IACTQuantity: 0.1 mg in 1 mL

acetic acidInactive

Code: Q40Q9N063PClass: IACTQuantity: 0.41 mg in 1 mL

Code: 10T9CSU89IClass: ACTIBQuantity: 250 ug in 1 mL

mannitolInactive

Code: 3OWL53L36AClass: IACTQuantity: 45.4 mg in 1 mL

MetacresolInactive

Code: GGO4Y809LOClass: IACTQuantity: 3.0 mg in 1 mL

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT