CALCITONIN SALMON injection, solution

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1971-1

Calcitonin Salmon Injection, USP, Synthetic

400 USP Units/2 mL (200 USP Units/mL)

For Intramuscular or Subcutaneous Use

2 mL Multiple-Dose vial

Rx only

INGREDIENTS AND APPEARANCE

CALCITONIN SALMON 
calcitonin salmon injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1971
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCITONIN SALMON (UNII: 7SFC6U2VI5) (CALCITONIN SALMON - UNII:7SFC6U2VI5)	CALCITONIN SALMON	200 [USP'U]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
PHENOL (UNII: 339NCG44TV)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1971-1	1 in 1 CARTON	04/10/2026
1		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215864	04/10/2026

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1971) , ANALYSIS(70771-1971) , API MANUFACTURE(70771-1971)