miacalcin

Generic: calcitonin salmon

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miacalcin
Generic Name calcitonin salmon
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

calcitonin salmon 200 [USP'U]/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 72078-038
Product ID 72078-038_d54536c6-69ce-48d4-b2fc-6019cb9d09b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017808
Listing Expiration 2026-12-31
Marketing Start 2022-06-16

Pharmacologic Class

Established (EPC)
calcitonin [epc]
Chemical Structure
calcitonin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72078038
Hyphenated Format 72078-038

Supplemental Identifiers

RxCUI
213570 308866
UPC
0372078038026
UNII
7SFC6U2VI5
NUI
M0003145 N0000175942

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name miacalcin (source: ndc)
Generic Name calcitonin salmon (source: ndc)
Application Number NDA017808 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 [USP'U]/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

72078-038-02 1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

calcitonin salmon (200 [USP'U]/mL)

Linked Drug Pages (1)

Miacalcin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "d54536c6-69ce-48d4-b2fc-6019cb9d09b6", "openfda": {"nui": ["M0003145", "N0000175942"], "upc": ["0372078038026"], "unii": ["7SFC6U2VI5"], "rxcui": ["213570", "308866"], "spl_set_id": ["753ecc6a-07be-4fc6-9032-cc6ad116a662"], "pharm_class_cs": ["Calcitonin [CS]"], "pharm_class_epc": ["Calcitonin [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "72078-038-02", "marketing_start_date": "20220616"}], "brand_name": "Miacalcin", "product_id": "72078-038_d54536c6-69ce-48d4-b2fc-6019cb9d09b6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcitonin [CS]", "Calcitonin [EPC]"], "product_ndc": "72078-038", "generic_name": "calcitonin salmon", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Miacalcin", "active_ingredients": [{"name": "CALCITONIN SALMON", "strength": "200 [USP'U]/mL"}], "application_number": "NDA017808", "marketing_category": "NDA", "marketing_start_date": "20220616", "listing_expiration_date": "20261231"}