calcitonin salmon

Generic: calcitonin salmon

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitonin salmon
Generic Name calcitonin salmon
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

calcitonin salmon 200 [iU]/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-865
Product ID 63323-865_19ca702a-a90d-4baa-96dd-17e6dc3517f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212675
Listing Expiration 2026-12-31
Marketing Start 2024-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323865
Hyphenated Format 63323-865

Supplemental Identifiers

RxCUI
308866
UPC
0363323865023
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 calcitonin salmon (source: ndc)
Generic Name calcitonin salmon (source: ndc)
Application Number ANDA212675 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 [iU]/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02) / 2 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63323-865-02 1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02) / 2 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

calcitonin salmon (200 [iU]/mL)

Linked Drug Pages (1)

Calcitonin Salmon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "19ca702a-a90d-4baa-96dd-17e6dc3517f3", "openfda": {"nui": ["M0003145", "N0000175942"], "upc": ["0363323865023"], "unii": ["7SFC6U2VI5"], "rxcui": ["308866"], "spl_set_id": ["2b8c6917-c217-45bf-a0ac-a2fa0f7d497a"], "pharm_class_cs": ["Calcitonin [CS]"], "pharm_class_epc": ["Calcitonin [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-865-02", "marketing_start_date": "20241205"}], "brand_name": "Calcitonin Salmon", "product_id": "63323-865_19ca702a-a90d-4baa-96dd-17e6dc3517f3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcitonin [CS]", "Calcitonin [EPC]"], "product_ndc": "63323-865", "generic_name": "Calcitonin Salmon", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitonin Salmon", "active_ingredients": [{"name": "CALCITONIN SALMON", "strength": "200 [iU]/mL"}], "application_number": "ANDA212675", "marketing_category": "ANDA", "marketing_start_date": "20241205", "listing_expiration_date": "20261231"}