insulin degludec

Generic: insulin degludec

Labeler: novo nordisk pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name insulin degludec
Generic Name insulin degludec
Labeler novo nordisk pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin degludec 100 U/mL

Manufacturer
Novo Nordisk Pharma, Inc.

Identifiers & Regulatory

Product NDC 73070-403
Product ID 73070-403_c1be283d-4b1d-4996-b2a7-4488dbff3037
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA203314
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73070403
Hyphenated Format 73070-403

Supplemental Identifiers

RxCUI
1670011 1670021 2107520
UNII
54Q18076QB
NUI
M0011417 N0000175453

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 insulin degludec (source: ndc)
Generic Name insulin degludec (source: ndc)
Application Number BLA203314 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 U/mL
source: ndc
Packaging
  • 5 SYRINGE, PLASTIC in 1 CARTON (73070-403-15) / 3 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

73070-403-15 5 SYRINGE, PLASTIC in 1 CARTON (73070-403-15) / 3 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

insulin degludec (100 U/mL)

Linked Drug Pages (1)

Insulin Degludec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "c1be283d-4b1d-4996-b2a7-4488dbff3037", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["54Q18076QB"], "rxcui": ["1670011", "1670021", "2107520"], "spl_set_id": ["c1be283d-4b1d-4996-b2a7-4488dbff3037"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Novo Nordisk Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (73070-403-15)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "73070-403-15", "marketing_start_date": "20220701"}], "brand_name": "Insulin Degludec", "product_id": "73070-403_c1be283d-4b1d-4996-b2a7-4488dbff3037", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "73070-403", "generic_name": "insulin degludec", "labeler_name": "Novo Nordisk Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Insulin Degludec", "active_ingredients": [{"name": "INSULIN DEGLUDEC", "strength": "100 U/mL"}], "application_number": "BLA203314", "marketing_category": "BLA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}