levemir

Generic: insulin detemir

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name levemir
Generic Name insulin detemir
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin detemir 100 [iU]/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-3687
Product ID 0169-3687_f474a2c6-c2fe-4dec-86a9-7fc2aef980f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021536
Marketing Start 2006-03-27
Marketing End 2026-08-31

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01693687
Hyphenated Format 0169-3687

Supplemental Identifiers

RxCUI
484322 616238 847239 847241
UNII
4FT78T86XV
NUI
N0000004931 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 levemir (source: ndc)
Generic Name insulin detemir (source: ndc)
Application Number BLA021536 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0169-3687-12) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0169-3687-12 1 VIAL, GLASS in 1 CARTON (0169-3687-12) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

insulin detemir (100 [iU]/mL)

Linked Drug Pages (1)

Levemir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f474a2c6-c2fe-4dec-86a9-7fc2aef980f3", "openfda": {"nui": ["N0000004931", "N0000175453"], "unii": ["4FT78T86XV"], "rxcui": ["484322", "616238", "847239", "847241"], "spl_set_id": ["d38d65c1-25bf-401d-9c7e-a2c3222da8af"], "pharm_class_cs": ["Insulin [Chemical/Ingredient]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0169-3687-12)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0169-3687-12", "marketing_end_date": "20260831", "marketing_start_date": "20060327"}], "brand_name": "Levemir", "product_id": "0169-3687_f474a2c6-c2fe-4dec-86a9-7fc2aef980f3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [Chemical/Ingredient]"], "product_ndc": "0169-3687", "generic_name": "insulin detemir", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levemir", "active_ingredients": [{"name": "INSULIN DETEMIR", "strength": "100 [iU]/mL"}], "application_number": "BLA021536", "marketing_category": "BLA", "marketing_end_date": "20260831", "marketing_start_date": "20060327"}