levemir

Generic: insulin detemir

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name levemir
Generic Name insulin detemir
Labeler a-s medication solutions
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin detemir 100 [iU]/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6391
Product ID 50090-6391_9736dfc4-160a-4df2-8524-4419fea3403b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021536
Listing Expiration 2026-12-31
Marketing Start 2013-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906391
Hyphenated Format 50090-6391

Supplemental Identifiers

RxCUI
847239 847241
UNII
4FT78T86XV
NUI
N0000004931 N0000175453

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
  • 5 SYRINGE, PLASTIC in 1 CARTON (50090-6391-0) / 3 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

50090-6391-0 5 SYRINGE, PLASTIC in 1 CARTON (50090-6391-0) / 3 mL in 1 SYRINGE, PLASTIC

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": "9736dfc4-160a-4df2-8524-4419fea3403b", "openfda": {"nui": ["N0000004931", "N0000175453"], "unii": ["4FT78T86XV"], "rxcui": ["847239", "847241"], "spl_set_id": ["35e31793-9df4-4773-82b2-59678d8652bf"], "pharm_class_cs": ["Insulin [Chemical/Ingredient]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (50090-6391-0)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "50090-6391-0", "marketing_start_date": "20230309"}], "brand_name": "LEVEMIR", "product_id": "50090-6391_9736dfc4-160a-4df2-8524-4419fea3403b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [Chemical/Ingredient]"], "product_ndc": "50090-6391", "generic_name": "insulin detemir", "labeler_name": "A-S Medication Solutions", "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_start_date": "20131031", "listing_expiration_date": "20261231"}