novolin r

Generic: human insulin

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

Drug Facts

Product Profile

Brand Name novolin r
Generic Name human insulin
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin human 100 [iU]/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-3003
Product ID 0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
Product Type HUMAN OTC DRUG
Marketing Category BLA
Application Number BLA019938
Listing Expiration 2026-12-31
Marketing Start 2019-09-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01693003
Hyphenated Format 0169-3003

Supplemental Identifiers

RxCUI
311033 311034 2206090 2206092
UNII
1Y17CTI5SR
NUI
M0011417 N0000175944

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 novolin r (source: ndc)
Generic Name human insulin (source: ndc)
Application Number BLA019938 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01)
  • 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12)
source: ndc

Packages (2)

0169-3003-15 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01) 0169-3003-25 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12)

Ingredients (1)

insulin human (100 [iU]/mL)

Linked Drug Pages (1)

Novolin R ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "46700b71-3f26-4aaa-8eb7-6ceeeb515c79", "openfda": {"nui": ["M0011417", "N0000175944"], "unii": ["1Y17CTI5SR"], "rxcui": ["311033", "311034", "2206090", "2206092"], "spl_set_id": ["aee7f1f3-612c-4027-8ce9-4fd1f41eed71"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin [EPC]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15)  / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01)", "package_ndc": "0169-3003-15", "marketing_start_date": "20190906"}, {"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25)  / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12)", "package_ndc": "0169-3003-25", "marketing_start_date": "20190906"}], "brand_name": "Novolin R", "product_id": "0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin [CS]", "Insulin [EPC]"], "product_ndc": "0169-3003", "generic_name": "Human Insulin", "labeler_name": "Novo Nordisk", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Novolin", "brand_name_suffix": "R", "active_ingredients": [{"name": "INSULIN HUMAN", "strength": "100 [iU]/mL"}], "application_number": "BLA019938", "marketing_category": "BLA", "marketing_start_date": "20190906", "listing_expiration_date": "20261231"}