norditropin

Generic: somatropin

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

Drug Facts

Product Profile

Brand Name norditropin
Generic Name somatropin
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

somatropin 10 mg/1.5mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-7705
Product ID 0169-7705_b67c2419-4feb-4ce1-b97e-88760a8e1aee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021148
Listing Expiration 2026-12-31
Marketing Start 2006-01-02

Pharmacologic Class

Established (EPC)
recombinant human growth hormone [epc]
Chemical Structure
human growth hormone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01697705
Hyphenated Format 0169-7705

Supplemental Identifiers

RxCUI
847243 847245 847247 847348 849850 849851 1736262 1736329
UNII
NQX9KB6PCL
NUI
N0000175606 M0028842

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 norditropin (source: ndc)
Generic Name somatropin (source: ndc)
Application Number BLA021148 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/1.5mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-21) / 1.5 mL in 1 SYRINGE, PLASTIC
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-92) / 1.5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (2)

0169-7705-21 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-21) / 1.5 mL in 1 SYRINGE, PLASTIC 0169-7705-92 1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-92) / 1.5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

somatropin (10 mg/1.5mL)

Linked Drug Pages (1)

Norditropin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b67c2419-4feb-4ce1-b97e-88760a8e1aee", "openfda": {"nui": ["N0000175606", "M0028842"], "unii": ["NQX9KB6PCL"], "rxcui": ["847243", "847245", "847247", "847348", "849850", "849851", "1736262", "1736329"], "spl_set_id": ["1058e17c-9261-459c-a3e6-fae38d196c14"], "pharm_class_cs": ["Human Growth Hormone [CS]"], "pharm_class_epc": ["Recombinant Human Growth Hormone [EPC]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-21)  / 1.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-7705-21", "marketing_start_date": "20100301"}, {"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-7705-92)  / 1.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-7705-92", "marketing_start_date": "20100301"}], "brand_name": "Norditropin", "product_id": "0169-7705_b67c2419-4feb-4ce1-b97e-88760a8e1aee", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Human Growth Hormone [CS]", "Recombinant Human Growth Hormone [EPC]"], "product_ndc": "0169-7705", "generic_name": "somatropin", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norditropin", "active_ingredients": [{"name": "SOMATROPIN", "strength": "10 mg/1.5mL"}], "application_number": "BLA021148", "marketing_category": "BLA", "marketing_start_date": "20060102", "listing_expiration_date": "20261231"}