omnitrope

Generic: somatropin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name omnitrope
Generic Name somatropin
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

somatropin 10 mg/1.5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3004
Product ID 0781-3004_4285f380-615e-420b-b756-1e0a775f785b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021426
Listing Expiration 2026-12-31
Marketing Start 2006-05-30

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 07813004
Hyphenated Format 0781-3004

Supplemental Identifiers

RxCUI
241975 645884 854302 864110 1736267 1736337
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 omnitrope (source: ndc)
Generic Name somatropin (source: ndc)
Application Number BLA021426 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/1.5mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (0781-3004-07) / 1.5 mL in 1 CARTRIDGE
  • 5 CARTRIDGE in 1 CARTON (0781-3004-26) / 1.5 mL in 1 CARTRIDGE
source: ndc

Packages (2)

0781-3004-07 1 CARTRIDGE in 1 CARTON (0781-3004-07) / 1.5 mL in 1 CARTRIDGE 0781-3004-26 5 CARTRIDGE in 1 CARTON (0781-3004-26) / 1.5 mL in 1 CARTRIDGE

Ingredients (1)

somatropin (10 mg/1.5mL)

Linked Drug Pages (1)

Omnitrope ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4285f380-615e-420b-b756-1e0a775f785b", "openfda": {"nui": ["N0000175606", "M0028842"], "unii": ["NQX9KB6PCL"], "rxcui": ["241975", "645884", "854302", "864110", "1736267", "1736337"], "spl_set_id": ["58d84ffa-4056-4e36-ad67-7bd4aef444a5"], "pharm_class_cs": ["Human Growth Hormone [CS]"], "pharm_class_epc": ["Recombinant Human Growth Hormone [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0781-3004-07)  / 1.5 mL in 1 CARTRIDGE", "package_ndc": "0781-3004-07", "marketing_start_date": "20060530"}, {"sample": false, "description": "5 CARTRIDGE in 1 CARTON (0781-3004-26)  / 1.5 mL in 1 CARTRIDGE", "package_ndc": "0781-3004-26", "marketing_start_date": "20060530"}], "brand_name": "Omnitrope", "product_id": "0781-3004_4285f380-615e-420b-b756-1e0a775f785b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Human Growth Hormone [CS]", "Recombinant Human Growth Hormone [EPC]"], "product_ndc": "0781-3004", "generic_name": "Somatropin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omnitrope", "active_ingredients": [{"name": "SOMATROPIN", "strength": "10 mg/1.5mL"}], "application_number": "BLA021426", "marketing_category": "BLA", "marketing_start_date": "20060530", "listing_expiration_date": "20261231"}