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 KIT
Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-4004
Product ID 0781-4004_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 07814004
Hyphenated Format 0781-4004

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: label

Resolved Composition

Strengths
  • 5 mg/1.5 ml
  • 10 mg/1.5 ml
  • 5.8 mg
  • 1.5 %
source: label
Packaging
  • 1 KIT in 1 CARTON (0781-4004-36) * 1 mL in 1 VIAL (0781-4014-71) * 1.14 mL in 1 VIAL (0781-4024-72)
source: ndc

Packages (1)

0781-4004-36 1 KIT in 1 CARTON (0781-4004-36) * 1 mL in 1 VIAL (0781-4014-71) * 1.14 mL in 1 VIAL (0781-4024-72)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Omnitrope ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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 KIT in 1 CARTON (0781-4004-36)  *  1 mL in 1 VIAL (0781-4014-71)  *  1.14 mL in 1 VIAL (0781-4024-72)", "package_ndc": "0781-4004-36", "marketing_start_date": "20060530"}], "brand_name": "Omnitrope", "product_id": "0781-4004_4285f380-615e-420b-b756-1e0a775f785b", "dosage_form": "KIT", "product_ndc": "0781-4004", "generic_name": "Somatropin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omnitrope", "application_number": "BLA021426", "marketing_category": "BLA", "marketing_start_date": "20060530", "listing_expiration_date": "20261231"}