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Omnitrope

Somatropin · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Omnitrope
Generic name
Somatropin
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Sandoz Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Somatropin 10 mg/1.5mL 847243 View
Somatropin 5 mg/1.5mL 847243 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Human Growth Hormone [CS] CS 4 members — no class page
Recombinant Human Growth Hormone [EPC] EPC 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021426
Application type
BLA · Biologics License Application
Approval date
May 30, 2006
Sponsor
SANDOZ
Products on application
4
Submissions recorded
20
Products approved under application 021426.
Product Trade name Form Strength Ingredient Status TE Flags
021426-001 OMNITROPE INJECTABLE SOMATROPIN Prescription —
021426-002 OMNITROPE INJECTABLE SOMATROPIN Prescription —
021426-003 OMNITROPE INJECTABLE SOMATROPIN Prescription —
021426-004 OMNITROPE INJECTABLE SOMATROPIN Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 021426.
Type No. Action Status Date Review
Supplement 62 Labeling Approved July 9, 2025 Standard
Supplement 58 Labeling Approved November 12, 2024 Standard
Supplement 43 Labeling Approved November 12, 2024 Standard
Supplement 50 Manufacturing (CMC) Approved January 25, 2022 N/A
Supplement 22 Labeling Approved February 15, 2017 Standard
Supplement 34 Labeling Approved December 13, 2016 Standard
Supplement 28 Labeling Approved August 29, 2014 Standard
Supplement 29 Manufacturing (CMC) Approved July 14, 2014 Standard
Supplement 27 Manufacturing (CMC) Approved August 22, 2013 Standard
Supplement 25 Manufacturing (CMC) Approved June 18, 2013 Standard
Supplement 23 Manufacturing (CMC) Approved April 4, 2013 Standard
Supplement 17 Efficacy Approved July 22, 2011 Standard
Supplement 18 Labeling Approved April 13, 2011 Unknown
Supplement 15 Efficacy Approved August 26, 2010 Standard
Supplement 8 Efficacy Approved April 23, 2010 Standard
Supplement 7 Efficacy Approved April 23, 2010 Standard
Supplement 6 Manufacturing (CMC) Approved March 25, 2009 N/A
Supplement 4 Manufacturing (CMC) Approved August 25, 2008 N/A
Supplement 2 Manufacturing (CMC) Approved January 16, 2008 N/A
Original application 1 Type 5 - New Formulation or New Manufacturer Approved May 30, 2006 Standard

Review documents

  • 0 · Supplement · July 11, 2025
  • 0 · Supplement · July 11, 2025
  • 0 · Supplement · November 13, 2024
  • 0 · Supplement · November 13, 2024
  • 0 · Supplement · November 13, 2024
  • 0 · Supplement · January 28, 2022
  • 0 · Original application · March 4, 2021
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Original application · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Original application · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Original application · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020
  • 0 · Supplement · March 23, 2020

Adverse event reports

Source: openFDA FAERS
73,543
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SOMATROPIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0781-3001-07 0781-3001 Sandoz Inc 1 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGE May 30, 2006
0781-3001-26 0781-3001 Sandoz Inc 5 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGE May 30, 2006
0781-3004-07 0781-3004 Sandoz Inc 1 CARTRIDGE in 1 CARTON (0781-3004-07) / 1.5 mL in 1 CARTRIDGE May 30, 2006
0781-3004-26 0781-3004 Sandoz Inc 5 CARTRIDGE in 1 CARTON (0781-3004-26) / 1.5 mL in 1 CARTRIDGE May 30, 2006
0781-3001 0781-3001 Sandoz Inc — May 30, 2006
0781-3004 0781-3004 Sandoz Inc — May 30, 2006

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.