ngenla

Generic: somatrogon-ghla

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ngenla
Generic Name somatrogon-ghla
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

somatrogon 60 mg/1.2mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0520
Product ID 0069-0520_6e73b67b-0cab-4f0d-95b9-67579f00aa7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761184
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

Classes
11-beta hydroxysteroid dehydrogenase type 1 inhibitors [moa] human growth hormone [cs] recombinant human growth hormone [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690520
Hyphenated Format 0069-0520

Supplemental Identifiers

RxCUI
2644517 2644523 2644526 2644529
UNII
6D848RA61B

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 ngenla (source: ndc)
Generic Name somatrogon-ghla (source: ndc)
Application Number BLA761184 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/1.2mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01)
source: ndc

Packages (1)

0069-0520-02 1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01)

Ingredients (1)

somatrogon (60 mg/1.2mL)

Linked Drug Pages (1)

Ngenla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "6e73b67b-0cab-4f0d-95b9-67579f00aa7f", "openfda": {"unii": ["6D848RA61B"], "rxcui": ["2644517", "2644523", "2644526", "2644529"], "spl_set_id": ["06dce529-b741-4a1b-8842-3ad77be6e308"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0069-0520-02)  / 1.2 mL in 1 CARTRIDGE (0069-0520-01)", "package_ndc": "0069-0520-02", "marketing_start_date": "20230731"}], "brand_name": "Ngenla", "product_id": "0069-0520_6e73b67b-0cab-4f0d-95b9-67579f00aa7f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA]", "Human Growth Hormone [CS]", "Recombinant Human Growth Hormone [EPC]"], "product_ndc": "0069-0520", "generic_name": "somatrogon-ghla", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ngenla", "active_ingredients": [{"name": "SOMATROGON", "strength": "60 mg/1.2mL"}], "application_number": "BLA761184", "marketing_category": "BLA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}