increlex

Generic: mecasermin

Labeler: eton pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name increlex
Generic Name mecasermin
Labeler eton pharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

mecasermin 40 mg/4mL

Manufacturer
Eton Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71863-216
Product ID 71863-216_3b2a53e0-f43e-4f64-e063-6294a90af024
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021839
Listing Expiration 2026-12-31
Marketing Start 2025-04-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71863216
Hyphenated Format 71863-216

Supplemental Identifiers

RxCUI
604806 615882
UNII
7GR9I2683O

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 increlex (source: ndc)
Generic Name mecasermin (source: ndc)
Application Number BLA021839 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/4mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04) / 4 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

71863-216-04 1 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04) / 4 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

mecasermin (40 mg/4mL)

Linked Drug Pages (1)

Increlex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3b2a53e0-f43e-4f64-e063-6294a90af024", "openfda": {"unii": ["7GR9I2683O"], "rxcui": ["604806", "615882"], "spl_set_id": ["d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce"], "manufacturer_name": ["Eton Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71863-216-04", "marketing_start_date": "20250416"}], "brand_name": "Increlex", "product_id": "71863-216_3b2a53e0-f43e-4f64-e063-6294a90af024", "dosage_form": "INJECTION", "product_ndc": "71863-216", "generic_name": "Mecasermin", "labeler_name": "Eton Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Increlex", "active_ingredients": [{"name": "MECASERMIN", "strength": "40 mg/4mL"}], "application_number": "BLA021839", "marketing_category": "BLA", "marketing_start_date": "20250416", "listing_expiration_date": "20261231"}