voxzogo 0.4mg

Generic: vosoritide

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name voxzogo 0.4mg
Generic Name vosoritide
Labeler biomarin pharmaceutical inc.
Dosage Form KIT
Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-082
Product ID 68135-082_6100caa6-4951-4773-b80c-6be0c04efd24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214938
Listing Expiration 2026-12-31
Marketing Start 2021-11-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135082
Hyphenated Format 68135-082

Supplemental Identifiers

RxCUI
2586364 2586369 2586371 2586373 2586375 2586377

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 voxzogo 0.4mg (source: ndc)
Generic Name vosoritide (source: ndc)
Application Number NDA214938 (source: ndc)

Resolved Composition

Strengths
  • 0.4 mg
  • 0.56 mg
  • 1.2 mg
  • 2 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)
source: ndc

Packages (1)

68135-082-36 1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VOXZOGO 0.4mg, VOXZOGO 0.56mg, VOXZOGO 1.2mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "6100caa6-4951-4773-b80c-6be0c04efd24", "openfda": {"rxcui": ["2586364", "2586369", "2586371", "2586373", "2586375", "2586377"], "spl_set_id": ["228e8560-04a4-4bb1-a81f-29531a9e4d27"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (68135-082-36)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00)  / .5 mL in 1 VIAL, SINGLE-DOSE *  10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)", "package_ndc": "68135-082-36", "marketing_start_date": "20211119"}], "brand_name": "VOXZOGO 0.4mg", "product_id": "68135-082_6100caa6-4951-4773-b80c-6be0c04efd24", "dosage_form": "KIT", "product_ndc": "68135-082", "generic_name": "vosoritide", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VOXZOGO 0.4mg", "application_number": "NDA214938", "marketing_category": "NDA", "marketing_start_date": "20211119", "listing_expiration_date": "20261231"}