ziextenzo

Generic: pegfilgrastim-bmez

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ziextenzo
Generic Name pegfilgrastim-bmez
Labeler sandoz inc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

pegfilgrastim 6 mg/.6mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-866
Product ID 61314-866_1043b30b-ea11-4192-8871-cea86bc8529c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761045
Listing Expiration 2026-12-31
Marketing Start 2019-11-04

Pharmacologic Class

Established (EPC)
leukocyte growth factor [epc]
Chemical Structure
granulocyte colony-stimulating factor [cs]
Physiologic Effect
increased myeloid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314866
Hyphenated Format 61314-866

Supplemental Identifiers

RxCUI
2260704 2260709
UNII
3A58010674
NUI
M0024696 N0000009451 N0000175666

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 ziextenzo (source: ndc)
Generic Name pegfilgrastim-bmez (source: ndc)
Application Number BLA761045 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.6mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (61314-866-02) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
source: ndc

Packages (1)

61314-866-02 1 BLISTER PACK in 1 CARTON (61314-866-02) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

Ingredients (1)

pegfilgrastim (6 mg/.6mL)

Linked Drug Pages (1)

ZIEXTENZO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1043b30b-ea11-4192-8871-cea86bc8529c", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["3A58010674"], "rxcui": ["2260704", "2260709"], "spl_set_id": ["7dada041-6528-4acf-809c-62d271538c9a"], "pharm_class_cs": ["Granulocyte Colony-Stimulating Factor [CS]"], "pharm_class_pe": ["Increased Myeloid Cell Production [PE]"], "pharm_class_epc": ["Leukocyte Growth Factor [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (61314-866-02)  / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE", "package_ndc": "61314-866-02", "marketing_start_date": "20250303"}], "brand_name": "ZIEXTENZO", "product_id": "61314-866_1043b30b-ea11-4192-8871-cea86bc8529c", "dosage_form": "INJECTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "61314-866", "generic_name": "pegfilgrastim-bmez", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIEXTENZO", "active_ingredients": [{"name": "PEGFILGRASTIM", "strength": "6 mg/.6mL"}], "application_number": "BLA761045", "marketing_category": "BLA", "marketing_start_date": "20191104", "listing_expiration_date": "20261231"}