paclitaxel

Generic: paclitaxel

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel
Generic Name paclitaxel
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-937
Product ID 67457-937_eea70833-792a-4f73-be95-9cd252c1478e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217877
Listing Expiration 2026-12-31
Marketing Start 2025-10-09

Pharmacologic Class

Established (EPC)
microtubule inhibitor [epc]
Physiologic Effect
microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457937
Hyphenated Format 67457-937

Supplemental Identifiers

RxCUI
583214
UNII
P88XT4IS4D
NUI
N0000175085 N0000175592

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 paclitaxel (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number ANDA217877 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 20 mL in 1 VIAL (67457-937-50)
source: ndc

Packages (1)

67457-937-50 20 mL in 1 VIAL (67457-937-50)

Ingredients (1)

paclitaxel (100 mg/20mL)

Linked Drug Pages (1)

PACLITAXEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "eea70833-792a-4f73-be95-9cd252c1478e", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["a1a06de1-d9a4-460a-b87d-5e40305b065c"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL (67457-937-50)", "package_ndc": "67457-937-50", "marketing_start_date": "20251009"}], "brand_name": "PACLITAXEL", "product_id": "67457-937_eea70833-792a-4f73-be95-9cd252c1478e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "67457-937", "generic_name": "PACLITAXEL", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PACLITAXEL", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "ANDA217877", "marketing_category": "ANDA", "marketing_start_date": "20251009", "listing_expiration_date": "20261231"}