paclitaxel

Generic: paclitaxel

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

Drug Facts

Product Profile

Brand Name paclitaxel
Generic Name paclitaxel
Labeler sandoz inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 100 mg/20mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3531
Product ID 0781-3531_374cacf2-c5ef-4958-e063-6294a90a5b3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212700
Listing Expiration 2026-12-31
Marketing Start 2024-10-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813531
Hyphenated Format 0781-3531

Supplemental Identifiers

RxCUI
583214
UPC
0307813531913
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 ANDA212700 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0781-3531-91 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSE

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": "374cacf2-c5ef-4958-e063-6294a90a5b3c", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0307813531913"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["15ca4829-8fee-45f9-b4bc-b31c15732cd6"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3531-91", "marketing_start_date": "20241009"}], "brand_name": "Paclitaxel", "product_id": "0781-3531_374cacf2-c5ef-4958-e063-6294a90a5b3c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0781-3531", "generic_name": "Paclitaxel", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "ANDA212700", "marketing_category": "ANDA", "marketing_start_date": "20241008", "listing_expiration_date": "20261231"}