paclitaxel

Generic: paclitaxel

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel
Generic Name paclitaxel
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 6 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-255
Product ID 25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207326
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021255
Hyphenated Format 25021-255

Supplemental Identifiers

RxCUI
312199
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 ANDA207326 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-255-05) / 5 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-255-17) / 16.7 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-255-50) / 50 mL in 1 VIAL
source: ndc

Packages (3)

25021-255-05 1 VIAL in 1 CARTON (25021-255-05) / 5 mL in 1 VIAL 25021-255-17 1 VIAL in 1 CARTON (25021-255-17) / 16.7 mL in 1 VIAL 25021-255-50 1 VIAL in 1 CARTON (25021-255-50) / 50 mL in 1 VIAL

Ingredients (1)

paclitaxel (6 mg/mL)

Linked Drug Pages (1)

Paclitaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5f3284c1-d03f-4fca-bb78-1ead3280af60", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["312199"], "spl_set_id": ["5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-255-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-255-05", "marketing_start_date": "20240201"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-255-17)  / 16.7 mL in 1 VIAL", "package_ndc": "25021-255-17", "marketing_start_date": "20240201"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-255-50)  / 50 mL in 1 VIAL", "package_ndc": "25021-255-50", "marketing_start_date": "20240201"}], "brand_name": "Paclitaxel", "product_id": "25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "25021-255", "generic_name": "Paclitaxel", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "6 mg/mL"}], "application_number": "ANDA207326", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}