paclitaxel

Generic: paclitaxel

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel
Generic Name paclitaxel
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 6 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-763
Product ID 63323-763_11fa3178-16bd-4da3-b276-079ce8e12efb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077574
Listing Expiration 2026-12-31
Marketing Start 2009-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323763
Hyphenated Format 63323-763

Supplemental Identifiers

RxCUI
312199
UPC
0363323763503 0363323763169
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 ANDA077574 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

63323-763-16 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSE 63323-763-50 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSE

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": "11fa3178-16bd-4da3-b276-079ce8e12efb", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0363323763503", "0363323763169"], "unii": ["P88XT4IS4D"], "rxcui": ["312199"], "spl_set_id": ["a6c24189-293f-42ca-b969-75870bb55af0"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16)  / 16.7 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-763-16", "marketing_start_date": "20090320"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-763-50", "marketing_start_date": "20090320"}], "brand_name": "Paclitaxel", "product_id": "63323-763_11fa3178-16bd-4da3-b276-079ce8e12efb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "63323-763", "generic_name": "Paclitaxel", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "6 mg/mL"}], "application_number": "ANDA077574", "marketing_category": "ANDA", "marketing_start_date": "20090320", "listing_expiration_date": "20261231"}