paclitaxel

Generic: paclitaxel

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

paclitaxel 100 mg/20mL

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3290
Product ID 0480-3290_2fbc2699-cf99-497c-94b9-8a2c534c061f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216338
Listing Expiration 2027-12-31
Marketing Start 2024-07-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803290
Hyphenated Format 0480-3290

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 NDA216338 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0480-3290-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01) / 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": "2fbc2699-cf99-497c-94b9-8a2c534c061f", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["583214"], "spl_set_id": ["15dd51ed-29e8-468b-b6d1-21b1f84d6f2e"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0480-3290-01", "marketing_start_date": "20240702"}], "brand_name": "Paclitaxel", "product_id": "0480-3290_2fbc2699-cf99-497c-94b9-8a2c534c061f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0480-3290", "generic_name": "Paclitaxel", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "100 mg/20mL"}], "application_number": "NDA216338", "marketing_category": "NDA", "marketing_start_date": "20240702", "listing_expiration_date": "20271231"}