docetaxel

Generic: docetaxel

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 20 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-323
Product ID 47335-323_9a0d7b91-4324-4e19-9cd8-eb19266e771a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022534
Listing Expiration 2026-12-31
Marketing Start 2020-11-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335323
Hyphenated Format 47335-323

Supplemental Identifiers

RxCUI
1860480 1860485 1861411
UNII
699121PHCA
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 docetaxel (source: ndc)
Generic Name docetaxel (source: ndc)
Application Number NDA022534 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

47335-323-40 1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS

Ingredients (1)

docetaxel anhydrous (20 mg/mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9a0d7b91-4324-4e19-9cd8-eb19266e771a", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["699121PHCA"], "rxcui": ["1860480", "1860485", "1861411"], "spl_set_id": ["c85b2c62-3c33-4cbc-8b79-d5e17851a1b4"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (47335-323-40)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "47335-323-40", "marketing_start_date": "20201126"}], "brand_name": "Docetaxel", "product_id": "47335-323_9a0d7b91-4324-4e19-9cd8-eb19266e771a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "47335-323", "generic_name": "Docetaxel", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "20 mg/mL"}], "application_number": "NDA022534", "marketing_category": "NDA", "marketing_start_date": "20201126", "listing_expiration_date": "20261231"}