docetaxel

Generic: docetaxel

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler dr. reddy's laboratories inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel 160 mg/8mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-389
Product ID 43598-389_b06584c8-f4fd-46dd-a1f2-0e3672b24938
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204193
Listing Expiration 2026-12-31
Marketing Start 2019-04-22

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598389
Hyphenated Format 43598-389

Supplemental Identifiers

RxCUI
1860480 1860485 1861411
UNII
15H5577CQD

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 ANDA204193 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 160 mg/8mL
source: ndc
Packaging
  • 8 mL in 1 VIAL, GLASS (43598-389-57)
source: ndc

Packages (1)

43598-389-57 8 mL in 1 VIAL, GLASS (43598-389-57)

Ingredients (1)

docetaxel (160 mg/8mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b06584c8-f4fd-46dd-a1f2-0e3672b24938", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1860480", "1860485", "1861411"], "spl_set_id": ["a630937b-8369-74ad-b68a-f940eb16ff0f"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 mL in 1 VIAL, GLASS (43598-389-57)", "package_ndc": "43598-389-57", "marketing_start_date": "20190422"}], "brand_name": "Docetaxel", "product_id": "43598-389_b06584c8-f4fd-46dd-a1f2-0e3672b24938", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "43598-389", "generic_name": "Docetaxel", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "160 mg/8mL"}], "application_number": "ANDA204193", "marketing_category": "ANDA", "marketing_start_date": "20190422", "listing_expiration_date": "20261231"}