docetaxel

Generic: docetaxel anhydrous

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

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel anhydrous
Labeler sagent pharmaceuticals
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-254
Product ID 25021-254_841e3024-e160-4c4b-93d3-1e79d628d95b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213510
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021254
Hyphenated Format 25021-254

Supplemental Identifiers

RxCUI
1093280
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 anhydrous (source: ndc)
Application Number ANDA213510 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL
source: ndc

Packages (2)

25021-254-08 1 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL 25021-254-16 1 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL

Ingredients (1)

docetaxel anhydrous (10 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": "841e3024-e160-4c4b-93d3-1e79d628d95b", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["699121PHCA"], "rxcui": ["1093280"], "spl_set_id": ["6b227144-c844-4549-960c-cc3ac5c13b2b"], "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 (25021-254-08)  / 8 mL in 1 VIAL", "package_ndc": "25021-254-08", "marketing_start_date": "20230801"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-254-16)  / 16 mL in 1 VIAL", "package_ndc": "25021-254-16", "marketing_start_date": "20230801"}], "brand_name": "Docetaxel", "product_id": "25021-254_841e3024-e160-4c4b-93d3-1e79d628d95b", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "25021-254", "generic_name": "Docetaxel Anhydrous", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA213510", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}