docetaxel

Generic: docetaxel

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-678
Product ID 46708-678_682a0b1a-3277-4718-a94e-9645633062bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215744
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708678
Hyphenated Format 46708-678

Supplemental Identifiers

RxCUI
1093280 1860619
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 ANDA215744 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

46708-678-02 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE 46708-678-08 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 mL in 1 VIAL, MULTI-DOSE 46708-678-16 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16) / 16 mL in 1 VIAL, MULTI-DOSE

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": "682a0b1a-3277-4718-a94e-9645633062bf", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["682a0b1a-3277-4718-a94e-9645633062bf"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "46708-678-02", "marketing_start_date": "20230228"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "46708-678-08", "marketing_start_date": "20230228"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "46708-678-16", "marketing_start_date": "20230228"}], "brand_name": "Docetaxel", "product_id": "46708-678_682a0b1a-3277-4718-a94e-9645633062bf", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "46708-678", "generic_name": "Docetaxel", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA215744", "marketing_category": "ANDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}