docetaxel anhydrous

Generic: docetaxel anhydrous

Labeler: meitheal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel anhydrous
Generic Name docetaxel anhydrous
Labeler meitheal pharmaceuticals inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-144
Product ID 71288-144_77b41d41-9975-428a-865a-1593d21b3d99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209634
Listing Expiration 2026-12-31
Marketing Start 2018-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288144
Hyphenated Format 71288-144

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 anhydrous (source: ndc)
Generic Name docetaxel anhydrous (source: ndc)
Application Number ANDA209634 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

71288-144-08 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE 71288-144-16 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

docetaxel anhydrous (10 mg/mL)

Linked Drug Pages (1)

Docetaxel anhydrous ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77b41d41-9975-428a-865a-1593d21b3d99", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["699121PHCA"], "rxcui": ["1093280"], "spl_set_id": ["9fb533da-a7ba-4c2b-8e4f-8e336ba55d12"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08)  / 8 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-144-08", "marketing_start_date": "20180824"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16)  / 16 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-144-16", "marketing_start_date": "20180824"}], "brand_name": "Docetaxel anhydrous", "product_id": "71288-144_77b41d41-9975-428a-865a-1593d21b3d99", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "71288-144", "generic_name": "Docetaxel anhydrous", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel anhydrous", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA209634", "marketing_category": "ANDA", "marketing_start_date": "20180824", "listing_expiration_date": "20261231"}