docetaxel

Generic: docetaxel

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

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler armas pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel 160 mg/8mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-216
Product ID 72485-216_10308491-d534-4e9f-9fcc-8d8a3eda213d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210327
Listing Expiration 2026-12-31
Marketing Start 2020-01-15

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485216
Hyphenated Format 72485-216

Supplemental Identifiers

RxCUI
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 ANDA210327 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 160 mg/8mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (72485-216-08) / 8 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

72485-216-08 1 VIAL, SINGLE-USE in 1 CARTON (72485-216-08) / 8 mL in 1 VIAL, SINGLE-USE

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": "10308491-d534-4e9f-9fcc-8d8a3eda213d", "openfda": {"unii": ["15H5577CQD"], "rxcui": ["1861411"], "spl_set_id": ["0dd863ec-f9dc-456c-9df5-4e9210d6cbb0"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (72485-216-08)  / 8 mL in 1 VIAL, SINGLE-USE", "package_ndc": "72485-216-08", "marketing_start_date": "20200115"}], "brand_name": "Docetaxel", "product_id": "72485-216_10308491-d534-4e9f-9fcc-8d8a3eda213d", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "72485-216", "generic_name": "Docetaxel", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL", "strength": "160 mg/8mL"}], "application_number": "ANDA210327", "marketing_category": "ANDA", "marketing_start_date": "20200115", "listing_expiration_date": "20261231"}