paclitaxel paclitaxel

Generic: paclitaxel

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel paclitaxel
Generic Name paclitaxel
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 6 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-180
Product ID 68083-180_aeff20f1-c4e7-46c6-a6cb-f0aab334571b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207326
Listing Expiration 2026-12-31
Marketing Start 2016-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083180
Hyphenated Format 68083-180

Supplemental Identifiers

RxCUI
312199
UNII
P88XT4IS4D
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 paclitaxel paclitaxel (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number ANDA207326 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-180-01) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-180-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-180-01) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

paclitaxel (6 mg/mL)

Linked Drug Pages (1)

PACLITAXEL PACLITAXEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "aeff20f1-c4e7-46c6-a6cb-f0aab334571b", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["312199"], "spl_set_id": ["fec9ddee-53a9-4a61-ad0a-be6b604de084"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-180-01)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-180-01", "marketing_start_date": "20160930"}], "brand_name": "PACLITAXEL PACLITAXEL", "product_id": "68083-180_aeff20f1-c4e7-46c6-a6cb-f0aab334571b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68083-180", "generic_name": "paclitaxel", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PACLITAXEL", "brand_name_suffix": "PACLITAXEL", "active_ingredients": [{"name": "PACLITAXEL", "strength": "6 mg/mL"}], "application_number": "ANDA207326", "marketing_category": "ANDA", "marketing_start_date": "20160930", "listing_expiration_date": "20261231"}