paclitaxel

Generic: paclitaxel

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paclitaxel
Generic Name paclitaxel
Labeler bluepoint laboratories
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

paclitaxel 6 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-516
Product ID 68001-516_395353d9-d8e9-a4df-e063-6394a90ac9a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213434
Listing Expiration 2026-12-31
Marketing Start 2021-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001516
Hyphenated Format 68001-516

Supplemental Identifiers

RxCUI
312199
UPC
0368001516273
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 (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number ANDA213434 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68001-516-27 1 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

paclitaxel (6 mg/mL)

Linked Drug Pages (1)

Paclitaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "395353d9-d8e9-a4df-e063-6394a90ac9a4", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0368001516273"], "unii": ["P88XT4IS4D"], "rxcui": ["312199"], "spl_set_id": ["9e7bc2c2-a369-4c6f-9dd9-ee98ddaae833"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68001-516-27", "marketing_start_date": "20210914"}], "brand_name": "Paclitaxel", "product_id": "68001-516_395353d9-d8e9-a4df-e063-6394a90ac9a4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68001-516", "generic_name": "Paclitaxel", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "6 mg/mL"}], "application_number": "ANDA213434", "marketing_category": "ANDA", "marketing_start_date": "20210914", "listing_expiration_date": "20261231"}