paclitaxel

Generic: paclitaxel

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

Drug Facts

Product Profile

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

paclitaxel 6 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-621
Product ID 46708-621_6d04b514-c85c-4db1-919e-21dd98172791
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216874
Listing Expiration 2026-12-31
Marketing Start 2022-10-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708621
Hyphenated Format 46708-621

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 (source: ndc)
Generic Name paclitaxel (source: ndc)
Application Number ANDA216874 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 16.7 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

46708-621-17 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 16.7 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": "6d04b514-c85c-4db1-919e-21dd98172791", "openfda": {"nui": ["N0000175085", "N0000175592"], "unii": ["P88XT4IS4D"], "rxcui": ["312199"], "spl_set_id": ["6d04b514-c85c-4db1-919e-21dd98172791"], "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, MULTI-DOSE in 1 CARTON (46708-621-17)  / 16.7 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "46708-621-17", "marketing_start_date": "20221020"}], "brand_name": "Paclitaxel", "product_id": "46708-621_6d04b514-c85c-4db1-919e-21dd98172791", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "46708-621", "generic_name": "Paclitaxel", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paclitaxel", "active_ingredients": [{"name": "PACLITAXEL", "strength": "6 mg/mL"}], "application_number": "ANDA216874", "marketing_category": "ANDA", "marketing_start_date": "20221020", "listing_expiration_date": "20261231"}