lenalidomide

Generic: lenalidomide

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lenalidomide
Generic Name lenalidomide
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lenalidomide 2.5 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4532
Product ID 60505-4532_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211022
Listing Expiration 2026-12-31
Marketing Start 2023-03-09

Pharmacologic Class

Established (EPC)
thalidomide analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054532
Hyphenated Format 60505-4532

Supplemental Identifiers

RxCUI
602910 602912 643712 643720 1242231 1428947
UNII
F0P408N6V4
NUI
N0000184014

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 lenalidomide (source: ndc)
Generic Name lenalidomide (source: ndc)
Application Number ANDA211022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (60505-4532-2)
source: ndc

Packages (1)

60505-4532-2 28 CAPSULE in 1 BOTTLE (60505-4532-2)

Ingredients (1)

lenalidomide (2.5 mg/1)

Linked Drug Pages (1)

Lenalidomide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4", "openfda": {"nui": ["N0000184014"], "unii": ["F0P408N6V4"], "rxcui": ["602910", "602912", "643712", "643720", "1242231", "1428947"], "spl_set_id": ["9943e098-20b0-dbb3-af12-7816eedd3f70"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (60505-4532-2)", "package_ndc": "60505-4532-2", "marketing_start_date": "20230309"}], "brand_name": "Lenalidomide", "product_id": "60505-4532_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "60505-4532", "generic_name": "Lenalidomide", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lenalidomide", "active_ingredients": [{"name": "LENALIDOMIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA211022", "marketing_category": "ANDA", "marketing_start_date": "20230309", "listing_expiration_date": "20261231"}