lenalidomide

Generic: lenalidomide

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

Drug Facts

Product Profile

Brand Name lenalidomide
Generic Name lenalidomide
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lenalidomide 5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1936
Product ID 0378-1936_c46c02e1-8159-4ab8-b6ab-3da52e4eb13e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213912
Listing Expiration 2026-12-31
Marketing Start 2022-09-06

Pharmacologic Class

Established (EPC)
thalidomide analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781936
Hyphenated Format 0378-1936

Supplemental Identifiers

RxCUI
602910 602912 643712 643720 1242231 1428947
UPC
0303781935289
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 ANDA213912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
source: ndc

Packages (2)

0378-1936-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01) 0378-1936-28 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)

Ingredients (1)

lenalidomide (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": "c46c02e1-8159-4ab8-b6ab-3da52e4eb13e", "openfda": {"nui": ["N0000184014"], "upc": ["0303781935289"], "unii": ["F0P408N6V4"], "rxcui": ["602910", "602912", "643712", "643720", "1242231", "1428947"], "spl_set_id": ["76f6c1e7-985b-43d9-892c-849df50ae80e"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)", "package_ndc": "0378-1936-01", "marketing_start_date": "20220906"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)", "package_ndc": "0378-1936-28", "marketing_start_date": "20220906"}], "brand_name": "Lenalidomide", "product_id": "0378-1936_c46c02e1-8159-4ab8-b6ab-3da52e4eb13e", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "0378-1936", "generic_name": "Lenalidomide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lenalidomide", "active_ingredients": [{"name": "LENALIDOMIDE", "strength": "5 mg/1"}], "application_number": "ANDA213912", "marketing_category": "ANDA", "marketing_start_date": "20220906", "listing_expiration_date": "20261231"}