lenalidomide

Generic: lenalidomide

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lenalidomide
Generic Name lenalidomide
Labeler cipla usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lenalidomide 5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-381
Product ID 69097-381_6b77715c-f6f7-408c-8efd-bfdd3125aec4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210435
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 69097381
Hyphenated Format 69097-381

Supplemental Identifiers

RxCUI
602910 602912 643712 643720 1428947
UPC
0369097383817 0369097382735 0369097385811 0369097384814
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 ANDA210435 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
source: ndc

Packages (1)

69097-381-73 28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)

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": "6b77715c-f6f7-408c-8efd-bfdd3125aec4", "openfda": {"nui": ["N0000184014"], "upc": ["0369097383817", "0369097382735", "0369097385811", "0369097384814"], "unii": ["F0P408N6V4"], "rxcui": ["602910", "602912", "643712", "643720", "1428947"], "spl_set_id": ["ba2a07fd-ca60-40bc-b79b-9caf81900fa3"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)", "package_ndc": "69097-381-73", "marketing_start_date": "20220906"}], "brand_name": "lenalidomide", "product_id": "69097-381_6b77715c-f6f7-408c-8efd-bfdd3125aec4", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "69097-381", "generic_name": "lenalidomide", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lenalidomide", "active_ingredients": [{"name": "LENALIDOMIDE", "strength": "5 mg/1"}], "application_number": "ANDA210435", "marketing_category": "ANDA", "marketing_start_date": "20220906", "listing_expiration_date": "20261231"}