NDC 70771-1680 Lenalidomide
Capsule Oral

Product Information

What is NDC 70771-1680?

The NDC code 70771-1680 is assigned by the FDA to the product Lenalidomide which is a human prescription drug product labeled by Zydus Lifesciences Limited. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 70771-1680-1 100 capsule in 1 bottle , 70771-1680-8 21 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70771-1680
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Lenalidomide
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Lenalidomide
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Lenalidomide
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
Dosage FormCapsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Zydus Lifesciences Limited
Labeler Code70771
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		ANDA210154
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-07-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Lenalidomide?


Product Packages

NDC Code 70771-1680-1

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Code 70771-1680-8

Package Description: 21 CAPSULE in 1 BOTTLE

Product Details

What are Lenalidomide Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LENALIDOMIDE 20 mg/1 - A phthalimide and piperidone derivative that has immunomodulatory and antiangiogenic properties. It is used for the treatment of transfusion-dependent anemia in MYELODYSPLASTIC SYNDROMES, and for the treatment of MULTIPLE MYELOMA, and relapsed or refractory MANTLE CELL LYMPHOMA.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Lenalidomide Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Package Label.Principal Display Panel



NDC 70771-1677-7

Lenalidomide Capsules, 5 mg

28 Capsules

Rx only

5 mg label - e67d1c36 75f9 4c68 b728 4f4995ae0d77 01

5 mg label - e67d1c36 75f9 4c68 b728 4f4995ae0d77 01

NDC 70771-1678-7

Lenalidomide Capsules, 10 mg

28 Capsules

Rx only

NDC 70771-1679-8

Lenalidomide Capsules, 15 mg

21 Capsules

Rx only

NDC 70771-1681-8

Lenalidomide Capsules, 25 mg

21 Capsules

Rx only


* Please review the disclaimer below.