NDC 70114-441 Cimerli

Ranibizumab-eqrn Injection, Solution Intravitreal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
70114-441
Proprietary Name:
Cimerli
Non-Proprietary Name: [1]
Ranibizumab-eqrn
Substance Name: [2]
Ranibizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravitreal - Administration within the vitreous body of the eye.
  • Labeler Name: [5]
    Coherus Biosciences Inc
    Labeler Code:
    70114
    FDA Application Number: [6]
    BLA761165
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-03-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 70114-441-01

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / .05 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 70114-441?

    The NDC code 70114-441 is assigned by the FDA to the product Cimerli which is a human prescription drug product labeled by Coherus Biosciences Inc. The generic name of Cimerli is ranibizumab-eqrn. The product's dosage form is injection, solution and is administered via intravitreal form. The product is distributed in a single package with assigned NDC code 70114-441-01 1 vial, single-dose in 1 carton / .05 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cimerli?

    This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

    What are Cimerli 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.
    • RANIBIZUMAB .5 mg/.05mL - A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

    Which are Cimerli UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Cimerli Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Cimerli?

    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:

    Which are the Pharmacologic Classes for Cimerli?

    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.

    * Please review the disclaimer below.

    Patient Education

    Ranibizumab Injection


    Ranibizumab injection products are used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities). Ranibizumab implant (Susvimo) is also used to treat wet age-related macular degeneration after at least two successful treatments with ranibizumab or a similar medication. Ranibizumab injection products are also used to treat myopic choroidal neovascularization (mCNV; a complication in near-sighted people where new blood vessels can grow in the back of the eye) and to treat macular edema after retinal vein occlusion (an eye disease caused by blockage of blood flow from the eye that leads to blurry vision and vision loss). Ranibizumab injection (Lucentis) is also used to treat diabetic macular edema (an eye disease caused by diabetes that can lead to vision loss) and diabetic retinopathy (damage to the eyes caused by diabetes). Ranibizumab is in a class of medications called vascular endothelial growth factor A (VEGF-A) antagonists. It works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".