NDC 70121-1734 Ropivacaine Hydrochloride
Injection Epidural; Infiltration; Perineural

Product Information

What is NDC 70121-1734?

The NDC code 70121-1734 is assigned by the FDA to the product Ropivacaine Hydrochloride which is a human prescription drug product labeled by Amneal Pharmaceuticals Llc. The product's dosage form is injection and is administered via epidural; infiltration; perineural form. The product is distributed in a single package with assigned NDC code 70121-1734-7 10 pouch in 1 carton / 1 bag in 1 pouch (70121-1734-1) / 100 ml in 1 bag. 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 Code	70121-1734
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.	Ropivacaine Hydrochloride
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.	Ropivacaine Hydrochloride
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 Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)? The translation of the route code submitted by the firm, indicating route of administration.	Epidural - Administration upon or over the dura mater. Infiltration - Administration that results in substances passing into tissue spaces or into cells. Perineural - Administration surrounding a nerve or nerves.
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Amneal Pharmaceuticals Llc
Labeler Code	70121
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.	ANDA216605
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.	03-17-2023
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	70121 - Amneal Pharmaceuticals Llc 70121-1734 - Ropivacaine Hydrochloride 70121-1734-7

Product Packages

NDC Code 70121-1734-7

Package Description: 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH (70121-1734-1) / 100 mL in 1 BAG

Product Details

What are Ropivacaine Hydrochloride 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.

ROPIVACAINE HYDROCHLORIDE 5 mg/mL - An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.

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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