25021-652 NDC - ROPIVACAINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 25021-652
  • Proprietary Name: Ropivacaine Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s): 5 mg/mL ROPIVACAINE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Amide Local Anesthetic [EPC]; Amides [CS]; Local Anesthesia [PE]

Labeler Information

Field Name Field Value
Labeler Name: Sagent Pharmaceuticals
Product Type:
FDA Application Number: ANDA090318
Marketing Category: ANDA
Start Marketing Date:9/23/2014
End Marketing Date:5/31/2019

Package Information

No. Package Code Package Description Billing Unit
125021-652-301 VIAL in 1 CARTON (25021-652-30) / 30 mL in 1 VIALML
225021-652-315 VIAL in 1 CARTON (25021-652-31) / 30 mL in 1 VIALML
325021-652-8210 BAG in 1 CARTON (25021-652-82) / 100 mL in 1 BAGML
425021-652-8710 BAG in 1 CARTON (25021-652-87) / 200 mL in 1 BAGML

NDC Record

Field Name Field Value Definition
PRODUCT NDC25021-652The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMERopivacaine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE9/23/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA090318This 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.
LABELER NAMESagent PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC25021-652The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEropivacaine hydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/15/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA206166This 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.
LABELER NAMESagent PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/9/2025

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