ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-671
Product ID 25021-671_2eb59cb8-dab8-43f4-ad73-672446e104ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206166
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021671
Hyphenated Format 25021-671

Supplemental Identifiers

RxCUI
1734347 1734355
UPC
0325021671665
UNII
V910P86109

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 ropivacaine hydrochloride (source: ndc)
Generic Name ropivacaine hydrochloride (source: ndc)
Application Number ANDA206166 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (25021-671-66) / 100 mL in 1 BAG
  • 10 BAG in 1 CARTON (25021-671-67) / 200 mL in 1 BAG
source: ndc

Packages (2)

25021-671-66 10 BAG in 1 CARTON (25021-671-66) / 100 mL in 1 BAG 25021-671-67 10 BAG in 1 CARTON (25021-671-67) / 200 mL in 1 BAG

Ingredients (1)

ropivacaine hydrochloride (2 mg/mL)

Linked Drug Pages (2)

ropivacaine hydrochloride ndc-match (0.9) ropivacaine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION"], "spl_id": "2eb59cb8-dab8-43f4-ad73-672446e104ca", "openfda": {"upc": ["0325021671665"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355"], "spl_set_id": ["9572b3de-684c-4028-a577-5aa69ba6b02d"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (25021-671-66)  / 100 mL in 1 BAG", "package_ndc": "25021-671-66", "marketing_start_date": "20200101"}, {"sample": false, "description": "10 BAG in 1 CARTON (25021-671-67)  / 200 mL in 1 BAG", "package_ndc": "25021-671-67", "marketing_start_date": "20200101"}], "brand_name": "ropivacaine hydrochloride", "product_id": "25021-671_2eb59cb8-dab8-43f4-ad73-672446e104ca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "25021-671", "generic_name": "ropivacaine hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropivacaine hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA206166", "marketing_category": "ANDA", "marketing_start_date": "20200101", "listing_expiration_date": "20261231"}