ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ropivacaine hydrochloride 2 mg/mL

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-797
Product ID 70512-797_45729174-5a1c-aa47-e063-6294a90af039
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212808
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512797
Hyphenated Format 70512-797

Supplemental Identifiers

RxCUI
1734347 1734355
UPC
0370512797010
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 ANDA212808 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (70512-797-24) / 100 mL in 1 BAG (70512-797-01)
source: ndc

Packages (1)

70512-797-24 24 BAG in 1 CARTON (70512-797-24) / 100 mL in 1 BAG (70512-797-01)

Ingredients (1)

ropivacaine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

ROPIVACAINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "PERINEURAL"], "spl_id": "45729174-5a1c-aa47-e063-6294a90af039", "openfda": {"upc": ["0370512797010"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355"], "spl_set_id": ["5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a9"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (70512-797-24)  / 100 mL in 1 BAG (70512-797-01)", "package_ndc": "70512-797-24", "marketing_start_date": "20250301"}], "brand_name": "ROPIVACAINE HYDROCHLORIDE", "product_id": "70512-797_45729174-5a1c-aa47-e063-6294a90af039", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70512-797", "generic_name": "ROPIVACAINE HYDROCHLORIDE", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA212808", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}