ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler northstar rx llc
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-216
Product ID 72603-216_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212808
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603216
Hyphenated Format 72603-216

Supplemental Identifiers

RxCUI
1734084 1734207 1734475 1734483
UPC
0372603219012 0372603216257 0372603219258 0372603217018 0372603218015 0372603217254 0372603218251
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
  • 25 VIAL in 1 CARTON (72603-216-25) / 20 mL in 1 VIAL (72603-216-01)
source: ndc

Packages (1)

72603-216-25 25 VIAL in 1 CARTON (72603-216-25) / 20 mL in 1 VIAL (72603-216-01)

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": "61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1", "openfda": {"upc": ["0372603219012", "0372603216257", "0372603219258", "0372603217018", "0372603218015", "0372603217254", "0372603218251"], "unii": ["V910P86109"], "rxcui": ["1734084", "1734207", "1734475", "1734483"], "spl_set_id": ["61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (72603-216-25)  / 20 mL in 1 VIAL (72603-216-01)", "package_ndc": "72603-216-25", "marketing_start_date": "20240301"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "72603-216_61896fe6-4a5a-4e0f-bfc2-44265bc1f2c1", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "72603-216", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "NorthStar Rx 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": "20240301", "listing_expiration_date": "20261231"}