ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: anthea pharma private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler anthea pharma private limited
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Anthea Pharma Private Limited

Identifiers & Regulatory

Product NDC 83854-013
Product ID 83854-013_428b4218-2c8d-6dee-e063-6394a90a1b89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219883
Listing Expiration 2026-12-31
Marketing Start 2025-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83854013
Hyphenated Format 83854-013

Supplemental Identifiers

RxCUI
1734084 1734207 1734475
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 ANDA219883 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83854-013-10) / 20 mL in 1 VIAL (83854-013-01)
  • 25 VIAL in 1 CARTON (83854-013-25) / 20 mL in 1 VIAL (83854-013-01)
  • 25 VIAL in 1 CARTON (83854-013-26) / 10 mL in 1 VIAL (83854-013-02)
source: ndc

Packages (3)

83854-013-10 10 VIAL in 1 CARTON (83854-013-10) / 20 mL in 1 VIAL (83854-013-01) 83854-013-25 25 VIAL in 1 CARTON (83854-013-25) / 20 mL in 1 VIAL (83854-013-01) 83854-013-26 25 VIAL in 1 CARTON (83854-013-26) / 10 mL in 1 VIAL (83854-013-02)

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"], "spl_id": "428b4218-2c8d-6dee-e063-6394a90a1b89", "openfda": {"unii": ["V910P86109"], "rxcui": ["1734084", "1734207", "1734475"], "spl_set_id": ["f2b54355-a596-4f97-aeaa-d93e3984c42d"], "manufacturer_name": ["Anthea Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83854-013-10)  / 20 mL in 1 VIAL (83854-013-01)", "package_ndc": "83854-013-10", "marketing_start_date": "20250321"}, {"sample": false, "description": "25 VIAL in 1 CARTON (83854-013-25)  / 20 mL in 1 VIAL (83854-013-01)", "package_ndc": "83854-013-25", "marketing_start_date": "20250321"}, {"sample": false, "description": "25 VIAL in 1 CARTON (83854-013-26)  / 10 mL in 1 VIAL (83854-013-02)", "package_ndc": "83854-013-26", "marketing_start_date": "20251008"}], "brand_name": "ROPIVACAINE HYDROCHLORIDE", "product_id": "83854-013_428b4218-2c8d-6dee-e063-6394a90a1b89", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "83854-013", "generic_name": "ROPIVACAINE HYDROCHLORIDE", "labeler_name": "Anthea Pharma Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA219883", "marketing_category": "ANDA", "marketing_start_date": "20250321", "listing_expiration_date": "20261231"}