ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

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

Drug Facts

Product Profile

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

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1733
Product ID 70121-1733_aa7176ac-f262-4470-a4de-60e288c05ac3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216605
Listing Expiration 2026-12-31
Marketing Start 2023-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211733
Hyphenated Format 70121-1733

Supplemental Identifiers

RxCUI
1734347 1734355 1734479 1734481
UPC
0370121173533 0370121173434 0370121173335 0370121173311 0370121173410 0370121173519 0370121173397 0370121173298 0370121173212
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 ANDA216605 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (70121-1733-3) / 1 BAG in 1 POUCH / 200 mL in 1 BAG
  • 24 POUCH in 1 CARTON (70121-1733-9) / 1 BAG in 1 POUCH / 200 mL in 1 BAG
source: ndc

Packages (2)

70121-1733-3 12 POUCH in 1 CARTON (70121-1733-3) / 1 BAG in 1 POUCH / 200 mL in 1 BAG 70121-1733-9 24 POUCH in 1 CARTON (70121-1733-9) / 1 BAG in 1 POUCH / 200 mL in 1 BAG

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": "aa7176ac-f262-4470-a4de-60e288c05ac3", "openfda": {"upc": ["0370121173533", "0370121173434", "0370121173335", "0370121173311", "0370121173410", "0370121173519", "0370121173397", "0370121173298", "0370121173212"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355", "1734479", "1734481"], "spl_set_id": ["da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (70121-1733-3)  / 1 BAG in 1 POUCH / 200 mL in 1 BAG", "package_ndc": "70121-1733-3", "marketing_start_date": "20231204"}, {"sample": false, "description": "24 POUCH in 1 CARTON (70121-1733-9)  / 1 BAG in 1 POUCH / 200 mL in 1 BAG", "package_ndc": "70121-1733-9", "marketing_start_date": "20230317"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "70121-1733_aa7176ac-f262-4470-a4de-60e288c05ac3", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70121-1733", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA216605", "marketing_category": "ANDA", "marketing_start_date": "20230317", "listing_expiration_date": "20261231"}