Package 83854-013-26
Brand: ropivacaine hydrochloride
Generic: ropivacaine hydrochloridePackage Facts
Identity
Package NDC
83854-013-26
Digits Only
8385401326
Product NDC
83854-013
Description
25 VIAL in 1 CARTON (83854-013-26) / 10 mL in 1 VIAL (83854-013-02)
Marketing
Marketing Status
Brand
ropivacaine hydrochloride
Generic
ropivacaine hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}