levophed(r) norepinephrine bitartrate

Generic: levophed(r) norepinephrine bitartrate

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levophed(r) norepinephrine bitartrate
Generic Name levophed(r) norepinephrine bitartrate
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1315
Product ID 51662-1315_ba9ee8b4-ee9c-3d1b-e053-2995a90a11de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA007513
Listing Expiration 2026-12-31
Marketing Start 2018-10-18

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621315
Hyphenated Format 51662-1315

Supplemental Identifiers

RxCUI
242969
UNII
IFY5PE3ZRW

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 levophed(r) norepinephrine bitartrate (source: ndc)
Generic Name levophed(r) norepinephrine bitartrate (source: ndc)
Application Number NDA007513 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 4 mL in 1 VIAL, SINGLE-DOSE (51662-1315-1)
  • 10 POUCH in 1 CASE (51662-1315-3) / 1 mL in 1 POUCH (51662-1315-2)
source: ndc

Packages (2)

51662-1315-1 4 mL in 1 VIAL, SINGLE-DOSE (51662-1315-1) 51662-1315-3 10 POUCH in 1 CASE (51662-1315-3) / 1 mL in 1 POUCH (51662-1315-2)

Ingredients (1)

norepinephrine bitartrate (1 mg/mL)

Linked Drug Pages (1)

LEVOPHED(R) NOREPINEPHRINE BITARTRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ba9ee8b4-ee9c-3d1b-e053-2995a90a11de", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["788b6c64-1b6d-0058-e053-2a91aa0aa99c"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "4 mL in 1 VIAL, SINGLE-DOSE (51662-1315-1)", "package_ndc": "51662-1315-1", "marketing_start_date": "20181018"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1315-3)  / 1 mL in 1 POUCH (51662-1315-2)", "package_ndc": "51662-1315-3", "marketing_start_date": "20200926"}], "brand_name": "LEVOPHED(R) NOREPINEPHRINE BITARTRATE", "product_id": "51662-1315_ba9ee8b4-ee9c-3d1b-e053-2995a90a11de", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "51662-1315", "generic_name": "LEVOPHED(R) NOREPINEPHRINE BITARTRATE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOPHED(R) NOREPINEPHRINE BITARTRATE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "NDA007513", "marketing_category": "NDA", "marketing_start_date": "20181018", "listing_expiration_date": "20261231"}