norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-852
Product ID 67457-852_af3a6bd3-bbc9-43a9-a277-b55ae59d5097
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211242
Listing Expiration 2026-12-31
Marketing Start 2018-10-15

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457852
Hyphenated Format 67457-852

Supplemental Identifiers

RxCUI
242969
UNII
IFY5PE3ZRW

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 norepinephrine bitartrate (source: ndc)
Generic Name norepinephrine bitartrate (source: ndc)
Application Number ANDA211242 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00)
source: ndc

Packages (1)

67457-852-04 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00)

Ingredients (1)

norepinephrine bitartrate (1 mg/mL)

Linked Drug Pages (1)

Norepinephrine bitartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "af3a6bd3-bbc9-43a9-a277-b55ae59d5097", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["d3ea12e0-88cc-49b0-b06e-5199ecd6ca69"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04)  / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00)", "package_ndc": "67457-852-04", "marketing_start_date": "20181015"}], "brand_name": "Norepinephrine bitartrate", "product_id": "67457-852_af3a6bd3-bbc9-43a9-a277-b55ae59d5097", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "67457-852", "generic_name": "Norepinephrine bitartrate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA211242", "marketing_category": "ANDA", "marketing_start_date": "20181015", "listing_expiration_date": "20261231"}