norepinephrine bitartrate in sodium chloride

Generic: norepinephrine bitartrate

Labeler: wg critical care, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate in sodium chloride
Generic Name norepinephrine bitartrate
Labeler wg critical care, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate .128 mg/mL

Manufacturer
WG Critical Care, LLC

Identifiers & Regulatory

Product NDC 44567-643
Product ID 44567-643_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215700
Listing Expiration 2027-12-31
Marketing Start 2022-09-15

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44567643
Hyphenated Format 44567-643

Supplemental Identifiers

RxCUI
2475337 2475340 2619579 2725614
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 in sodium chloride (source: ndc)
Generic Name norepinephrine bitartrate (source: ndc)
Application Number NDA215700 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .128 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01)
source: ndc

Packages (1)

44567-643-10 10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01)

Ingredients (1)

norepinephrine bitartrate (.128 mg/mL)

Linked Drug Pages (1)

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a0cf3162-9ed3-4774-a076-fc8af5bbe3d0", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["2475337", "2475340", "2619579", "2725614"], "spl_set_id": ["ddbef60d-c20a-4ada-928f-e87074c08a54"], "manufacturer_name": ["WG Critical Care, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (44567-643-10)  / 250 mL in 1 BAG (44567-643-01)", "package_ndc": "44567-643-10", "marketing_start_date": "20251001"}], "brand_name": "NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE", "product_id": "44567-643_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "44567-643", "generic_name": "NOREPINEPHRINE BITARTRATE", "labeler_name": "WG Critical Care, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": ".128 mg/mL"}], "application_number": "NDA215700", "marketing_category": "NDA", "marketing_start_date": "20220915", "listing_expiration_date": "20271231"}