norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-439
Product ID 71288-439_48ca273a-3c9d-4466-8804-a0a24790d379
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040455
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288439
Hyphenated Format 71288-439

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 ANDA040455 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (71288-439-05) / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04)
source: ndc

Packages (1)

71288-439-05 10 VIAL, SINGLE-USE in 1 CARTON (71288-439-05) / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04)

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": "48ca273a-3c9d-4466-8804-a0a24790d379", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["53578ac5-b510-4698-a097-f785bfea9fc0"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (71288-439-05)  / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04)", "package_ndc": "71288-439-05", "marketing_start_date": "20241201"}], "brand_name": "Norepinephrine Bitartrate", "product_id": "71288-439_48ca273a-3c9d-4466-8804-a0a24790d379", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "71288-439", "generic_name": "Norepinephrine Bitartrate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine Bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA040455", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}