norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

norepinephrine bitartrate 1 mg/mL

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-983
Product ID 51991-983_bac5480c-f2a5-4e8a-85f7-a55a059d7c1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214455
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991983
Hyphenated Format 51991-983

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 ANDA214455 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (51991-983-17) / 4 mL in 1 VIAL, SINGLE-DOSE (51991-983-99)
source: ndc

Packages (1)

51991-983-17 10 VIAL, SINGLE-DOSE in 1 CARTON (51991-983-17) / 4 mL in 1 VIAL, SINGLE-DOSE (51991-983-99)

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": "bac5480c-f2a5-4e8a-85f7-a55a059d7c1b", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["109aa5e6-4e42-4131-97b0-f24d3a4cb4e8"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (51991-983-17)  / 4 mL in 1 VIAL, SINGLE-DOSE (51991-983-99)", "package_ndc": "51991-983-17", "marketing_start_date": "20210701"}], "brand_name": "Norepinephrine Bitartrate", "product_id": "51991-983_bac5480c-f2a5-4e8a-85f7-a55a059d7c1b", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "51991-983", "generic_name": "Norepinephrine Bitartrate", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine Bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA214455", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}