norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-437
Product ID 68083-437_5551d4eb-6e6f-4229-bd11-1442f685abe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214323
Listing Expiration 2026-12-31
Marketing Start 2021-05-12

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083437
Hyphenated Format 68083-437

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 ANDA214323 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-437-10) / 4 mL in 1 VIAL, SINGLE-DOSE (68083-437-01)
source: ndc

Packages (1)

68083-437-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-437-10) / 4 mL in 1 VIAL, SINGLE-DOSE (68083-437-01)

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": "5551d4eb-6e6f-4229-bd11-1442f685abe1", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["dec04acd-8e66-43c7-80b0-468802eba093"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-437-10)  / 4 mL in 1 VIAL, SINGLE-DOSE (68083-437-01)", "package_ndc": "68083-437-10", "marketing_start_date": "20210512"}], "brand_name": "Norepinephrine bitartrate", "product_id": "68083-437_5551d4eb-6e6f-4229-bd11-1442f685abe1", "dosage_form": "INJECTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "68083-437", "generic_name": "Norepinephrine bitartrate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA214323", "marketing_category": "ANDA", "marketing_start_date": "20210512", "listing_expiration_date": "20261231"}