norepinephrine bitartrate

Generic: norepinephrine bitartrate

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

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9318
Product ID 0143-9318_67c8be26-e727-4eac-b5a5-6c6fda27d2b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203662
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439318
Hyphenated Format 0143-9318

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 ANDA203662 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9318-10) / 4 mL in 1 VIAL (0143-9318-01)
source: ndc

Packages (1)

0143-9318-10 10 VIAL in 1 CARTON (0143-9318-10) / 4 mL in 1 VIAL (0143-9318-01)

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": "67c8be26-e727-4eac-b5a5-6c6fda27d2b9", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["39cda6c6-3857-4028-80cf-aef135f8c7e6"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9318-10)  / 4 mL in 1 VIAL (0143-9318-01)", "package_ndc": "0143-9318-10", "marketing_start_date": "20180801"}], "brand_name": "Norepinephrine Bitartrate", "product_id": "0143-9318_67c8be26-e727-4eac-b5a5-6c6fda27d2b9", "dosage_form": "INJECTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "0143-9318", "generic_name": "Norepinephrine Bitartrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine Bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA203662", "marketing_category": "ANDA", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}