norepinephrine bitartrate

Generic: norepinephrine bitartrate

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

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler anthea pharma private limited
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Anthea Pharma Private Limited

Identifiers & Regulatory

Product NDC 83854-017
Product ID 83854-017_44791190-e870-ac45-e063-6294a90acaa9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219924
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83854017
Hyphenated Format 83854-017

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 ANDA219924 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83854-017-10) / 4 mL in 1 VIAL (83854-017-01)
source: ndc

Packages (1)

83854-017-10 10 VIAL in 1 CARTON (83854-017-10) / 4 mL in 1 VIAL (83854-017-01)

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": "44791190-e870-ac45-e063-6294a90acaa9", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["52e22892-4fc3-4f53-9f39-0b5c66da3040"], "manufacturer_name": ["Anthea Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83854-017-10)  / 4 mL in 1 VIAL (83854-017-01)", "package_ndc": "83854-017-10", "marketing_start_date": "20251125"}], "brand_name": "NOREPINEPHRINE BITARTRATE", "product_id": "83854-017_44791190-e870-ac45-e063-6294a90acaa9", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "83854-017", "generic_name": "NOREPINEPHRINE BITARTRATE", "labeler_name": "Anthea Pharma Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOREPINEPHRINE BITARTRATE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA219924", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}