norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: avenacy, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler avenacy, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-307
Product ID 83634-307_2f29a14c-9f95-4661-aeef-aa0274023ba4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219924
Listing Expiration 2026-12-31
Marketing Start 2026-02-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634307
Hyphenated Format 83634-307

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, SINGLE-DOSE in 1 CARTON (83634-307-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-307-41)
source: ndc

Packages (1)

83634-307-04 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-307-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-307-41)

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": "2f29a14c-9f95-4661-aeef-aa0274023ba4", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["dd4b7827-2fe9-4427-a40a-60f275611bf4"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-307-04)  / 4 mL in 1 VIAL, SINGLE-DOSE (83634-307-41)", "package_ndc": "83634-307-04", "marketing_start_date": "20260201"}], "brand_name": "norepinephrine bitartrate", "product_id": "83634-307_2f29a14c-9f95-4661-aeef-aa0274023ba4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "83634-307", "generic_name": "norepinephrine bitartrate", "labeler_name": "Avenacy, LLC", "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": "20260201", "listing_expiration_date": "20261231"}