norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler rising pharma holdings, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-630
Product ID 64980-630_ab8a1422-3508-4480-964c-dbb6681b1428
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218758
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980630
Hyphenated Format 64980-630

Supplemental Identifiers

RxCUI
242969
UPC
0364980630047
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 ANDA218758 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (64980-630-41) / 4 mL in 1 VIAL, SINGLE-DOSE (64980-630-04)
source: ndc

Packages (1)

64980-630-41 10 VIAL, SINGLE-DOSE in 1 CARTON (64980-630-41) / 4 mL in 1 VIAL, SINGLE-DOSE (64980-630-04)

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": "ab8a1422-3508-4480-964c-dbb6681b1428", "openfda": {"upc": ["0364980630047"], "unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["e6669ed6-9ebc-4b2d-9a8c-5e318fbd18b4"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (64980-630-41)  / 4 mL in 1 VIAL, SINGLE-DOSE (64980-630-04)", "package_ndc": "64980-630-41", "marketing_start_date": "20241101"}], "brand_name": "Norepinephrine Bitartrate", "product_id": "64980-630_ab8a1422-3508-4480-964c-dbb6681b1428", "dosage_form": "INJECTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "64980-630", "generic_name": "Norepinephrine Bitartrate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norepinephrine Bitartrate", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA218758", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}