norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-133
Product ID 65145-133_9640013b-5019-476a-a35a-2a08084a2a3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217575
Listing Expiration 2026-12-31
Marketing Start 2024-09-28

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145133
Hyphenated Format 65145-133

Supplemental Identifiers

RxCUI
242969
UPC
0365145133014
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 ANDA217575 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01)
source: ndc

Packages (1)

65145-133-10 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01)

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": "9640013b-5019-476a-a35a-2a08084a2a3b", "openfda": {"upc": ["0365145133014"], "unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["2ffda6e7-d45d-4af3-a3b1-250a4c95e736"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10)  / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01)", "package_ndc": "65145-133-10", "marketing_start_date": "20240928"}], "brand_name": "NOREPINEPHRINE BITARTRATE", "product_id": "65145-133_9640013b-5019-476a-a35a-2a08084a2a3b", "dosage_form": "INJECTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "65145-133", "generic_name": "norepinephrine bitartrate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOREPINEPHRINE BITARTRATE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA217575", "marketing_category": "ANDA", "marketing_start_date": "20240928", "listing_expiration_date": "20261231"}