norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 1 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-615
Product ID 47335-615_4bb42f07-a41e-42f3-92e7-dab665584f84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211980
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335615
Hyphenated Format 47335-615

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 ANDA211980 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (47335-615-44) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

47335-615-44 10 VIAL, SINGLE-DOSE in 1 CARTON (47335-615-44) / 4 mL in 1 VIAL, SINGLE-DOSE

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": "4bb42f07-a41e-42f3-92e7-dab665584f84", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["242969"], "spl_set_id": ["4bb42f07-a41e-42f3-92e7-dab665584f84"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (47335-615-44)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-615-44", "marketing_start_date": "20210701"}], "brand_name": "NOREPINEPHRINE BITARTRATE", "product_id": "47335-615_4bb42f07-a41e-42f3-92e7-dab665584f84", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "47335-615", "generic_name": "NOREPINEPHRINE BITARTRATE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOREPINEPHRINE BITARTRATE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA211980", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}