norepinephrine bitartrate

Generic: norepinephrine bitartrate

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name norepinephrine bitartrate
Generic Name norepinephrine bitartrate
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

norepinephrine bitartrate 16 mg/250mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0116
Product ID 0338-0116_b40627c0-67bf-4740-9d21-83054aa6afd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214313
Listing Expiration 2027-12-31
Marketing Start 2023-11-21

Pharmacologic Class

Classes
catecholamine [epc] catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380116
Hyphenated Format 0338-0116

Supplemental Identifiers

RxCUI
2475337 2475340 2619579
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 NDA214313 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 16 mg/250mL
source: ndc
Packaging
  • 20 BAG in 1 CARTON (0338-0116-20) / 250 mL in 1 BAG
source: ndc

Packages (1)

0338-0116-20 20 BAG in 1 CARTON (0338-0116-20) / 250 mL in 1 BAG

Ingredients (1)

norepinephrine bitartrate (16 mg/250mL)

Linked Drug Pages (1)

NOREPINEPHRINE BITARTRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b40627c0-67bf-4740-9d21-83054aa6afd9", "openfda": {"unii": ["IFY5PE3ZRW"], "rxcui": ["2475337", "2475340", "2619579"], "spl_set_id": ["6363e9b4-29df-4553-904d-a563e5adda6e"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 CARTON (0338-0116-20)  / 250 mL in 1 BAG", "package_ndc": "0338-0116-20", "marketing_start_date": "20231121"}], "brand_name": "NOREPINEPHRINE BITARTRATE", "product_id": "0338-0116_b40627c0-67bf-4740-9d21-83054aa6afd9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Catecholamine [EPC]", "Catecholamines [CS]"], "product_ndc": "0338-0116", "generic_name": "norepinephrine bitartrate", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOREPINEPHRINE BITARTRATE", "active_ingredients": [{"name": "NOREPINEPHRINE BITARTRATE", "strength": "16 mg/250mL"}], "application_number": "NDA214313", "marketing_category": "NDA", "marketing_start_date": "20231121", "listing_expiration_date": "20271231"}