ephedrine sulfate

Generic: ephedrine sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-546
Product ID 65219-546_de95d79e-ae15-4056-a4e5-ac3380768cdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218271
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] increased norepinephrine activity [pe] norepinephrine releasing agent [epc] alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219546
Hyphenated Format 65219-546

Supplemental Identifiers

RxCUI
2586841 2631017
UNII
U6X61U5ZEG

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 ephedrine sulfate (source: ndc)
Generic Name ephedrine sulfate (source: ndc)
Application Number ANDA218271 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01)
source: ndc

Packages (1)

65219-546-05 10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01)

Ingredients (1)

ephedrine sulfate (5 mg/mL)

Linked Drug Pages (1)

ephedrine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "de95d79e-ae15-4056-a4e5-ac3380768cdb", "openfda": {"unii": ["U6X61U5ZEG"], "rxcui": ["2586841", "2631017"], "spl_set_id": ["c021fe1b-3ac3-4577-b780-f6a3070908a1"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05)  / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01)", "package_ndc": "65219-546-05", "marketing_start_date": "20250707"}], "brand_name": "ephedrine sulfate", "product_id": "65219-546_de95d79e-ae15-4056-a4e5-ac3380768cdb", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Releasing Agent [EPC]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "65219-546", "generic_name": "ephedrine sulfate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ephedrine sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "5 mg/mL"}], "application_number": "ANDA218271", "marketing_category": "ANDA", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}