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 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-257
Product ID 65219-257_453036d8-bcc1-45a2-a905-edb03a8b743a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209646
Listing Expiration 2026-12-31
Marketing Start 2020-10-31

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 65219257
Hyphenated Format 65219-257

Supplemental Identifiers

RxCUI
1116294
UPC
0365219257004
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 ANDA209646 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 CARTON (65219-257-01) / 1 mL in 1 VIAL, GLASS (65219-257-00)
source: ndc

Packages (1)

65219-257-01 25 VIAL, GLASS in 1 CARTON (65219-257-01) / 1 mL in 1 VIAL, GLASS (65219-257-00)

Ingredients (1)

ephedrine sulfate (50 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": "453036d8-bcc1-45a2-a905-edb03a8b743a", "openfda": {"upc": ["0365219257004"], "unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["5ecd9746-25c7-4bd4-9503-eb97e7db5aa5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (65219-257-01)  / 1 mL in 1 VIAL, GLASS (65219-257-00)", "package_ndc": "65219-257-01", "marketing_start_date": "20201031"}], "brand_name": "Ephedrine Sulfate", "product_id": "65219-257_453036d8-bcc1-45a2-a905-edb03a8b743a", "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": "65219-257", "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": "50 mg/mL"}], "application_number": "ANDA209646", "marketing_category": "ANDA", "marketing_start_date": "20201031", "listing_expiration_date": "20261231"}