ephedrine sulfate

Generic: ephedrine sulfate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 50 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-611
Product ID 84549-611_3a38b027-e8ea-5d08-e063-6294a90a3b49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216129
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

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 84549611
Hyphenated Format 84549-611

Supplemental Identifiers

RxCUI
1116294
UNII
U6X61U5ZEG

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 ANDA216129 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (84549-611-25)
source: ndc

Packages (1)

84549-611-25 1 mL in 1 VIAL, SINGLE-DOSE (84549-611-25)

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": "3a38b027-e8ea-5d08-e063-6294a90a3b49", "openfda": {"unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["3843c820-f54b-5349-e063-6294a90a6b18"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (84549-611-25)", "package_ndc": "84549-611-25", "marketing_start_date": "20250827"}], "brand_name": "Ephedrine sulfate", "product_id": "84549-611_3a38b027-e8ea-5d08-e063-6294a90a3b49", "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": "84549-611", "generic_name": "Ephedrine sulfate", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ephedrine sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "50 mg/mL"}], "application_number": "ANDA216129", "marketing_category": "ANDA", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}