ephedrine sulfate

Generic: ephedrine sulfate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 50 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-158
Product ID 65145-158_154ea3d0-d53f-4795-a43b-2f0eae9737f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219050
Listing Expiration 2026-12-31
Marketing Start 2024-08-15

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 65145158
Hyphenated Format 65145-158

Supplemental Identifiers

RxCUI
1116294
UPC
0365145158017 0365145158253
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 ANDA219050 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (65145-158-25) / 1 mL in 1 VIAL (65145-158-01)
source: ndc

Packages (1)

65145-158-25 25 VIAL in 1 CARTON (65145-158-25) / 1 mL in 1 VIAL (65145-158-01)

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": "154ea3d0-d53f-4795-a43b-2f0eae9737f6", "openfda": {"upc": ["0365145158017", "0365145158253"], "unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["154ea3d0-d53f-4795-a43b-2f0eae9737f6"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (65145-158-25)  / 1 mL in 1 VIAL (65145-158-01)", "package_ndc": "65145-158-25", "marketing_start_date": "20240815"}], "brand_name": "Ephedrine Sulfate", "product_id": "65145-158_154ea3d0-d53f-4795-a43b-2f0eae9737f6", "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": "65145-158", "generic_name": "Ephedrine Sulfate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ephedrine Sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "50 mg/mL"}], "application_number": "ANDA219050", "marketing_category": "ANDA", "marketing_start_date": "20240815", "listing_expiration_date": "20261231"}