ephedrine sulfate

Generic: ephedrine sulfate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 50 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-495
Product ID 68083-495_0b79ab41-7c76-4459-8021-57b4364d7dcd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216146
Listing Expiration 2026-12-31
Marketing Start 2022-02-25

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 68083495
Hyphenated Format 68083-495

Supplemental Identifiers

RxCUI
1116294
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 ANDA216146 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-495-25 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "0b79ab41-7c76-4459-8021-57b4364d7dcd", "openfda": {"unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["4a66e6c1-6d01-46fa-a2da-566fbf6e11a4"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-495-25", "marketing_start_date": "20220225"}], "brand_name": "Ephedrine Sulfate", "product_id": "68083-495_0b79ab41-7c76-4459-8021-57b4364d7dcd", "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": "68083-495", "generic_name": "Ephedrine Sulfate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ephedrine Sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "50 mg/mL"}], "application_number": "ANDA216146", "marketing_category": "ANDA", "marketing_start_date": "20220225", "listing_expiration_date": "20261231"}