ephedrine sulfate

Generic: ephedrine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6238
Product ID 0641-6238_355370f0-4f22-42cf-92c4-fda0763ccc2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214334
Listing Expiration 2026-12-31
Marketing Start 2020-12-15

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 06416238
Hyphenated Format 0641-6238

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 ANDA214334 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01)
source: ndc

Packages (1)

0641-6238-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01)

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": "355370f0-4f22-42cf-92c4-fda0763ccc2e", "openfda": {"unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["794cb942-04e3-4472-8eb8-92613329e4d5"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01)", "package_ndc": "0641-6238-25", "marketing_start_date": "20201215"}], "brand_name": "Ephedrine Sulfate", "product_id": "0641-6238_355370f0-4f22-42cf-92c4-fda0763ccc2e", "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": "0641-6238", "generic_name": "Ephedrine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ephedrine Sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "50 mg/mL"}], "application_number": "ANDA214334", "marketing_category": "ANDA", "marketing_start_date": "20201215", "listing_expiration_date": "20261231"}