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 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6236
Product ID 0641-6236_2d36e5ea-35a6-467b-860c-2b1b136bb0f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217721
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

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 06416236
Hyphenated Format 0641-6236

Supplemental Identifiers

RxCUI
2586841
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 ANDA217721 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10) / 5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

0641-6236-10 10 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10) / 5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

ephedrine sulfate (5 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": "2d36e5ea-35a6-467b-860c-2b1b136bb0f8", "openfda": {"unii": ["U6X61U5ZEG"], "rxcui": ["2586841"], "spl_set_id": ["24787cb1-23e8-4baa-9838-a31a466b8c79"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0641-6236-10", "marketing_start_date": "20241220"}], "brand_name": "Ephedrine Sulfate", "product_id": "0641-6236_2d36e5ea-35a6-467b-860c-2b1b136bb0f8", "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": "0641-6236", "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": "5 mg/mL"}], "application_number": "ANDA217721", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}