ephedrine sulfate

Generic: ephedrine sulfate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ephedrine sulfate
Generic Name ephedrine sulfate
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ephedrine sulfate 50 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1637
Product ID 70121-1637_15f1d276-c5fd-4ad5-8b02-a48a6843eb2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212932
Listing Expiration 2026-12-31
Marketing Start 2019-10-23

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 701211637
Hyphenated Format 70121-1637

Supplemental Identifiers

RxCUI
1116294
UPC
0370121163756
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 ANDA212932 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)
source: ndc

Packages (2)

70121-1637-5 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) 70121-1637-7 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)

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": "15f1d276-c5fd-4ad5-8b02-a48a6843eb2e", "openfda": {"upc": ["0370121163756"], "unii": ["U6X61U5ZEG"], "rxcui": ["1116294"], "spl_set_id": ["765ed48b-b381-418a-9847-068f7f4cc838"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5)  / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)", "package_ndc": "70121-1637-5", "marketing_start_date": "20191023"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7)  / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)", "package_ndc": "70121-1637-7", "marketing_start_date": "20191023"}], "brand_name": "Ephedrine Sulfate", "product_id": "70121-1637_15f1d276-c5fd-4ad5-8b02-a48a6843eb2e", "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": "70121-1637", "generic_name": "Ephedrine Sulfate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ephedrine Sulfate", "active_ingredients": [{"name": "EPHEDRINE SULFATE", "strength": "50 mg/mL"}], "application_number": "ANDA212932", "marketing_category": "ANDA", "marketing_start_date": "20191023", "listing_expiration_date": "20261231"}