Home NDC 0363-5789 Ephedrine Sulfate
Product NDC 0363-5789
11-digit product format 003635789
Labeler code 0363
Product ID 0363-5789_3dfc301d-e264-adb0-e063-6394a90aed25
Type HUMAN OTC DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-22
Substance EPHEDRINE SULFATE
Active strength 25 mg/1
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ephedrine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPHEDRINE SULFATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U6X61U5ZEG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116194 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-5789-07 Ephedrine Sulfate 5 in 1 CARTON TABLET, FILM COATED 5 4 0363-5789-07 Ephedrine Sulfate 12 in 1 BLISTER PACK TABLET, FILM COATED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5789 EPHEDRINE SULFATE TABLET, FILM COATED [WALGREEN COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20241208_dc0072f9-7111-1af0-e053-2a95a90aed56.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-5789-07 00363578907 5 BLISTER PACK in 1 CARTON (0363-5789-07) / 12 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2022-07-22 0000-00-00 No No Current