FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
55150-373
11-digit product format
551500373
Labeler code
55150
Product ID
55150-373_2f5f7e49-9355-44e6-99be-ccedfc4942ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA214579
Marketing category
ANDA
Marketing start
2021-06-14
Substance
EPHEDRINE SULFATE
Active strength
50 mg/mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ephedrine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG
Rxcui1116294

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-373-01Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION14
55150-373-25Ephedrine Sulfate25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-373-01ML - Milliliter55150-3731eeed2fe-abf9-40cc-adca-bac4cbe84cd012021-11-09
55150-373-25ML - Milliliter55150-373387d6520-0a4e-4046-a2c3-fb405ace13df12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-373EPHEDRINE SULFATE INJECTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20240510_a5862de7-4118-4bda-8075-0b2524e04585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNa5862de7-4118-4bda-8075-0b2524e045854
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDa5862de7-4118-4bda-8075-0b2524e045854
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYa5862de7-4118-4bda-8075-0b2524e045854
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNd89dd8d5-7698-61db-e053-2a95a90a764b2
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDd89dd8d5-7698-61db-e053-2a95a90a764b2
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYd89dd8d5-7698-61db-e053-2a95a90a764b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-373-01551500373011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
55150-373-255515003732525 VIAL, SINGLE-DOSE in 1 CARTON (55150-373-25) / 1 mL in 1 VIAL, SINGLE-DOSE (55150-373-01) 2021-06-140000-00-00NoNoCurrent