FDA.reportPublic FDA data

Ephedrine sulfate

Product NDC
72603-203
11-digit product format
726030203
Labeler code
72603
Product ID
72603-203_8ba0a259-8d6f-45f8-8af0-35f7bc79105f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NorthStar RxLLC
Application
ANDA216129
Marketing category
ANDA
Marketing start
2024-05-01
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG

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
72603-203-01Ephedrine sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION13
72603-203-25Ephedrine sulfate25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-203-01ML - Milliliter72603-20324b41893-f7b7-4764-87ae-b56bce71e88312024-05-16
72603-203-25ML - Milliliter72603-20380996f25-5876-49b1-ac7a-9a1c117ec1c212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-203EPHEDRINE SULFATE INJECTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20240501_b6fc8311-7853-4666-a1c2-668a04fe2119.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNb6fc8311-7853-4666-a1c2-668a04fe21193
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDb6fc8311-7853-4666-a1c2-668a04fe21193
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYb6fc8311-7853-4666-a1c2-668a04fe21193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-203-01726030203011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
72603-203-257260302032525 VIAL, SINGLE-DOSE in 1 CARTON (72603-203-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72603-203-01) 2024-05-01NoNoCurrent