EPHEDRINE SULFATE

Product NDC
70518-4433
11-digit product format
705184433
Labeler code
70518
Product ID
70518-4433_3c2fdd1c-235b-9ecf-e063-6394a90a37ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPHEDRINE SULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA216146
Marketing category
ANDA
Marketing start
2025-08-12
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
70518-4433-0EPHEDRINE SULFATE10 in 1 CARTONINJECTION101
70518-4433-1EPHEDRINE SULFATE1 mL in 1 VIALINJECTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN9851cc1c-f267-4e18-b1ad-923fe9cded841
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD9851cc1c-f267-4e18-b1ad-923fe9cded841
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY9851cc1c-f267-4e18-b1ad-923fe9cded841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4433-07051844330010 VIAL in 1 CARTON (70518-4433-0) / 1 mL in 1 VIAL (70518-4433-1) 10 vial2025-08-12NoNoCurrent
70518-4433-1705184433011 mL in 1 VIAL1 mlHistorical