FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
72572-150
11-digit product format
725720150
Labeler code
72572
Product ID
72572-150_5cb4b67b-3d20-45de-9d29-d70cb4da1b74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA209784
Marketing category
ANDA
Marketing start
2021-03-29
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
72572-150-01Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION14
72572-150-10Ephedrine Sulfate10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-150-01ML - Milliliter72572-1501ea54f6b-7bae-4383-898b-2e0bdc7dd67312021-03-02
72572-150-10ML - Milliliter72572-1501b11e886-1006-4607-8c5b-350aae61fbf312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-150EPHEDRINE SULFATE INJECTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20230510_8f6c6588-77b6-40c7-a897-52e881854d7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN8f6c6588-77b6-40c7-a897-52e881854d7f4
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD8f6c6588-77b6-40c7-a897-52e881854d7f4
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY8f6c6588-77b6-40c7-a897-52e881854d7f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-150-01725720150011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
72572-150-107257201501010 VIAL, SINGLE-DOSE in 1 CARTON (72572-150-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-150-01) 2021-03-290000-00-00NoNoCurrent