FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
65145-158
11-digit product format
651450158
Labeler code
65145
Product ID
65145-158_154ea3d0-d53f-4795-a43b-2f0eae9737f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA219050
Marketing category
ANDA
Marketing start
2024-08-15
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
65145-158-01Ephedrine Sulfate1 mL in 1 VIALINJECTION11
65145-158-25Ephedrine Sulfate25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-158-01ML - Milliliter65145-158a68fd74b-1490-4014-b7ef-2ae833ae00bb12025-05-14
65145-158-25ML - Milliliter65145-158ded518bf-2653-47fd-94d2-0c1c9cdd7c0812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-158EPHEDRINE SULFATE INJECTION [CAPLIN STERILES LIMITED]1Current NDC, 2 package rows20240815_154ea3d0-d53f-4795-a43b-2f0eae9737f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN154ea3d0-d53f-4795-a43b-2f0eae9737f61
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD154ea3d0-d53f-4795-a43b-2f0eae9737f61
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY154ea3d0-d53f-4795-a43b-2f0eae9737f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-158-01651450158011 mL in 1 VIAL1 mlHistorical
65145-158-256514501582525 VIAL in 1 CARTON (65145-158-25) / 1 mL in 1 VIAL (65145-158-01) 25 vial2024-08-15NoNoCurrent