FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
25021-836
11-digit product format
250210836
Labeler code
25021
Product ID
25021-836_0cced8a7-58b3-43e5-afca-2d6d3ed4c017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214528
Marketing category
ANDA
Marketing start
2023-04-15
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
25021-836-01Ephedrine Sulfate1 mL in 1 VIALINJECTION, SOLUTION16
25021-836-01Ephedrine Sulfate25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-836-01ML - Milliliter25021-8369199c292-caab-45b5-9f67-954237d8012e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-836EPHEDRINE SULFATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6Current NDC, 2 package rows20230415_614e6649-a0e1-4428-855b-363abdb126d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN614e6649-a0e1-4428-855b-363abdb126d86
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD614e6649-a0e1-4428-855b-363abdb126d86
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY614e6649-a0e1-4428-855b-363abdb126d86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-836-012502108360125 VIAL in 1 CARTON (25021-836-01) / 1 mL in 1 VIAL25 vial2023-04-15NoNoCurrent