FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
0641-6236
11-digit product format
006416236
Labeler code
0641
Product ID
0641-6236_2d36e5ea-35a6-467b-860c-2b1b136bb0f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA217721
Marketing category
ANDA
Marketing start
2024-12-20
Substance
EPHEDRINE SULFATE
Active strength
5 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 SULFATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG
Rxcui2586841

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
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6236-10Ephedrine Sulfate10 in 1 CARTONINJECTION104
0641-6236-10Ephedrine Sulfate5 mL in 1 SYRINGE, PLASTICINJECTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6236EPHEDRINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20241222_24787cb1-23e8-4baa-9838-a31a466b8c79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586841ePHEDrine sulfate 25 MG in 5 ML Prefilled SyringePSN24787cb1-23e8-4baa-9838-a31a466b8c794
25868415 ML ephedrine sulfate 5 MG/ML Prefilled SyringeSCD24787cb1-23e8-4baa-9838-a31a466b8c794
2586841ephedrine sulfate 25 MG (equivalent to 19 MG ephedrine) per 5 ML Prefilled SyringeSY24787cb1-23e8-4baa-9838-a31a466b8c794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0641-6236-100064162361010 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10) / 5 mL in 1 SYRINGE, PLASTIC2024-12-20NoNoCurrent