FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
68083-610
11-digit product format
680830610
Labeler code
68083
Product ID
68083-610_f743e5f5-b2bb-424d-887f-9ea5ec06ea92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA218211
Marketing category
ANDA
Marketing start
2025-01-16
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
Rxcui2368456

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
68083-610-10Ephedrine Sulfate10 in 1 CARTONINJECTION103
68083-610-10Ephedrine Sulfate10 mL in 1 VIALINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-610EPHEDRINE SULFATE INJECTION [GLAND PHARMA LIMITED]3Current NDC, 2 package rows20250121_523ec357-7fdb-482d-85f1-acb3b25eb764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2368456ePHEDrine sulfate 50 MG in 10 ML InjectionPSN523ec357-7fdb-482d-85f1-acb3b25eb7643
236845610 ML ephedrine sulfate 5 MG/ML InjectionSCD523ec357-7fdb-482d-85f1-acb3b25eb7643
2368456ephedrine sulfate 50 MG per 10 ML InjectionSY523ec357-7fdb-482d-85f1-acb3b25eb7643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-610-106808306101010 VIAL in 1 CARTON (68083-610-10) / 10 mL in 1 VIAL10 vial2025-01-16NoNoCurrent