FDA.reportPublic FDA data

Ephedrine sulfate

Product NDC
43598-725
11-digit product format
435980725
Labeler code
43598
Product ID
43598-725_e4f1e75a-e315-00f1-a044-13b6d2dcbca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA212649
Marketing category
ANDA
Marketing start
2021-10-04
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
43598-725-11Ephedrine sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION17
43598-725-25Ephedrine sulfate25 in 1 CARTONINJECTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-725-11ML - Milliliter43598-7254f582f92-f9b0-495d-a457-7b833c7d8c0312021-11-09
43598-725-25ML - Milliliter43598-7255581a80b-7793-4d9c-a78a-893e29079e4412021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-725EPHEDRINE SULFATE INJECTION [DR. REDDY'S LABORATORIES, INC.]7Current NDC, Legacy NDC, 2 package rows20240802_1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e967
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e967
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-725-11435980725111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
43598-725-254359807252525 VIAL, SINGLE-DOSE in 1 CARTON (43598-725-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-725-11) 2021-10-040000-00-00NoNoCurrent