FDA.reportPublic FDA data

Ephedrine Sulfate

Product NDC
71872-7336
11-digit product format
718727336
Labeler code
71872
Product ID
71872-7336_29797b79-3cd4-ed98-e063-6294a90aaa1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA215825
Marketing category
ANDA
Marketing start
2022-04-21
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
71872-7336-1Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION12
71872-7336-1Ephedrine Sulfate1 in 1 BAGINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7336EPHEDRINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, 2 package rows20241219_296b3b1f-a151-fd40-e063-6294a90a4f4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN296b3b1f-a151-fd40-e063-6294a90a4f4e2
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD296b3b1f-a151-fd40-e063-6294a90a4f4e2
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY296b3b1f-a151-fd40-e063-6294a90a4f4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7336-1718727336011 VIAL, SINGLE-DOSE in 1 BAG (71872-7336-1) / 1 mL in 1 VIAL, SINGLE-DOSE2024-12-06NoNoCurrent