FDA.reportPublic FDA data

Ephedrine sulfate

Product NDC
70756-611
11-digit product format
707560611
Labeler code
70756
Product ID
70756-611_abbedc8b-c9b5-4049-a31b-dbffb73c6556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Lifestar Pharma LLC
Application
ANDA216129
Marketing category
ANDA
Marketing start
2022-04-15
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
70756-611-25Ephedrine sulfate25 in 1 CARTONINJECTION254
70756-611-82Ephedrine sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-611-25ML - Milliliter70756-61110064b4f-2431-4ecd-802f-33df39b91fea12022-08-04
70756-611-82ML - Milliliter70756-6118005d5a4-51f9-4941-88d4-6e9d624f2da812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-611EPHEDRINE SULFATE INJECTION [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20220424_49fc67d1-3b30-456b-951c-ca7f703432ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN49fc67d1-3b30-456b-951c-ca7f703432ab4
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD49fc67d1-3b30-456b-951c-ca7f703432ab4
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY49fc67d1-3b30-456b-951c-ca7f703432ab4
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN3843c820-f54b-5349-e063-6294a90a6b183
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD3843c820-f54b-5349-e063-6294a90a6b183
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY3843c820-f54b-5349-e063-6294a90a6b183
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN08f5ec19-7b53-681b-e063-6294a90acc861
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD08f5ec19-7b53-681b-e063-6294a90acc861
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY08f5ec19-7b53-681b-e063-6294a90acc861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-611-257075606112525 VIAL, SINGLE-DOSE in 1 CARTON (70756-611-25) / 1 mL in 1 VIAL, SINGLE-DOSE (70756-611-82) 2022-04-150000-00-00NoNoCurrent
70756-611-82707560611821 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical