Ephedrine Sulfate

Product NDC
70121-1637
11-digit product format
701211637
Labeler code
70121
Product ID
70121-1637_15f1d276-c5fd-4ad5-8b02-a48a6843eb2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA212932
Marketing category
ANDA
Marketing start
2019-10-23
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
70121-1637-1Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION110
70121-1637-5Ephedrine Sulfate25 in 1 CARTONINJECTION2510
70121-1637-7Ephedrine Sulfate10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1637-1ML - Milliliter70121-16376b867d5b-53da-4262-871b-f4755680370912019-11-12
70121-1637-5ML - Milliliter70121-16371e1982c4-5a07-4bfc-8c8d-31da0ad69c2812019-11-12
70121-1637-7ML - Milliliter70121-1637d0ee35be-7a5e-4075-a875-26ebe522668d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1637EPHEDRINE SULFATE INJECTION [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 3 package rows20241215_765ed48b-b381-418a-9847-068f7f4cc838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN765ed48b-b381-418a-9847-068f7f4cc83810
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD765ed48b-b381-418a-9847-068f7f4cc83810
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY765ed48b-b381-418a-9847-068f7f4cc83810
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNd163ff39-d1a4-b61f-e053-2995a90ab6d53
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDd163ff39-d1a4-b61f-e053-2995a90ab6d53
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYd163ff39-d1a4-b61f-e053-2995a90ab6d53
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNc8e8ec0e-988b-85a1-e053-2a95a90a22682
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDc8e8ec0e-988b-85a1-e053-2a95a90a22682
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYc8e8ec0e-988b-85a1-e053-2a95a90a22682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1637-1701211637011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
70121-1637-57012116370525 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) 2019-10-230000-00-00NoNoCurrent
70121-1637-77012116370710 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) 2019-10-230000-00-00NoNoCurrent