FDA.reportPublic FDA data

Akovaz

Product NDC
51754-4200
11-digit product format
517544200
Labeler code
51754
Product ID
51754-4200_5a627a89-7997-4af5-a1d0-2cedbe1bc868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ephedrine sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
NDA208289
Marketing category
NDA
Marketing start
2021-04-15
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
Akovaz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG
Rxcui1116294, 1796730, 2586841, 2586845

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
51754-4200-4Akovaz1 mL in 1 VIAL, SINGLE-DOSEINJECTION14
51754-4200-4Akovaz25 in 1 CARTONINJECTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-4200AKOVAZ (EPHEDRINE SULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC]4Current NDC, Legacy NDC, 2 package rows20221206_e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586845Akovaz 25 MG in 5 ML Prefilled SyringePSNe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
1796730Akovaz 50 MG in 1 ML InjectionPSNe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
2586841ePHEDrine sulfate 25 MG in 5 ML Prefilled SyringePSNe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
17967301 ML ephedrine sulfate 50 MG/ML Injection [Akovaz]SBDe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
25868455 ML ephedrine sulfate 5 MG/ML Prefilled Syringe [Akovaz]SBDe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
25868415 ML ephedrine sulfate 5 MG/ML Prefilled SyringeSCDe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
25868455 ML Akovaz 5 MG/ML Prefilled SyringeSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
2586845Akovaz 25 MG (equivalent to 19 MG ephedrine) per 5 ML Prefilled SyringeSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
2586845Akovaz 25 MG per 5 ML Prefilled SyringSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
1796730Akovaz 50 MG (equivalent to 38 MG ephedrine) per 1 ML InjectionSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
1796730Akovaz 50 MG per 1 ML InjectionSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
2586841ephedrine sulfate 25 MG (equivalent to 19 MG ephedrine) per 5 ML Prefilled SyringeSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYe92f3eda-33eb-4b34-9e8b-db8d32a5dbd94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-4200-45175442000425 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE2021-04-150000-00-00NoNoCurrent