FDA.reportPublic FDA data

ASCENIV

Product NDC
69800-0250
11-digit product format
698000250
Labeler code
69800
Product ID
69800-0250_4ecc6123-99fa-fa43-e063-6294a90a548f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HUMAN IMMUNOGLOBULIN G
Dosage form
LIQUID
Route
INTRAVENOUS
Labeler
ADMA Biologics, Inc.
Application
BLA125590
Marketing category
BLA
Marketing start
2019-04-01
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
5 g/50mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ASCENIV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii66Y330CJHS
Rxcui2123037, 2123042

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69800-0250-1ASCENIV1 in 1 CARTONLIQUID112
69800-0250-2ASCENIV50 mL in 1 VIAL, SINGLE-USELIQUID5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69800-0250-1ML - Milliliter69800-0250bf98ffaf-8554-4d92-85be-8fc355c600ab12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69800-0250ASCENIV (HUMAN IMMUNOGLOBULIN G) LIQUID [ADMA BIOLOGICS, INC.]11Current NDC, Legacy NDC, 2 package rows20250507_d74f4360-3b51-496c-96fb-84c3976958d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123042ASCENIV 10 % in 50 ML InjectionPSNd74f4360-3b51-496c-96fb-84c3976958d212
2123037immune globulin intravenous (human) - slra 10 % in 50 ML InjectionPSNd74f4360-3b51-496c-96fb-84c3976958d212
212304250 ML immune globulin intravenous (human) - slra 100 MG/ML Injection [Asceniv]SBDd74f4360-3b51-496c-96fb-84c3976958d212
212303750 ML immune globulin intravenous (human) - slra 100 MG/ML InjectionSCDd74f4360-3b51-496c-96fb-84c3976958d212
212304250 ML Asceniv 100 MG/ML InjectionSYd74f4360-3b51-496c-96fb-84c3976958d212
2123042ASCENIV 10 % per 50 ML InjectionSYd74f4360-3b51-496c-96fb-84c3976958d212
2123037immune globulin intravenous (human) - slra 10 % per 50 ML InjectionSYd74f4360-3b51-496c-96fb-84c3976958d212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69800-0250-1698000250011 VIAL, SINGLE-USE in 1 CARTON (69800-0250-1) / 50 mL in 1 VIAL, SINGLE-USE (69800-0250-2) 2019-04-010000-00-00NoNoCurrent
69800-0250-26980002500250 mL in 1 VIAL, SINGLE-USE50 mlHistorical