Plasmanate

Product NDC
13533-613
11-digit product format
135330613
Labeler code
13533
Product ID
13533-613_95aedb83-dbde-418c-bd54-67e580b67c75
Type
PLASMA DERIVATIVE
Nonproprietary name
Plasma Protein Fraction (Human)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA101140
Marketing category
BLA
Marketing start
1958-10-02
Substance
ALBUMIN HUMAN
Active strength
2.5 g/50mL
Pharmacologic classes
Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plasmanate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN2.5 g/50mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-613-25Plasmanate1 in 1 CARTONSOLUTION111
13533-613-26Plasmanate250 mL in 1 VIALSOLUTION25011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-613-20ML - Milliliter13533-613fc45fd19-9431-49e9-86f5-6d43a6941e2612012-07-24
13533-613-21ML - Milliliter13533-613f2ed841f-61e6-4c8c-83bf-50f6f9bf154a12014-01-04
13533-613-25ML - Milliliter13533-6134226c79c-1a4f-457c-834f-55801896b47412012-07-24
13533-613-26ML - Milliliter13533-61378a94c56-6c91-45c1-a845-fd51c6a6586612014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (human)ACTIVE INGREDIENTZIF514RVZRPLASMANATE (PLASMA PROTEIN FRACTION (HUMAN)) SOLUTION [GRIFOLS USA, LLC]5
Albumin (human)ACTIVE MOIETYZIF514RVZRPLASMANATE (PLASMA PROTEIN FRACTION (HUMAN)) SOLUTION [GRIFOLS USA, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-613PLASMANATE (PLASMA PROTEIN FRACTION (HUMAN)) SOLUTION [GRIFOLS USA, LLC]11Current NDC, Legacy NDC, 2 package rows20250507_679bbaf2-b082-5948-8400-ece5340eabc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729443plasma protein fraction 12.5 GM in 250 ML (5 % ) InjectionPSN679bbaf2-b082-5948-8400-ece5340eabc111
1729444Plasmanate 12.5 GM in 250 ML (5 % ) InjectionPSN679bbaf2-b082-5948-8400-ece5340eabc111
1729444250 ML plasma protein fraction 50 MG/ML Injection [Plasmanate]SBD679bbaf2-b082-5948-8400-ece5340eabc111
1729443250 ML plasma protein fraction 50 MG/ML InjectionSCD679bbaf2-b082-5948-8400-ece5340eabc111
1729443plasma protein fraction 12.5 GM per 250 ML InjectionSY679bbaf2-b082-5948-8400-ece5340eabc111
1729444Plasmanate 12.5 GM per 250 ML InjectionSY679bbaf2-b082-5948-8400-ece5340eabc111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-613-20135330613201 VIAL in 1 CARTON (13533-613-20) > 50 mL in 1 VIAL (13533-613-21) 1 vial1958-10-020000-00-00NoNoCurrent
13533-613-25135330613251 VIAL in 1 CARTON (13533-613-25) / 250 mL in 1 VIAL (13533-613-26) 1 vial1958-10-020000-00-00NoNoCurrent
13533-613-2613533061326250 mL in 1 VIAL250 mlHistorical
13533-613-27135330613271 VIAL in 1 CARTON (13533-613-27) > 500 mL in 1 VIAL (13533-613-28) 1 vial1958-10-020000-00-00NoNoCurrent