FDA.reportPublic FDA data

PROLASTIN-C

Product NDC
13533-706
11-digit product format
135330706
Labeler code
13533
Product ID
13533-706_6a2d2b1f-c8f1-4002-ba1e-925179974d95
Type
PLASMA DERIVATIVE
Nonproprietary name
ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
Dosage form
KIT
Labeler
GRIFOLS USA, LLC
Application
BLA103174
Marketing category
BLA
Marketing start
1987-12-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-702-11PROLASTIN-C20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL1000 mg in 20mL25
13533-706-22PROLASTIN-C1 in 1 CARTONKIT125
76297-002-22PROLASTIN-C20 mL in 1 VIAL, SINGLE-DOSESOLUTION20 mL1 mL in 1mL25

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alpha-1-proteinase Inhibitor HumanACTIVE INGREDIENTF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Alpha-1-proteinase Inhibitor HumanACTIVE MOIETYF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium PhosphateINACTIVE INGREDIENTSE337SVY37PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-706PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]25Current NDC, Legacy NDC, 3 package rows20220308_91edab72-c889-470e-8315-1798b5548dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSN91edab72-c889-470e-8315-1798b5548dca25
1661220Prolastin-C 1 MG InjectionPSN91edab72-c889-470e-8315-1798b5548dca25
1661220alpha 1-proteinase inhibitor, human 1 MG Injection [Prolastin]SBD91edab72-c889-470e-8315-1798b5548dca25
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCD91edab72-c889-470e-8315-1798b5548dca25
1661220Prolastin 1 MG InjectionSY91edab72-c889-470e-8315-1798b5548dca25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-702-111353307021120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
13533-706-22135330706221 KIT in 1 CARTON (13533-706-22) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (76297-002-22) 1 kit1987-12-020000-00-00NoNoCurrent
76297-002-227629700022220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical