FDA.reportPublic FDA data

Prolastin-C Liquid

Product NDC
13533-705
11-digit product format
135330705
Labeler code
13533
Product ID
13533-705_f3f69bd6-df32-45c4-bbd9-b18b0d725382
Type
PLASMA DERIVATIVE
Nonproprietary name
Alpha1-Proteinase Inhibitor (Human)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA103174
Marketing category
BLA
Marketing start
1987-12-02
Substance
.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Active strength
1000 mg/20mL
Pharmacologic classes
Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]
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 Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.1-PROTEINASE INHIBITOR HUMAN1000 mg/20mL

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
13533-705-01Prolastin-C Liquid1 in 1 CARTONINJECTION, SOLUTION114
13533-705-11Prolastin-C Liquid20 mL in 1 VIALINJECTION, SOLUTION2014
13533-705-31Prolastin-C Liquid1 in 1 CARTONINJECTION, SOLUTION114
13533-705-32Prolastin-C Liquid10 mL in 1 VIALINJECTION, SOLUTION1014
13533-705-51Prolastin-C Liquid1 in 1 CARTONINJECTION, SOLUTION114
13533-705-52Prolastin-C Liquid80 mL in 1 VIALINJECTION, SOLUTION8014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-705-01EA - Each13533-705c405c690-672b-4ea6-9ae2-a0f401deddbe12018-02-20
13533-705-11EA - Each13533-7058123ca96-5a33-443f-8070-53f5900ccf6f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-705PROLASTIN-C LIQUID (ALPHA1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]14Current NDC, Legacy NDC, 6 package rows20220707_2b620e6b-6a24-0957-1288-ae529c4cc3a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSN2b620e6b-6a24-0957-1288-ae529c4cc3a214
1661220Prolastin-C 1 MG InjectionPSN2b620e6b-6a24-0957-1288-ae529c4cc3a214
1661220alpha 1-proteinase inhibitor, human 1 MG Injection [Prolastin]SBD2b620e6b-6a24-0957-1288-ae529c4cc3a214
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCD2b620e6b-6a24-0957-1288-ae529c4cc3a214
1661220Prolastin 1 MG InjectionSY2b620e6b-6a24-0957-1288-ae529c4cc3a214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-705-01135330705011 VIAL in 1 CARTON (13533-705-01) / 20 mL in 1 VIAL (13533-705-11) 1 vial1987-12-020000-00-00NoNoCurrent
13533-705-111353307051120 mL in 1 VIAL20 mlHistorical
13533-705-31135330705311 VIAL in 1 CARTON (13533-705-31) / 10 mL in 1 VIAL (13533-705-32) 1 vial1987-12-020000-00-00NoNoCurrent
13533-705-321353307053210 mL in 1 VIAL10 mlHistorical
13533-705-51135330705511 VIAL in 1 CARTON (13533-705-51) / 80 mL in 1 VIAL (13533-705-52) 1 vial1987-12-020000-00-00NoNoCurrent
13533-705-521353307055280 mL in 1 VIAL80 mlHistorical