NUWIQ

Product NDC
68982-153
11-digit product format
689820153
Labeler code
68982
Product ID
68982-153_0868958e-3f70-f70a-5acd-bb3d002fe86f
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor (Recombinant)
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125555
Marketing category
BLA
Marketing start
2021-12-12
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-153-01NUWIQ1 in 1 CARTONKIT116
68982-154-01NUWIQ2.5 mL in 1 VIALPOWDER, FOR SOLUTION2.5 mL1500 [iU] in 2.5mL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-153-01EA - Each68982-153d4ad81f3-b3f8-454b-a456-ff16adb2d77412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-153NUWIQ (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [OCTAPHARMA USA INC]16Current NDC, Legacy NDC, 2 package rows20250201_d6cb51f8-3acd-412c-93ec-41a8017dff3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729091NUWIQ 1 UNT InjectionPSNd6cb51f8-3acd-412c-93ec-41a8017dff3e16
1729086simoctocog alfa 1 UNT InjectionPSNd6cb51f8-3acd-412c-93ec-41a8017dff3e16
1729091simoctocog alfa 1 UNT Injection [Nuwiq]SBDd6cb51f8-3acd-412c-93ec-41a8017dff3e16
1729086simoctocog alfa 1 UNT InjectionSCDd6cb51f8-3acd-412c-93ec-41a8017dff3e16
1729086coagulation factor VIII, B-domain deleted recombinant 1 UNT InjectionSYd6cb51f8-3acd-412c-93ec-41a8017dff3e16
1729091Nuwiq 1 UNT InjectionSYd6cb51f8-3acd-412c-93ec-41a8017dff3e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-153-01689820153011 KIT in 1 CARTON (68982-153-01) * 2.5 mL in 1 VIAL (68982-154-01) * 2.5 mL in 1 VIAL (68982-901-01) 1 kit2021-12-120000-00-00NoNoCurrent
68982-154-01689820154012.5 mL in 1 VIAL2.5 mlHistorical