WinRho SDF

Product NDC
70257-330
11-digit product format
702570330
Labeler code
70257
Product ID
70257-330_40b487d4-5658-437b-99de-c0130d5d6bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rho (d) immune globulin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Saol Therapeutics Inc.
Application
BLA103649
Marketing category
BLA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
HUMAN RHO(D) IMMUNE GLOBULIN
Active strength
1500 [iU]/1
Pharmacologic classes
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-330-11ML - Milliliter70257-330014f152f-ccb1-4af5-ad6d-35bf69fb4d7f12019-04-11
70257-330-51ML - Milliliter70257-330f75dd633-570a-4865-af43-2cf5d6ddc2e512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70257-330WINRHO SDF (RHO (D) IMMUNE GLOBULIN) LIQUID [SAOL THERAPEUTICS INC.]6Legacy NDC20240907_b8809e8b-9a6f-47d3-80de-fe46ae79f7cd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70257-330-51702570330511 VIAL, SINGLE-DOSE in 1 CARTON (70257-330-51) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (70257-330-11) 2019-03-010000-00-00NoNoCurrent