WINRHO

Product NDC
70504-3100
11-digit product format
705043100
Labeler code
70504
Product ID
70504-3100_af5a44ab-5033-43c7-a3a4-eade9010bcbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rho (d) immune globulin
Dosage form
LIQUID
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Aptevo BioTherapeutics LLC
Application
BLA103649
Marketing category
BLA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
HUMAN RHO(D) IMMUNE GLOBULIN
Active strength
5000 [iU]/mL
Pharmacologic classes
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70504-3100-22023-02-01C16284748780-1d6a99b39-5216-a426-e053-dadaa90af4c2c0948763-cfc2-49fc-86b0-76abcf036f70
70504-3100-22022-01-28C16284748780-1d6a99b39-5216-a426-e053-dadaa90af4c2c0948763-cfc2-49fc-86b0-76abcf036f70

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70504-3100-1ML - Milliliter70504-31005f011129-cfed-4463-9ab6-14aac45e82ce12018-01-12
70504-3100-2ML - Milliliter70504-31004f7465d4-f016-414f-8c17-386dc4441f8012017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70504-3100-2705043100021 VIAL, SINGLE-DOSE in 1 CARTON (70504-3100-2) > 4.4 mL in 1 VIAL, SINGLE-DOSE (70504-3100-1) 2016-07-010000-00-00NoNoCurrent