WINRHO

Product NDC: 70504-3000
Requested package NDC: 70504-3000-2
11-digit product format: 705043000
Labeler code: 70504
Product ID: 70504-3000_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: 15000 [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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70504-3000	70504-3000-2	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70504-3000-2	2023-02-01	C162847	48780-1	d6a99b39-5216-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use WinRho ® SDF safely and effectively. See full prescribing information for WinRho ® SDF. WinRho ® SDF [Rh o (D) Immune Globulin Intravenous (Human)] Solution for Intravenous or Intramuscular Injection Initial U.S. Approval: 1995
70504-3000-2	2022-01-28	C162847	48780-1	d6a99b39-5216-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use WinRho ® SDF safely and effectively. See full prescribing information for WinRho ® SDF. WinRho ® SDF [Rh o (D) Immune Globulin Intravenous (Human)] Solution for Intravenous or Intramuscular Injection Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70504-3000-1	ML - Milliliter	70504-3000	e0e087d7-a49f-4470-ae3b-2bf5f47e7b3f	1	2018-01-12
70504-3000-2	ML - Milliliter	70504-3000	e3145e17-97aa-463b-8d41-d92705090608	1	2017-03-06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103649	Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	Rho(D) Immune Globulin Intravenous (Human)	351(a)	Disc	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
48W7181FLP	HUMAN RHO(D) IMMUNE GLOBULIN	HUMAN RHO(D) IMMUNE GLOBULIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70504-3000-2	70504300002	1 VIAL, SINGLE-DOSE in 1 CARTON (70504-3000-2) > 13 mL in 1 VIAL, SINGLE-DOSE (70504-3000-1)	2016-07-01	0000-00-00	No	No	Current