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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70257-330 | WINRHO SDF (RHO (D) IMMUNE GLOBULIN) LIQUID [SAOL THERAPEUTICS INC.] | 6 | Legacy NDC | 20240907_b8809e8b-9a6f-47d3-80de-fe46ae79f7cd.zip |
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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70257-330-51 | 70257033051 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70257-330-51) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (70257-330-11) | 2019-03-01 | 0000-00-00 | No | No | Current |