WinRho SDF
- Product NDC
- 70257-350
- 11-digit product format
- 702570350
- Labeler code
- 70257
- Product ID
- 70257-350_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
- 2500 [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 |
|---|
| 70257-350 | WINRHO SDF (RHO (D) IMMUNE GLOBULIN) LIQUID [SAOL THERAPEUTICS INC.] | 6 | Legacy NDC | 20240907_b8809e8b-9a6f-47d3-80de-fe46ae79f7cd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70257-350-51 | 70257035051 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70257-350-51) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (70257-350-02) | 2019-03-01 | 0000-00-00 | No | No | Current |