WINRHO
- Product NDC
- 70504-3300
- Requested package NDC
- 70504-3300-2
- 11-digit product format
- 705043300
- Labeler code
- 70504
- Product ID
- 70504-3300_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
- 1500 [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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70504-3300 | 70504-3300-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70504-3300 | 70504-3300-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70504-3300 | 70504-3300-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70504-3300 | 70504-3300-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 70504-3300 | 70504-3300-2 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70504-3300-1 | ML - Milliliter | 70504-3300 | 7a7c426c-e364-4ffb-9758-a334ea56de12 | 1 | 2018-01-12 |
| 70504-3300-2 | ML - Milliliter | 70504-3300 | 421ad62d-c69b-4e3a-acfd-564b85e39482 | 1 | 2017-03-06 |
Purple Book Biologic Products#
| 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70504-3300-2 | 70504330002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70504-3300-2) > 1.3 mL in 1 VIAL, SINGLE-DOSE (70504-3300-1) | 2016-07-01 | 0000-00-00 | No | No | Current |