REOPRO
- Product NDC
- 57894-200
- 11-digit product format
- 578940200
- Labeler code
- 57894
- Product ID
- 57894-200_6ca121f6-67e6-11e9-9d6a-9ec70099106d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abciximab
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA103575
- Marketing category
- BLA
- Marketing start
- 2017-01-03
- Marketing end
- 0000-00-00
- Substance
- ABCIXIMAB
- Active strength
- 2 mg/mL
- 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 product | product | 57894-200 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 57894-200 | 57894-200-01 | D | Discontinued by firm | 2026-07-31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57894-200-01 | ML - Milliliter | 57894-200 | 96c6a46b-b898-42c2-9797-3491ef1cdaa2 | 1 | 2017-03-06 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103575 | Reopro | abciximab | 351(a) | Disc | 2026-06-01 |