Monoclate-P
- Product NDC
- 0053-7632
- 11-digit product format
- 000537632
- Labeler code
- 0053
- Product ID
- 0053-7632_bff9194c-d40c-417d-9538-97d8d6b0908c
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ANTIHEMOPHILIC FACTOR HUMAN
- Dosage form
- KIT
- Labeler
- CSL Behring LLC
- Application
- BLA103953
- Marketing category
- BLA
- Marketing start
- 1990-05-30
- Marketing end
- 0000-00-00
- Active strength
- 0
- 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 | 0053-7632 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0053-7632 | 0053-7632-02 | D | Discontinued by firm | 2026-07-31 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE INGREDIENT | 839MOZ74GK | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE MOIETY | 839MOZ74GK | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | MONOCLATE-P (ANTIHEMOPHILIC FACTOR HUMAN) KIT [CSL BEHRING LLC] | 7 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | Disc | 2026-06-01 |