NDC 0053-7643 - Monoclate-P
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0053-7643
- Package NDCs from labels
- 0053-7643-01
- Manufacturer
- CSL Behring LLC
- Effective date
- 2018-09-18
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Monoclate-P - CSL Behring LLC | CSL Behring LLC | 2018-09-18 | PLASMA DERIVATIVE |
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.