ARZERRA
- Product NDC
- 0078-0690
- 11-digit product format
- 000780690
- Labeler code
- 0078
- Product ID
- 0078-0690_56665f95-5c96-4177-b65b-17928bb90b80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofatumumab
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- BLA125326
- Marketing category
- BLA
- Marketing start
- 2016-02-01
- Marketing end
- 0000-00-00
- Substance
- OFATUMUMAB
- Active strength
- 20 mg/mL
- Pharmacologic classes
- CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0078-0690 | ARZERRA (OFATUMUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 10 | Legacy NDC | 20240627_77785ce3-e8df-4ca1-8f8e-6c418c6a17de.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0690-61 | 00078069061 | 50 mL in 1 VIAL, SINGLE-USE (0078-0690-61) | 50 ml | 2016-02-01 | 0000-00-00 | No | No | Current |