Portrazza
- Product NDC
- 0002-7716
- Requested package NDC
- 0002-7716-01
- 11-digit product format
- 000027716
- Labeler code
- 0002
- Product ID
- 0002-7716_62de9272-71de-4b81-8ccf-ad7806f02081
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- necitumumab
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eli Lilly and Company
- Application
- BLA125547
- Marketing category
- BLA
- Marketing start
- 2015-11-24
- Marketing end
- 0000-00-00
- Substance
- NECITUMUMAB
- Active strength
- 16 mg/mL
- Pharmacologic classes
- Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0002-7716 | PORTRAZZA (NECITUMUMAB) SOLUTION [ELI LILLY AND COMPANY] | 5 | Legacy NDC | 20231216_89bcf553-669a-40b0-a9d7-67a5c1d2f591.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125547 | Portrazza | necitumumab | 351(a) | Rx | 2026-06-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0002-7716-01 | 00002771601 | 1 VIAL, SINGLE-USE in 1 CARTON (0002-7716-01) > 50 mL in 1 VIAL, SINGLE-USE | 2015-11-24 | 0000-00-00 | No | No | Current |