Azedra
- Product NDC
- 71258-015
- 11-digit product format
- 712580015
- Labeler code
- 71258
- Product ID
- 71258-015_20fd0c7f-7325-44a2-9faa-37874de7576e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iobenguane I-131
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Progenics Pharmaceuticals, Inc.
- Application
- NDA209607
- Marketing category
- NDA
- Marketing start
- 2018-07-30
- Marketing end
- 0000-00-00
- Substance
- IOBENGUANE I-131
- Active strength
- 15 mCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71258-015-02 | 71258001502 | 1 CONTAINER in 1 BOX, UNIT-DOSE (71258-015-02) > 1 VIAL, GLASS in 1 CONTAINER > 2 mL in 1 VIAL, GLASS | 1 container | 2018-07-30 | 0000-00-00 | No | No | Current |
| 71258-015-22 | 71258001522 | 1 CONTAINER in 1 BOX, UNIT-DOSE (71258-015-22) > 1 VIAL, GLASS in 1 CONTAINER > 22.5 mL in 1 VIAL, GLASS | 1 container | 2018-07-30 | 0000-00-00 | No | No | Current |