PYLARIFY
- Product NDC
- 71258-022
- 11-digit product format
- 712580022
- Labeler code
- 71258
- Product ID
- 71258-022_db2acb00-3e3b-4ecc-b532-08e456075404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIFLUFOLASTAT F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Progenics Pharmaceuticals, Inc.
- Application
- NDA214793
- Marketing category
- NDA
- Marketing start
- 2021-05-26
- Substance
- PIFLUFOLASTAT F-18
- Active strength
- 80 mCi/mL
- Pharmacologic classes
- Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PYLARIFY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIFLUFOLASTAT F-18 | 80 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3934EF02T7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71258-022-01 | PYLARIFY | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION | 50 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71258-022 | PYLARIFY (PIFLUFOLASTAT F-18) INJECTION [PROGENICS PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20250308_a00e5cbc-4fd5-4280-82ec-cd3498df4553.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71258-022-00 | 71258002200 | 5 mL in 1 SYRINGE (71258-022-00) | 5 ml | 2021-05-26 | 0000-00-00 | No | No | Current |
| 71258-022-01 | 71258002201 | 50 mL in 1 VIAL, MULTI-DOSE (71258-022-01) | 50 ml | 2021-05-26 | 0000-00-00 | No | No | Current |