Yorvipath
- Product NDC
- 73362-101
- 11-digit product format
- 733620101
- Labeler code
- 73362
- Product ID
- 73362-101_eb81bad9-a369-4eeb-a69e-6920924381b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palopegteriparatide
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Ascendis Pharma, Endocrinology, Inc.
- Application
- NDA216490
- Marketing category
- NDA
- Marketing start
- 2024-08-09
- Substance
- PALOPEGTERIPARATIDE
- Active strength
- 294 ug/.98mL
- Pharmacologic classes
- Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Yorvipath
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALOPEGTERIPARATIDE | 294 ug/.98mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G2N64C3385 |
| Rxcui | 2693637, 2693643, 2693645, 2693646, 2693647, 2693648 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b921a6be-c897-e1d4-f6d7-f4df8c2a7a6a | Product name | 2 | 20250731 |
| bc54407b-4c2b-4714-a018-cf90828b0cb1 | Product name | 1 | 20250317 |
| 25117fd6-247a-42b6-bd01-89f9877d0f51 | Product name | 1 | 20200304 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73362-101-01 | Yorvipath | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | 7 | |
| 73362-101-02 | Yorvipath | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 7 | |
| 73362-101-03 | Yorvipath | 0.98 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 0.98 | 7 | |
| 73362-101-03 | Yorvipath | 1 in 1 SYRINGE | INJECTION, SOLUTION | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73362-101-01 | ML - Milliliter | 73362-101 | b767f007-530d-4ac4-84d6-bc509b871b0d | 1 | 2024-10-04 |
| 73362-101-03 | ML - Milliliter | 73362-101 | 9665c3ab-7b49-4a00-a4c6-073cec62acb0 | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2693637 | palopegteriparatide 168 MCG in 0.56 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693645 | palopegteriparatide 294 MCG in 0.98 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693647 | palopegteriparatide 420 MCG in 1.4 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693643 | Yorvipath 168 MCG in 0.56 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693646 | Yorvipath 294 MCG in 0.98 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693648 | Yorvipath 420 MCG in 1.4 ML Pen Injector | PSN | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693643 | 0.56 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath] | SBD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693646 | 0.98 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath] | SBD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693648 | 1.4 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath] | SBD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693637 | 0.56 ML teriparatide 0.3 MG/ML Pen Injector | SCD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693645 | 0.98 ML teriparatide 0.3 MG/ML Pen Injector | SCD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693647 | 1.4 ML teriparatide 0.3 MG/ML Pen Injector | SCD | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693643 | 0.56 ML Yorvipath 0.3 MG/ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693646 | 0.98 ML Yorvipath 0.3 MG/ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693648 | 1.4 ML Yorvipath 0.3 MG/ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693637 | teriparatide 168 MCG (equivalent to palopegteriparatide 1935 MCG) per 0.56 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693645 | teriparatide 294 MCG (equivalent to palopegteriparatide 3387 MCG) per 0.98 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693647 | teriparatide 420 MCG (equivalent to palopegteriparatide 4838 MCG) per 1.4 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693643 | Yorvipath 168 MCG per 0.56 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693646 | Yorvipath 294 MCG per 0.98 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
| 2693648 | Yorvipath 420 MCG per 1.4 ML Pen Injector | SY | a1fa23fd-c434-443e-9a17-5750578c8602 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 73362-101-01 | 73362010101 | 2 BOX in 1 CARTON (73362-101-01) / 1 SYRINGE in 1 BOX (73362-101-02) / 1 CARTRIDGE in 1 SYRINGE (73362-101-03) / .98 mL in 1 CARTRIDGE | 2 box | 2024-08-09 | No | No | Current |
| 73362-101-02 | 73362010102 | 1 in 1 BOX | Historical | ||||
| 73362-101-03 | 73362010103 | 0.98 mL in 1 CARTRIDGE | 0.98 ml | Historical |