NDC 68135-673
Palynziq
Pegvaliase-pqpz
Palynziq is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Pegvaliase.
| Product ID | 68135-673_13686fc1-3709-4731-9500-dd9d53a48d12 |
| NDC | 68135-673 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Palynziq |
| Generic Name | Pegvaliase-pqpz |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2018-05-24 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761079 |
| Labeler Name | BioMarin Pharmaceutical Inc. |
| Substance Name | PEGVALIASE |
| Active Ingredient Strength | 20 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 68135-673-40
1 SYRINGE in 1 CARTON (68135-673-40) > 1 mL in 1 SYRINGE (68135-673-39)
| Marketing Start Date | 2018-05-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68135-673-45 [68135067345]
Palynziq INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-05-24 |
NDC 68135-673-39 [68135067339]
Palynziq INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-05-24 |
NDC 68135-673-40 [68135067340]
Palynziq INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761079 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-05-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PEGVALIASE | 20 mg/mL |
OpenFDA Data
| SPL SET ID: | 6dba844a-db02-44f8-8593-ce497ed9406c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Palynziq" or generic name "Pegvaliase-pqpz"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68135-058 | Palynziq | pegvaliase-pqpz |
| 68135-673 | Palynziq | pegvaliase-pqpz |
| 68135-756 | Palynziq | pegvaliase-pqpz |
Trademark Results [Palynziq]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALYNZIQ 87978318 5577454 Live/Registered |
Biomarin Pharmaceutical Inc. 2017-07-05 |
 PALYNZIQ 87516947 not registered Live/Pending |
Biomarin Pharmaceutical Inc. 2017-07-05 |
 PALYNZIQ 87516646 not registered Live/Pending |
Biomarin Pharmaceutical Inc. 2017-07-05 |
 PALYNZIQ 87516640 5576853 Live/Registered |
Biomarin Pharmaceutical Inc. 2017-07-05 |
 PALYNZIQ 87095019 5581302 Live/Registered |
Biomarin Pharmaceutical Inc. 2016-07-06 |
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