Palynziq
- Product NDC
- 68135-058
- 11-digit product format
- 681350058
- Labeler code
- 68135
- Product ID
- 68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegvaliase-pqpz
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- BioMarin Pharmaceutical Inc.
- Application
- BLA761079
- Marketing category
- BLA
- Marketing start
- 2018-05-24
- Substance
- PEGVALIASE
- Active strength
- 2.5 mg/.5mL
- Pharmacologic classes
- Phenylalanine Ammonia-Lyase [CS], Phenylalanine Metabolizing Enzyme [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Palynziq
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGVALIASE | 2.5 mg/.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | N6UAH27EUV |
| Rxcui | 2046365, 2046370, 2046374, 2046376, 2046379, 2046380 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 11b26f26-d565-4782-b64a-ee0c8fe3b7d0 | Product name | 1 | 20180731 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68135-058-89 | Palynziq | 0.5 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.5 | 36 | |
| 68135-058-90 | Palynziq | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 36 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68135-058-89 | ML - Milliliter | 68135-058 | 7107df66-3c1b-472b-a159-c875285669f1 | 1 | 2019-08-06 |
| 68135-058-90 | ML - Milliliter | 68135-058 | 376e4dfa-4593-4cf5-b579-0e7f1dd8d357 | 1 | 2018-06-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2046370 | Palynziq 10 MG in 0.5 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046376 | Palynziq 2.5 MG in 0.5 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046380 | Palynziq 20 MG in 1 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046365 | pegvaliase-pqpz 10 MG in 0.5 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046374 | pegvaliase-pqpz 2.5 MG in 0.5 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046379 | pegvaliase-pqpz 20 MG in 1 mL Prefilled Syringe | PSN | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046370 | 0.5 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe [Palynziq] | SBD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046376 | 0.5 ML pegvaliase-pqpz 5 MG/ML Prefilled Syringe [Palynziq] | SBD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046380 | 1 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe [Palynziq] | SBD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046365 | 0.5 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe | SCD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046374 | 0.5 ML pegvaliase-pqpz 5 MG/ML Prefilled Syringe | SCD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046379 | 1 ML pegvaliase-pqpz 20 MG/ML Prefilled Syringe | SCD | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046370 | 0.5 ML Palynziq 20 MG/ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046376 | 0.5 ML Palynziq 5 MG/ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046380 | 1 ML Palynziq 20 MG/ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046370 | Palynziq 10 MG per 0.5 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046376 | Palynziq 2.5 MG per 0.5 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046380 | Palynziq 20 MG per 1 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046365 | pegvaliase-pqpz 10 MG per 0.5 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046374 | pegvaliase-pqpz 2.5 MG per 0.5 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
| 2046379 | pegvaliase-pqpz 20 MG per 1 ML Prefilled Syringe | SY | 6dba844a-db02-44f8-8593-ce497ed9406c | 36 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68135-058-89 | 68135005889 | 0.5 mL in 1 SYRINGE | 0.5 ml | Historical | ||||
| 68135-058-90 | 68135005890 | 1 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89) | 1 syringe | 2018-05-24 | 0000-00-00 | No | No | Current |