NDC 0078-0708
PIQRAY
Alpelisib
PIQRAY is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Alpelisib.
| Product ID | 0078-0708_0966a539-f6fd-4cab-9d30-152f48583edd |
| NDC | 0078-0708 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PIQRAY |
| Generic Name | Alpelisib |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-05-24 |
| Marketing Category | NDA / NDA |
| Application Number | NDA212526 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | ALPELISIB |
| Active Ingredient Strength | 150 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0078-0708-02
2 BLISTER PACK in 1 CARTON (0078-0708-02) > 28 TABLET in 1 BLISTER PACK (0078-0708-51)
| Marketing Start Date | 2019-05-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0078-0708-90 [00078070890]
PIQRAY TABLET
| Marketing Category | NDA |
| Application Number | NDA212526 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-05-24 |
NDC 0078-0708-02 [00078070802]
PIQRAY TABLET
| Marketing Category | NDA |
| Application Number | NDA212526 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-24 |
NDC 0078-0708-51 [00078070851]
PIQRAY TABLET
| Marketing Category | NDA |
| Application Number | NDA212526 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-24 |
NDC 0078-0708-91 [00078070891]
PIQRAY TABLET
| Marketing Category | NDA |
| Application Number | NDA212526 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-05-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ALPELISIB | 150 mg/1 |
OpenFDA Data
| SPL SET ID: | b20b4e18-7a4b-4500-a08f-06c6dab0ee5b |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "PIQRAY" or generic name "Alpelisib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0701 | PIQRAY | alpelisib |
| 0078-0708 | PIQRAY | alpelisib |
| 0078-0715 | PIQRAY | alpelisib |
| 0078-1021 | VIJOICE | alpelisib |
| 0078-1028 | VIJOICE | alpelisib |
| 0078-1035 | VIJOICE | alpelisib |
Trademark Results [PIQRAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIQRAY 86279420 not registered Dead/Abandoned |
Novartis AG 2014-05-13 |
 PIQRAY 79219218 5415224 Live/Registered |
NOVARTIS AG 2017-08-23 |
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