NDC 75987-145
PROCYSBI
Cysteamine Bitartrate
PROCYSBI is a Oral Granule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Cysteamine Bitartrate.
| Product ID | 75987-145_03837d9e-aee3-46e9-a893-b05a24397170 |
| NDC | 75987-145 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PROCYSBI |
| Generic Name | Cysteamine Bitartrate |
| Dosage Form | Granule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-02-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA213491 |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Substance Name | CYSTEAMINE BITARTRATE |
| Active Ingredient Strength | 300 mg/1 |
| Pharm Classes | Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 75987-145-13
60 PACKET in 1 CARTON (75987-145-13) > 1 GRANULE, DELAYED RELEASE in 1 PACKET
| Marketing Start Date | 2020-02-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 75987-145-13 [75987014513]
PROCYSBI GRANULE, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA213491 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-02-14 |
NDC 75987-145-14 [75987014514]
PROCYSBI GRANULE, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA213491 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-02-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CYSTEAMINE BITARTRATE | 300 mg/1 |
OpenFDA Data
| SPL SET ID: | d3a3ec28-f746-463a-bb92-3bc8826db09e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Cystine Depleting Agent [EPC]
- Cystine Disulfide Reduction [MoA]
NDC Crossover Matching brand name "PROCYSBI" or generic name "Cysteamine Bitartrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 75987-100 | PROCYSBI | Cysteamine bitartrate |
| 75987-101 | PROCYSBI | Cysteamine bitartrate |
| 75987-140 | PROCYSBI | Cysteamine bitartrate |
| 75987-145 | PROCYSBI | Cysteamine bitartrate |
| 0378-9040 | Cystagon | cysteamine bitartrate |
| 0378-9045 | Cystagon | cysteamine bitartrate |
Trademark Results [PROCYSBI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCYSBI 85550512 4407821 Live/Registered |
HORIZON ORPHAN LLC 2012-02-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.