Krystexxa
- Product NDC
- 75987-080
- 11-digit product format
- 759870080
- Labeler code
- 75987
- Product ID
- 75987-080_0391b7f8-de21-41a5-b125-aace02db52b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegloticase
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Horizon Therapeutics USA, Inc.
- Application
- BLA125293
- Marketing category
- BLA
- Marketing start
- 2010-09-14
- Substance
- PEGLOTICASE
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Urate Oxidase [CS], Uric Acid-specific Enzyme [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 75987-080-10 | 2023-08-07 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-08-07 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-08-07 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-08-07 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
| 75987-080-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-61d5-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA. KRYSTEXXA ® (pegloticase) injection, for intravenous use Initial U.S. Approval: 2010 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75987-080-10 | Krystexxa | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1142 |
| 75987-080-10 | Krystexxa | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1142 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75987-080 | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.] | 1140 | Current NDC, Legacy NDC, 2 package rows | 20250424_6e566303-d93a-4130-b764-25749829aa95.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75987-080-10 | 75987008010 | 1 VIAL in 1 CARTON (75987-080-10) / 1 mL in 1 VIAL | 1 vial | 2010-09-14 | 0000-00-00 | No | No | Current |