Krystexxa
- Product NDC
- 54396-801
- 11-digit product format
- 543960801
- Labeler code
- 54396
- Product ID
- 54396-801_8ec18670-b429-432f-b7c5-7a43fd397c47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegloticase
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Savient Pharmaceuticals, Inc.
- Application
- BLA125293
- Marketing category
- BLA
- Marketing start
- 2010-09-14
- Marketing end
- 0000-00-00
- Substance
- PEGLOTICASE
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Urate Oxidase [CS],Uric Acid-specific Enzyme [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54396-801-01 | Krystexxa | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 54396-801-01 | Krystexxa | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PEGLOTICASE | ACTIVE INGREDIENT | R581OT55EA | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
| PEGLOTICASE | ACTIVE MOIETY | R581OT55EA | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54396-801 | KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20130419_5f4574d1-401f-4647-83e5-28c0f4a122a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 54396-801-01 | 54396080101 | 1 in 1 CARTON | Historical |