Rylaze
- Product NDC
- 68727-900
- 11-digit product format
- 687270900
- Labeler code
- 68727
- Product ID
- 68727-900_cca29ff5-d000-43da-b64a-c65816a8a9c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- asparaginase erwinia chrysanthemi (recombinant)-rywn
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Jazz Pharmaceuticals, Inc.
- Application
- BLA761179
- Marketing category
- BLA
- Marketing start
- 2021-06-30
- Substance
- ASPARAGINASE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Asparaginase [CS], Asparagine-specific Enzyme [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rylaze
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASPARAGINASE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G4FQ3CKY5R |
| Rxcui | 2561251, 2561256 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68727-900-01 | Rylaze | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 0.5 | | 7 |
| 68727-900-03 | Rylaze | 3 in 1 CARTON | INJECTION | 3 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68727-900 | RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN) INJECTION [JAZZ PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241010_857e53aa-1098-4dad-b654-0276cdd43e03.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 |
|---|
| 68727-900-01 | 68727090001 | 0.5 mL in 1 VIAL, SINGLE-DOSE | 0.5 ml | | | | | Historical |
| 68727-900-03 | 68727090003 | 3 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03) / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01) | | 2021-06-30 | 0000-00-00 | No | No | Current |