rylaze

Generic: asparaginase erwinia chrysanthemi (recombinant)-rywn

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name rylaze
Generic Name asparaginase erwinia chrysanthemi (recombinant)-rywn
Labeler jazz pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

asparaginase 20 mg/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-900
Product ID 68727-900_cca29ff5-d000-43da-b64a-c65816a8a9c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761179
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

Pharmacologic Class

Established (EPC)
asparagine-specific enzyme [epc]
Chemical Structure
asparaginase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727900
Hyphenated Format 68727-900

Supplemental Identifiers

RxCUI
2561251 2561256
UNII
G4FQ3CKY5R
NUI
M0001815 N0000175669

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rylaze (source: ndc)
Generic Name asparaginase erwinia chrysanthemi (recombinant)-rywn (source: ndc)
Application Number BLA761179 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 3 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03) / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01)
source: ndc

Packages (1)

68727-900-03 3 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03) / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01)

Ingredients (1)

asparaginase (20 mg/mL)

Linked Drug Pages (1)

Rylaze ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "cca29ff5-d000-43da-b64a-c65816a8a9c4", "openfda": {"nui": ["M0001815", "N0000175669"], "unii": ["G4FQ3CKY5R"], "rxcui": ["2561251", "2561256"], "spl_set_id": ["857e53aa-1098-4dad-b654-0276cdd43e03"], "pharm_class_cs": ["Asparaginase [CS]"], "pharm_class_epc": ["Asparagine-specific Enzyme [EPC]"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03)  / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01)", "package_ndc": "68727-900-03", "marketing_start_date": "20210630"}], "brand_name": "Rylaze", "product_id": "68727-900_cca29ff5-d000-43da-b64a-c65816a8a9c4", "dosage_form": "INJECTION", "pharm_class": ["Asparaginase [CS]", "Asparagine-specific Enzyme [EPC]"], "product_ndc": "68727-900", "generic_name": "asparaginase erwinia chrysanthemi (recombinant)-rywn", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rylaze", "active_ingredients": [{"name": "ASPARAGINASE", "strength": "20 mg/mL"}], "application_number": "BLA761179", "marketing_category": "BLA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}