RYZNEUTA

Product NDC
72893-016
11-digit product format
728930016
Labeler code
72893
Product ID
72893-016_523867f4-dbc4-1258-e063-6394a90a3145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
efbemalenograstim alfa-vuxw
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Acrotech Biopharma Inc
Application
BLA761134
Marketing category
BLA
Marketing start
2023-11-23
Substance
EFBEMALENOGRASTIM ALFA
Active strength
20 mg/mL
Pharmacologic classes
Colony-Stimulating Factors [CS], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RYZNEUTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EFBEMALENOGRASTIM ALFA20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5UPW5HJW3OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670662Internal RxNorm lookup
2670669Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
290ed754-758c-9cae-e063-6294a90ae68bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6439f3dd-c080-443b-80be-fa55e5605ccbProduct name120250731
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72893-016-02RYZNEUTA1 in 1 CARTONINJECTION17
72893-016-02RYZNEUTA1 mL in 1 SYRINGEINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72893-016-02ML - Milliliter72893-0169734992e-f941-4f39-8867-70b1b731ce2112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72893-016RYZNEUTA (EFBEMALENOGRASTIM ALFA-VUXW) INJECTION [ACROTECH BIOPHARMA INC]4Current NDC, 2 package rows20241220_290ed754-758c-9cae-e063-6294a90ae68b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RYZNEUTAEFBEMALENOGRASTIM ALFA-VUXWAcrotech Biopharma Inc290ed754-758c-9cae-e063-6294a90ae68b2026-05-19Warnings, Adverse reactionsExact identifier
application number: BLA761134
ndc (product): 72893-016

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761134Ryzneutaefbemalenograstim alfa-vuxw351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2670662efbemalenograstim alfa-vuxw 20 MG in 1 ML Prefilled SyringePSN290ed754-758c-9cae-e063-6294a90ae68b7
2670669Ryzneuta 20 MG in 1 ML Prefilled SyringePSN290ed754-758c-9cae-e063-6294a90ae68b7
26706691 ML efbemalenograstim alfa-vuxw 20 MG/ML Prefilled Syringe [Ryzneuta]SBD290ed754-758c-9cae-e063-6294a90ae68b7
26706621 ML efbemalenograstim alfa-vuxw 20 MG/ML Prefilled SyringeSCD290ed754-758c-9cae-e063-6294a90ae68b7
26706691 ML Ryzneuta 20 MG/ML Prefilled SyringeSY290ed754-758c-9cae-e063-6294a90ae68b7
2670662efbemalenograstim alfa-vuxw 20 MG per 1 ML Prefilled SyringeSY290ed754-758c-9cae-e063-6294a90ae68b7
2670669Ryzneuta 20 MG per 1 ML Prefilled SyringeSY290ed754-758c-9cae-e063-6294a90ae68b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72893-016-02728930016021 SYRINGE in 1 CARTON (72893-016-02) / 1 mL in 1 SYRINGE1 syringe2023-11-23NoNoCurrent