FDA.reportPublic FDA data

Elrexfio

Product NDC
0069-2522
11-digit product format
000692522
Labeler code
0069
Product ID
0069-2522_0080902a-fc95-4612-8df2-1fd00bbaed23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elranatamab-bcmm
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761345
Marketing category
BLA
Marketing start
2023-08-15
Substance
ELRANATAMAB
Active strength
44 mg/1.1mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELRANATAMAB44 mg/1.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL0HR9A577V
Rxcui2644885, 2644891, 2644893, 2644894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf04f12d-3435-41d4-973b-e759446596f3Product name120241008
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-2522-01Elrexfio1.1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1.14
0069-2522-02Elrexfio1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-2522-01ML - Milliliter0069-2522c751fca4-4f13-45d4-aeb4-557c1bcf2cf412023-09-05
0069-2522-02ML - Milliliter0069-25221baffdc2-ca2f-47f0-9d85-394cd26fe39712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-2522ELREXFIO (ELRANATAMAB-BCMM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]1Current NDC, 2 package rows20230817_f6fea598-ff58-4a20-b5e8-8a51f37d8beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644885elranatamab-bcmm 44 MG in 1.1 ML InjectionPSNf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644893elranatamab-bcmm 76 MG in 1.9 ML InjectionPSNf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644891ELREXFIO 44 MG in 1.1 ML InjectionPSNf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644894ELREXFIO 76 MG in 1.9 ML InjectionPSNf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448911.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]SBDf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448941.9 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]SBDf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448851.1 ML elranatamab-bcmm 40 MG/ML InjectionSCDf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448931.9 ML elranatamab-bcmm 40 MG/ML InjectionSCDf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448911.1 ML Elrexfio 40 MG/ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
26448941.9 ML Elrexfio 40 MG/ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644885elranatamab-bcmm 44 MG per 1.1 ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644893elranatamab-bcmm 76 MG per 1.9 ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644891Elrexfio 44 MG per 1.1 ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4
2644894Elrexfio 76 MG per 1.9 ML InjectionSYf6fea598-ff58-4a20-b5e8-8a51f37d8beb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-2522-01000692522011.1 mL in 1 VIAL, SINGLE-DOSE1.1 mlHistorical
0069-2522-02000692522021 VIAL, SINGLE-DOSE in 1 CARTON (0069-2522-02) / 1.1 mL in 1 VIAL, SINGLE-DOSE (0069-2522-01) 2023-08-15NoNoHistorical