FDA.reportPublic FDA data

ABRILADA

Product NDC
0025-0325
11-digit product format
000250325
Labeler code
0025
Product ID
0025-0325_0989d777-c225-46a6-854e-01bdf4f19679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-afzb
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761118
Marketing category
BLA
Marketing start
2023-12-14
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2668064, 2668071, 2668074, 2668078, 2668095, 2668096, 2668105, 2668106, 2668109, 2668113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-0318-01ABRILADA0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.8 mL40 mg in 0.8mL8
0025-0325-01ABRILADA1 in 1 CARTONKIT18
0025-0325-01ABRILADA1 in 1 KITKIT18
0025-0325-02ABRILADA2 in 1 CARTONKIT28
0025-0325-02ABRILADA1 in 1 KITKIT18
0069-1111-01ABRILADA1 mL in 1 PACKETSWAB1 mL70 mL in 100mL8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-0325-01EA - Each0025-032508858b18-8fd0-470f-8cd3-f49be4ac396912024-01-04
0025-0325-02EA - Each0025-0325369ddf8f-c70b-4053-b33b-230fd039786c12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-0325ABRILADA (ADALIMUMAB-AFZB) KIT ABRILADA (ADALIMUMAB-AFZB) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]5Current NDC, 6 package rows20250116_5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668106Abrilada 10 MG in 0.2 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668096Abrilada 20 MG in 0.4 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668071Abrilada 40 MG in 0.8 ML Auto-InjectorPSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668113Abrilada 40 MG in 0.8 ML InjectionPSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668078Abrilada 40 MG in 0.8 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668105adalimumab-afzb 10 MG in 0.2 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668095adalimumab-afzb 20 MG in 0.4 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668064adalimumab-afzb 40 MG in 0.8 ML Auto-InjectorPSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668109adalimumab-afzb 40 MG in 0.8 ML InjectionPSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668074adalimumab-afzb 40 MG in 0.8 ML Prefilled SyringePSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
797544isopropyl alcohol 70 % Medicated PadPSN5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26681060.2 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]SBD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680960.4 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]SBD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680710.8 ML adalimumab-afzb 50 MG/ML Auto-Injector [Abrilada]SBD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26681130.8 ML adalimumab-afzb 50 MG/ML Injection [Abrilada]SBD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680780.8 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]SBD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26681050.2 ML adalimumab-afzb 50 MG/ML Prefilled SyringeSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680950.4 ML adalimumab-afzb 50 MG/ML Prefilled SyringeSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680640.8 ML adalimumab-afzb 50 MG/ML Auto-InjectorSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26681090.8 ML adalimumab-afzb 50 MG/ML InjectionSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
26680740.8 ML adalimumab-afzb 50 MG/ML Prefilled SyringeSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668106Abrilada 10 MG per 0.2 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668096Abrilada 20 MG per 0.4 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668071Abrilada 40 MG per 0.8 ML Auto-InjectorSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668113Abrilada 40 MG per 0.8 ML InjectionSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668078Abrilada 40 MG per 0.8 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668106Abrilada 50 MG/ML per 0.2 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668096Abrilada 50 MG/ML per 0.4 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668071Abrilada 50 MG/ML per 0.8 ML Auto-InjectorSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668113Abrilada 50 MG/ML per 0.8 ML InjectionSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668078Abrilada 50 MG/ML per 0.8 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668105adalimumab-afzb 10 MG per 0.2 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668095adalimumab-afzb 20 MG per 0.4 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668064adalimumab-afzb 40 MG per 0.8 ML Auto-InjectorSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668109adalimumab-afzb 40 MG per 0.8 ML InjectionSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668074adalimumab-afzb 40 MG per 0.8 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668105adalimumab-afzb 50 MG/ML per 0.2 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668095adalimumab-afzb 50 MG/ML per 0.4 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668064adalimumab-afzb 50 MG/ML per 0.8 ML Auto-InjectorSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668109adalimumab-afzb 50 MG/ML per 0.8 ML InjectionSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
2668074adalimumab-afzb 50 MG/ML per 0.8 ML Prefilled SyringeSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
797544isopropyl alcohol 70 % Medicated PadSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
797544isopropyl alcohol 70 % Topical ClothSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8
797544isopropyl alcohol 70 % Topical SwabSY5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0025-0318-01000250318010.8 mL in 1 SYRINGE0.8 mlHistorical
0025-0325-01000250325011 KIT in 1 CARTON (0025-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) 1 kit2023-12-14NoNoCurrent
0025-0325-02000250325022 KIT in 1 CARTON (0025-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) 2 kit2023-12-14NoNoCurrent
0069-1111-01000691111011 mL in 1 PACKET1 mlHistorical