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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2668064Internal RxNorm lookup
2668071Internal RxNorm lookup
2668074Internal RxNorm lookup
2668078Internal RxNorm lookup
2668095Internal RxNorm lookup
2668096Internal RxNorm lookup
2668105Internal RxNorm lookup
2668106Internal RxNorm lookup
2668109Internal RxNorm lookup
2668113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4fAvailable on FDA.report

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions1602cfaf-9ddd-4eb6-b847-10a4eebcf5e52026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions79943fe6-1249-4074-9aed-c53937820d0f2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761118
ndc (product): 0025-0325

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761118Abriladaadalimumab-afzb351(k) InterchangeableRx2026-09-01

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