FDA.reportPublic FDA data

Cabenuva

Product NDC
49702-253
11-digit product format
497020253
Labeler code
49702
Product ID
49702-253_15253b2a-c96c-489c-be6d-b37fcb63ad5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cabotegravir and rilpivirine
Dosage form
KIT
Labeler
ViiV Healthcare Company
Application
NDA212888
Marketing category
NDA
Marketing start
2021-01-21
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cabenuva
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2475415, 2475416, 2475417, 2475418, 2588077, 2594978, 2594980, 2594982

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
38d19fab-47e8-d825-5329-4948eaa6d686Product name220250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ba89f589-ed67-48fe-9931-d0915055348aProduct name120220728
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dc78e92e-f760-407c-94a4-da4867af6b2bProduct name120210204
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
44633898-5724-4273-abcc-3541a1107946Product name120180124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-245-01Cabenuva2 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED1 mL200 mg in 1mL16
49702-249-02Cabenuva2 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED1 mL300 mg in 1mL16
49702-253-15Cabenuva1 in 1 CARTONKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-253-15ML - Milliliter49702-2533105582b-c1c7-4f8a-8030-49abb2b1305e12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-253CABENUVA (CABOTEGRAVIR AND RILPIVIRINE) KIT [VIIV HEALTHCARE COMPANY]14Current NDC, Legacy NDC, 3 package rows20250416_1698baf3-f895-4c42-a1b1-e9ee3f20da36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475418{1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 400 MG / 600 MG]BPCK1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475416{1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 600 MG / 900 MG]BPCK1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475417{1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } PackGPCK1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475415{1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } PackGPCK1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475418CABENUVA 400 MG / 600 MG Extended Release KitPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475416CABENUVA 600 MG / 900 MG Extended Release KitPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475417cabotegravir 400 MG / rilpivirine 600 MG Extended Release KitPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594978cabotegravir 400 MG in 2 ML Extended Release InjectionPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475415cabotegravir 600 MG / rilpivirine 900 MG Extended Release KitPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2588077cabotegravir 600 MG in 3 ML Extended Release InjectionPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594982rilpivirine 600 MG in 2 ML Extended Release InjectionPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594980rilpivirine 900 MG in 3 ML Extended Release InjectionPSN1698baf3-f895-4c42-a1b1-e9ee3f20da3616
25949782 ML cabotegravir 200 MG/ML InjectionSCD1698baf3-f895-4c42-a1b1-e9ee3f20da3616
25949822 ML rilpivirine 300 MG/ML InjectionSCD1698baf3-f895-4c42-a1b1-e9ee3f20da3616
25880773 ML cabotegravir 200 MG/ML InjectionSCD1698baf3-f895-4c42-a1b1-e9ee3f20da3616
25949803 ML rilpivirine 300 MG/ML InjectionSCD1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475418CABENUVA 400 MG / 600 MG Extended Release KitSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475416CABENUVA 600 MG / 900 MG Extended Release KitSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475417cabotegravir 400 MG / rilpivirine 600 MG Extended Release KitSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594978cabotegravir 400 MG per 2 ML InjectionSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2475415cabotegravir 600 MG / rilpivirine 900 MG Extended Release KitSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2588077cabotegravir 600 MG per 3 ML InjectionSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594982rilpivirine 600 MG per 2 ML InjectionSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616
2594980rilpivirine 900 MG per 3 ML InjectionSY1698baf3-f895-4c42-a1b1-e9ee3f20da3616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49702-245-01497020245012 mL in 1 VIAL2 mlHistorical
49702-249-02497020249022 mL in 1 VIAL2 mlHistorical
49702-253-15497020253151 KIT in 1 CARTON (49702-253-15) * 2 mL in 1 VIAL (49702-245-01) * 2 mL in 1 VIAL (49702-249-02) 1 kit2021-01-210000-00-00NoNoCurrent