FDA.reportPublic FDA data

NDC 49702-238 - Cabenuva

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49702-238
Package NDCs from labels
49702-238-01, 49702-238-64, 49702-238-03, 49702-238-61
Manufacturer
ViiV Healthcare Company | Glaxo Wellcome Manufacturing Pte. Ltd | Janssen Pharmaceutica NV
Effective date
2025-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cabenuva - ViiV Healthcare Company | Glaxo Wellcome Manufacturing Pte. Ltd | Janssen Pharmaceutica NVViiV Healthcare Company | Glaxo Wellcome Manufacturing Pte. Ltd | Janssen Pharmaceutica NV2025-11-26HUMAN PRESCRIPTION DRUG LABEL
Apretude - ViiV Healthcare CompanyViiV Healthcare Company2025-04-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-238-01Cabenuva3 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED1 mL200 mg in 1mL16
49702-238-64Cabenuva3 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED1 mL200 mg in 1mL16
49702-238-03Apretude3 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED3 mL200 mg in 1mL8
49702-238-61Apretude3 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED3 mL200 mg in 1mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-238CABENUVA (CABOTEGRAVIR AND RILPIVIRINE) KIT [VIIV HEALTHCARE COMPANY]14Unmatched20250416_1698baf3-f895-4c42-a1b1-e9ee3f20da36.zip
49702-238APRETUDE (CABOTEGRAVIR) KIT [VIIV HEALTHCARE COMPANY]8Unmatched20250419_4338428e-43d4-4e02-ac9d-bd98e738a7da.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 7 of 24 · 468 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: LX22YL083G
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: LX22YL083G
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: LX22YL083G
unii: 593YOG76RN
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
unii: LX22YL083G
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350ANI Pharmaceuticals, Inc.1afff730-b2d3-4e01-8403-97f2ecef3a742025-12-10WarningsExact identifier
unii: G2M7P15E5P
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
unii: G2M7P15E5P
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
unii: G2M7P15E5P
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsExact identifier
unii: G2M7P15E5P
CabenuvaCABOTEGRAVIR AND RILPIVIRINEViiV Healthcare Company1698baf3-f895-4c42-a1b1-e9ee3f20da362025-11-26Warnings, Adverse reactionsExact identifier
application number: NDA212888
ndc (package): 49702-249-02
ndc (package): 49702-266-63
ndc (package): 49702-238-01
ndc (package): 49702-245-01
ndc (package): 49702-253-15
ndc (package): 49702-243-61
ndc (package): 49702-243-02
ndc (package): 49702-240-15
ndc (package): 49702-238-64
ndc (product): 49702-240
ndc (product): 49702-266
ndc (product): 49702-253
rxcui: 2475418
rxcui: 2594980
rxcui: 2588077
rxcui: 2475416
rxcui: 2475417
rxcui: 2594982
rxcui: 2594978
rxcui: 2475415
spl id: 15253b2a-c96c-489c-be6d-b37fcb63ad5b
spl set id: 1698baf3-f895-4c42-a1b1-e9ee3f20da36

Reported adverse events (FAERS/openFDA)#

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