FDA.reportPublic FDA data

NDC 68084-021-11 - Abacavir

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
68084-021
Requested NDC
68084-021-11
Package NDCs from labels
68084-021-11, 68084-021-21
Manufacturer
American Health Packaging
Effective date
2024-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Abacavir - American Health PackagingAmerican Health Packaging2024-08-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-021-11Abacavir1 in 1 BLISTER PACKTABLET, FILM COATED17
68084-021-21Abacavir30 in 1 BOX, UNIT-DOSETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-021ABACAVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240802_01e46f58-8bda-4ff3-ab21-57d5b540d440.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-021-11EA - Each68084-021e550e594-ca73-4336-8724-6dae20139b2412013-03-03
68084-021-21EA - Each68084-021a74a863e-4d00-4ce4-8b08-aacc0a46804012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

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 39 of 130 · 2,585 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
unii: 15FIX9V2JP
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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