FDA.reportPublic FDA data

NDC 0004-0186-82 - Boniva

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
0004-0186
Requested NDC
0004-0186-82
Package NDCs from labels
0004-0186-83, 0004-0186-82
Manufacturer
Genentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche Ltd | F. Hoffmann-La Roche AG
Effective date
2021-11-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BonivaGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche Ltd | F. Hoffmann-La Roche AG2021-11-16HUMAN PRESCRIPTION DRUG LABEL
Boniva - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-12-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0186-82EA - Each0004-01867d36a8ea-ec42-4d0d-92c9-9d3ac91a6fbe12012-07-24
0004-0186-83EA - Each0004-018605c92b0e-b5e9-47c2-853a-e9cc6d6cf6dd12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibandronate sodiumACTIVE INGREDIENTJ12U072QL0BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
ibandronic acidACTIVE MOIETYUMD7G2653WBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
crospovidoneINACTIVE INGREDIENT68401960MKBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
povidone k25INACTIVE INGREDIENTK0KQV10C35BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
stearic acidINACTIVE INGREDIENT4ELV7Z65APBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
talcINACTIVE INGREDIENT7SEV7J4R1UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]22
IBANDRONATE SODIUMACTIVE INGREDIENTJ12U072QL0BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

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 9 of 144 · 2,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
unii: 15FIX9V2JP
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
unii: 15FIX9V2JP
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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