FDA.reportPublic FDA data

NDC 66993-418-82 - lansoprazole, amoxicillin and clarithromycin

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
66993-418
Requested NDC
66993-418-82
Package NDCs from labels
66993-418-82, 66993-418-64
Manufacturer
Prasco Laboratories | Takeda Pharmaceuticals America, Inc
Effective date
2018-12-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
lansoprazole - Prasco Laboratories | Takeda Pharmaceuticals America, IncPrasco Laboratories | Takeda Pharmaceuticals America, Inc2018-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-418-64EA - Each66993-418bf6ee281-c672-41ac-83d2-d147ebafd02d12015-04-03
66993-418-82EA - Each66993-4185a37cd6f-fe1f-4cef-ace0-272d332d357612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amoxicillinACTIVE INGREDIENT804826J2HULANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
clarithromycinACTIVE INGREDIENTH1250JIK0ALANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
clarithromycinACTIVE MOIETYH1250JIK0ALANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
magnesium stearateINACTIVE INGREDIENT70097M6I30LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
methacrylic acid - ethyl acrylate copolymer (1:1) type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
sorbic acidINACTIVE INGREDIENTX045WJ989BLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]2
vanillinINACTIVE INGREDIENTCHI530446XLANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [PRASCO LABORATORIES]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 1 of 355 · 7,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLINAMOXICILLINREMEDYREPACK INC.4adc198e-39d8-4b3e-bfa4-278aaf4064ae2026-09-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
unii: ND2M416302
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: ND2M416302
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
unii: ND2M416302
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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