FDA.reportPublic FDA data

NDC 68180-784-01 - OMEPRAZOLE

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
68180-784
Requested NDC
68180-784-01
Package NDCs from labels
68180-784-06, 68180-784-01, 68180-784-03
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2019-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OMEPRAZOLE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2019-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-784-01OMEPRAZOLE100 in 1 BOTTLECAPSULE, DELAYED RELEASE1008
68180-784-03OMEPRAZOLE1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10008
68180-784-06OMEPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-784OMEPRAZOLE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]83 package rows20240101_be061124-0aa9-4bf5-ae58-adf8c3ed4204.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 127 of 128 · 2,546 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TawnyZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc94d604d4-b0bf-4f3e-888c-b6104241925b2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CocoaZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc9f6a5740-174c-4244-b291-6ab6367ce5122017-12-05WarningsExact identifier
unii: 15FIX9V2JP
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Sleep Well T012ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISGuangzhou Renuma Medical Systems Co., Ltd2dc9026a-b847-403b-a92e-5d629e4b3c682017-10-24WarningsExact identifier
unii: 0E53J927NA
Test FlexAVENA SATIVA, CALCAREA CARBONICA, DAMIANA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, MAGNESIA CARBONICA, MILLEFOLIUM, SABAL SERRULATA, THUJA OCCIDENTALIS, URTICA URENSSafe Anabolic Sciencesfed38357-f3b7-42f0-9367-eaf97e15c0592017-08-17WarningsExact identifier
unii: 0E53J927NA
Age Renewal Firming and Hydrating Moisturizer SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDECVS Health5f6f677d-2404-4e56-a48f-4263314afd9b2017-03-14WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20Mana Productsae6a86d2-a95b-4fa8-9676-233ef9fdc3b02017-02-22WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENCVS Pharmacy, Inc7795e651-838e-41f8-b48d-bd2e0dd1beec2017-01-18WarningsExact identifier
unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30Mana Productscec89a7e-1670-4d3c-b48c-28ed1ea7f9572016-12-07WarningsExact identifier
unii: 15FIX9V2JP
Age Renewal FirmingOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAMCOL Health & Beauty Solutions, Inc. DBA6cb27f87-40a3-4049-aded-eb788509c5752016-10-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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