NDC 65697-450 - Clanza CR

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
65697-450
Package NDCs from labels
65697-450-20, 65697-450-21, 65697-450-22
Manufacturer
United Douglas Pharm., Inc. | Korea United Pharm Inc.
Effective date
2011-11-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clanza CR - United Douglas Pharm., Inc. | Korea United Pharm Inc.United Douglas Pharm., Inc. | Korea United Pharm Inc.2011-11-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65697-450-202019-11-13C16284748780-197449f38-bb73-f6ea-e053-dbdaa90aa7038a023942-01e8-4849-aa3c-1a640ffc7fd3
65697-450-222019-11-13C16284748780-197449f38-bb73-f6ea-e053-dbdaa90aa7038a023942-01e8-4849-aa3c-1a640ffc7fd3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65697-450-20ClanzaCR1 in 1 PACKETTABLET, FILM COATED17
65697-450-21ClanzaCR10 in 1 BLISTER PACKTABLET, FILM COATED107
65697-450-22ClanzaCR10 in 1 CARTONTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65697-450CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]73 package rows20111103_8a023942-01e8-4849-aa3c-1a640ffc7fd3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AceclofenacACTIVE INGREDIENTRPK779R03HCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
AceclofenacACTIVE MOIETYRPK779R03HCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
AlcoholINACTIVE INGREDIENT3K9958V90MCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Carbomer 941INACTIVE INGREDIENTF68VH75CJCCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
CrospovidoneINACTIVE INGREDIENT68401960MKCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Diethyl PhthalateINACTIVE INGREDIENTUF064M00AFCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Methylene ChlorideINACTIVE INGREDIENT588X2YUY0ACLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Sodium CarbonateINACTIVE INGREDIENT45P3261C7TCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7

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 183 of 271 · 5,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Fresh BalsamALCOHOLBath & Body Works, Inc.2b0f3ca1-0a64-08a6-e063-6294a90a9df22025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Perfect in PinkALCOHOLBath & Body Works, Inc.2b0f4b8f-b046-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.2b0f4b8f-b041-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowy Peach BerryALCOHOLBath & Body Works, Inc.2b0f466b-8e08-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne In ParisALCOHOLBath & Body Works, Inc.2b0f525b-ff63-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender LuxeALCOHOLBath & Body Works, Inc.2b0f466b-8e0c-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cookie Butter TruffleALCOHOLBath & Body Works, Inc.2b0f525b-ff60-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bright Christmas MorningALCOHOLBath & Body Works, Inc.2b0f4b8f-b042-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla IciclesALCOHOLBath & Body Works, Inc.2b0f3f65-746f-44ea-e063-6294a90a91852025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bubbly RoseALCOHOLBath & Body Works, Inc.2b1164fb-f6d5-5962-e063-6294a90a72972025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Macaron CloudALCOHOLBath & Body Works, Inc.2b115325-4268-5687-e063-6294a90ac6f82025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Party DressALCOHOLBath & Body Works, Inc.2b1171f1-f4b2-ce4b-e063-6394a90a7c822025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White Oak and VanillaALCOHOLBath & Body Works, Inc.2b11647a-ed9c-1c26-e063-6394a90a29b92025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Coconut Mint DropALCOHOLBath & Body Works, Inc.2b1132db-93f1-f73a-e063-6294a90a1e6f2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cranberry Pear BelliniALCOHOLBath & Body Works, Inc.2b113330-d619-ef15-e063-6394a90ac3fe2025-01-06WarningsExact identifier
unii: 3K9958V90M
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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