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 196 of 271 · 5,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
unii: 15FIX9V2JP
PURELL Healthcare Advanced Hand Sanitizer GelALCOHOLGOJO Industries, Inc.e3eef311-7515-46e8-8643-ead7905961842024-12-11WarningsExact identifier
unii: 3K9958V90M
Purell Advanced Moisturizing 2in1ALCOHOLGOJO Industries, Inc.950002ed-f3a2-4ede-98fe-762ee9f018b92024-12-11WarningsExact identifier
unii: 3K9958V90M
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep HoneyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdc792777-d8b6-3ebc-e053-2a95a90abc3f2024-12-11WarningsExact identifier
unii: 15FIX9V2JP
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsExact identifier
unii: 3K9958V90M
PURELL Healthcare Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.4fa85619-257f-4a19-a8f2-5a2e4b8097262024-12-11WarningsExact identifier
unii: 3K9958V90M
ZOEY naturals Island Hibiscus HAND SANITIZERETHYL ALCOHOLAbsolutely Natural, Inc.2829dec2-1425-4ac3-812b-f45abd7ec4262024-12-11WarningsExact identifier
unii: 3K9958V90M
Absolutely Natural Cherry Blossom Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.f825e0bf-495f-4bfa-a6e0-5ddbefb37f522024-12-11WarningsExact identifier
unii: 3K9958V90M
Absolutely Natural Rosemary and Mint Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.a7be8b58-8f3e-46ed-ae4d-45f093c98dc32024-12-11WarningsExact identifier
unii: 3K9958V90M
ZOEY naturals English Garden HAND SANITIZERETHYL ALCOHOLAbsolutely Natural0c7d0d85-b919-4f47-9888-1ccc91054edf2024-12-11WarningsExact identifier
unii: 3K9958V90M
Zoey Naturals Lemon Squeeze Hand SanitizerETHYL ALCOHOLAbsolutely Natural, Inc.c119069c-092e-49ca-8f89-11fb75c768402024-12-11WarningsExact identifier
unii: 3K9958V90M
MELLOW HAND SANITIZER ALOEETHYL ALCOHOLL.e.d. Cosmetics, Inc.4377ba5e-21f6-407e-9b8c-25e3c6321a5b2024-12-10WarningsExact identifier
unii: 3K9958V90M
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
unii: 15FIX9V2JP
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsExact identifier
unii: 3K9958V90M
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.4065c34c-d1ca-49bd-9fba-dfa21011592f2024-12-10WarningsExact identifier
unii: 3K9958V90M
QUALITY CHOICE INSTANT HAND SANITIZERETHYL ALCOHOLL.e.d. Cosmetics, Inc.ec37da5a-8ef7-474b-a5ec-b5edcee03f9d2024-12-10WarningsExact identifier
unii: 3K9958V90M
CSI E3 Hand SanitizerALCOHOLCentral Solutions Incaa07bb62-ef07-99e4-e053-2995a90ae4a82024-12-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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