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 208 of 271 · 5,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS HEALTH CONTINUOUS HAND SANITIZERALCOHOLCVS PHARMACYc89a28ac-ab53-46dd-e053-2a95a90a32842024-10-22WarningsExact identifier
unii: 3K9958V90M
TRADER JOES HAND SANITIZER LAVENDERETHYL ALCOHOLTrader Joe's Company4d782831-dab8-4553-9786-b5172813553e2024-10-22WarningsExact identifier
unii: 3K9958V90M
TRADER JOES HAND SANITIZER GRAPEFRUIT LEMONALCOHOLTrader Joe's Companyf4c1e80a-847b-4407-92b7-570c032bea602024-10-22WarningsExact identifier
unii: 3K9958V90M
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
unii: 15FIX9V2JP
HAND SANITIZER RAINFALLALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b6-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER RASPBERRY MANGOALCOHOLSCENT THEORY PRODUCTS LLC24b19489-4e59-0df8-e063-6394a90af6ae2024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER BRAZILIAN COCONUTALCOHOLSCENT THEORY PRODUCTS LLC24b1992a-d695-32b2-e063-6394a90a6cab2024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER LUSH ALOEALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b8-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
unii: 3K9958V90M
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
unii: 15FIX9V2JP
HAND SANITIZER SANDALWOOD WAVESALCOHOLSCENT THEORY PRODUCTS LLC24893800-464a-16ca-e063-6294a90a90652024-10-16WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZERINSTANT HAND SANITIZERRainbow Technology Corporation249d50e1-da31-1975-e063-6294a90afc842024-10-16WarningsExact identifier
unii: 3K9958V90M
ProGel Max Hand SanitizerALCOHOLDelta Pharma Inc.a607897c-c398-1931-e053-2a95a90ae4832024-10-16WarningsExact identifier
unii: 3K9958V90M
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
unii: 15FIX9V2JP
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Antiseptic Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af08c1f3-b1c4-58aa-e053-2a95a90ab3202024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af8466d7-794a-cb95-e053-2a95a90a6ffc2024-10-15WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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