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 168 of 272 · 5,426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
unii: 3K9958V90M
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
unii: 3K9958V90M
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
unii: 3K9958V90M
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
unii: 3K9958V90M
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
unii: 3K9958V90M
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
unii: 3K9958V90M
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
unii: 3K9958V90M
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
meijer GINGERBREAD SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.1e1c8847-2d9e-43a6-9dd4-06c094c57c7b2025-03-28WarningsExact identifier
unii: 3K9958V90M
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.1cfcad5c-3896-3f69-e063-6294a90a8d9e2025-03-27WarningsExact identifier
unii: 3K9958V90M
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.1cfe0fba-69a0-6eb8-e063-6294a90a05822025-03-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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