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 246 of 269 · 5,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
knDR SANITIZERALCOHOLCROP BEAUTY GROUP INC.97f125d7-9ee9-4a0e-99e8-798df7ebb0ff2023-10-26WarningsExact identifier
unii: 3K9958V90M
Hibiscus ROSE HAND SANITIZERALCOHOLK7 Design Group Inc.a4e6c24d-731e-3ff9-e053-2995a90ae1f32023-10-26WarningsExact identifier
unii: 3K9958V90M
berry blast scent hand sanitizerALCOHOLK7 DESIGN GROUP INCffcfecbd-217f-41c8-9536-22c956de80f02023-10-26WarningsExact identifier
unii: 3K9958V90M
PARASOL SCENT-FREE HAND SANITIZERALCOHOLWe've Got Chemistry LLC84a9b4da-9b95-41cf-8453-876f79650e292023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Alcohol HandALCOHOLDesign International Group095af1a8-6966-4807-8724-84fec8d8045f2023-10-26WarningsExact identifier
unii: 3K9958V90M
BUBBLE GUM HAND SANITIZER boyALCOHOLK7 Design Group Inc.a4e669d2-5482-7c20-e053-2995a90ab0502023-10-26WarningsExact identifier
unii: 3K9958V90M
citrus crush scent hand sanitizer robotALCOHOLK7 DESIGN GROUP INC4753fd57-9868-4b02-aa8b-618241e1a9832023-10-26WarningsExact identifier
unii: 3K9958V90M
FINEAPPLE Hand SanitizerALCOHOLCROP BEAUTY GROUP INC.316625c6-dd73-485c-a617-ed86ebf2ac022023-10-26WarningsExact identifier
unii: 3K9958V90M
lemon lime scent hand sanitizerALCOHOLK7 DESIGN GROUP INC92415631-e00b-471d-9bca-5851777bcaa82023-10-26WarningsExact identifier
unii: 3K9958V90M
MELON DOLLAR Hand SanitizerALCOHOLCROP BEAUTY GROUP INC.32a974cd-3b2c-4120-b48f-31651ad7bc1a2023-10-26WarningsExact identifier
unii: 3K9958V90M
choco mallow melt hand sanitizerALCOHOLTarget Corporationeb483c27-ba83-4899-ae63-933467eec2862023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLBOZZANO Group948881d0-1740-47bd-9a49-d18e9e5532472023-10-26WarningsExact identifier
unii: 3K9958V90M
berry blitz hand sanitizerALCOHOLTarget Corporation2436a562-b7bb-4ff5-9f9f-fb98b3490c662023-10-26WarningsExact identifier
unii: 3K9958V90M
ANTI BACTERIAL HAND SANITIZERALCOHOLMiWorld Accesories LLCc107373c-6ff6-407c-ac38-17cfdd72b72b2023-10-26WarningsExact identifier
unii: 3K9958V90M
SFT1 Sanitizing WipesALCOHOLORR Safetyb787fa1d-1e15-245b-e053-2a95a90a00a12023-10-26WarningsExact identifier
unii: 3K9958V90M
PEPPERMINT TWIST HAND SANITIZERALCOHOLTarget Corporation3203ebbd-413b-4579-bd1d-798008c588aa2023-10-26WarningsExact identifier
unii: 3K9958V90M
COCONUT MACAROON HAND SANITIZERALCOHOLTarget Corporation2eb42750-fa10-47c3-8398-e1d5929528d52023-10-26WarningsExact identifier
unii: 3K9958V90M
SUGARED LEMON HAND SANITIZERALCOHOLTarget Corporationd0ef9002-de9d-4d9b-91a6-cc2f0553c8632023-10-26WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLORR Safety Corporationb2e133f6-87f4-4a01-96af-8941190f558c2023-10-26WarningsExact identifier
unii: 3K9958V90M
SPARKLING CRANBERRY HAND SANITIZERALCOHOLTarget Corporation7ca828e8-ff43-4e4c-8e8c-d760a0f0c2222023-10-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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