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 65 of 275 · 5,488 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
unii: 3K9958V90M
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
unii: 3K9958V90M
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
unii: 3K9958V90M
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIb63d9c12-8471-4db5-998b-ab46184495372026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUnited Natural Foods, Inc. dba UNFIccf505f6-2b34-4a18-af07-92ed505644ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUline8ed759a2-fb0e-474e-8245-ddb798e542ff2026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUline3bc9cfa2-2b1f-4892-93ff-cffa9f5878042026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUlinefdda41fa-d847-4cee-a070-91f0600b0fc82026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel The Upside DownALCOHOLBath & Body Works, Inc.29a539bb-42e7-dc73-e063-6394a90a5fe92026-02-17WarningsExact identifier
unii: 3K9958V90M
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.38d661c8-6f48-f58c-e063-6294a90ae8c12026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.38951f0d-0ec4-2406-e063-6394a90a9fe32026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38d656e3-5f8f-9874-e063-6394a90a8ea52026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus MintALCOHOLBath & Body Works, Inc.38d65eae-f1af-f342-e063-6294a90af7fe2026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer OCEAN BREEZE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2cf4bc63-6157-4c4f-bb52-aa685f8d4aee2026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO15a5272c-0abc-47e1-be21-91a601ead3082026-02-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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