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 264 of 269 · 5,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA BOWEL PLUSACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE -Guna spab3aa4fd3-c87a-ccd2-e053-2995a90a46a92021-01-17WarningsExact identifier
unii: 45P3261C7T
Real ReliefAPIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUMGMP Laboratories of America, Inc.b7a1ce34-a996-22cf-e053-2a95a90afa452020-12-29WarningsExact identifier
unii: 45P3261C7T
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.997474d5-4dc4-6104-e053-2995a90a03f12020-12-07WarningsExact identifier
unii: ETJ7Z6XBU4
IntestiaECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUMNewton Laboratories, Inc.9a132c99-7278-f667-e053-2a95a90a3d2b2020-12-04WarningsExact identifier
unii: 45P3261C7T
Lymphatic DrainerECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9a633bfa-188c-dd42-e053-2995a90ad3aa2020-12-04WarningsExact identifier
unii: 45P3261C7T
Oral Care-GingivitisACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEANewton Laboratories, Inc.9971a7f4-c02c-02ba-e053-2a95a90a2b732020-12-04WarningsExact identifier
unii: ETJ7Z6XBU4
EdemaELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.Newton Laboratories, Inc.98fbd4b0-43ac-098b-e053-2a95a90a66452020-12-03WarningsExact identifier
unii: 45P3261C7T
Female FemroidsHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS.Newton Laboratories, Inc.9a01acb9-1b2b-3a33-e053-2995a90adc922020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b59731a2-c775-7e8a-e053-2a95a90a90622020-12-03WarningsExact identifier
unii: ETJ7Z6XBU4
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Appetite - Craving ControlCHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUMNewton Laboratories, Inc.98cf5293-2a47-5e15-e053-2995a90a9c3b2020-12-02WarningsExact identifier
unii: 45P3261C7T
Breast Care - FibrocysticBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.98d01128-9887-12ce-e053-2a95a90a73292020-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Connec-TECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS.Newton Laboratories, Inc.9a630923-1497-1fc8-e053-2995a90ad0012020-12-02WarningsExact identifier
unii: 45P3261C7T
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d0be75-9b50-1e15-e053-2995a90abf3b2020-12-02WarningsExact identifier
unii: 45P3261C7T
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d08917-2f1b-4dc7-e053-2a95a90a1ce02020-12-02WarningsExact identifier
unii: 45P3261C7T
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b56f2ffc-4637-1f23-e053-2a95a90aa3af2020-12-01WarningsExact identifier
unii: ETJ7Z6XBU4
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: ETJ7Z6XBU4
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798c853c-16ab-8502-e053-2a91aa0a65322020-11-24WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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