CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

Candesartan Cilexetil and Hydrochlorothiazide by

Drug Labeling and Warnings

Candesartan Cilexetil and Hydrochlorothiazide by is a Prescription medication manufactured, distributed, or labeled by ANI Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hypotension

Candesartan cilexetil and hydrochlorothiazide tablets can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Patients with symptomatic hypotension may require temporarily reducing the dose of candesartan cilexetil and hydrochlorothiazide tablets or volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with candesartan cilexetil and hydrochlorothiazide tablets.

In patients with heart failure, candesartan cilexetil and hydrochlorothiazide tablets may cause excessive hypotension, which may lead to oliguria, azotemia, and (rarely) with acute renal failure and death (see WARNINGS, Impaired Renal Function). In such patients, candesartan cilexetil and hydrochlorothiazide tablets therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of candesartan or diuretic is increased.

Impaired Renal Function

Monitor renal function periodically in patients treated with candesartan cilexetil and hydrochlorothiazide tablets. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on candesartan cilexetil and hydrochlorothiazide tablets. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on candesartan cilexetil and hydrochlorothiazide tablets.

Potassium Abnormalities

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia, which appears difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

In clinical trials of various doses of candesartan cilexetil and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 2.5% versus 2.1% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4% versus 1.0% for placebo. No patient receiving candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg or 32 mg/12.5 mg was discontinued due to increases or decreases in serum potassium.

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

  • PRECAUTIONS

    Metabolic Disturbances

    Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

    Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

    Thiazides decrease urinary calcium excretion and may cause elevation of serum calcium. Avoid using candesartan cilexetil and hydrochlorothiazide tablets in patients with hypercalcemia.

    Systemic Lupus Erythematosus

    Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

    Information for Patients

    Pregnancy

    Female patients of childbearing age should be told about the consequences of exposure to candesartan cilexetil and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

    Symptomatic Hypotension

    Tell patients receiving candesartan cilexetil and hydrochlorothiazide tablets that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, discontinue candesartan cilexetil and hydrochlorothiazide tablets until the physician has been consulted.

    Tell all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

    Hyperkalemia

    Tell patients receiving candesartan cilexetil and hydrochlorothiazide tablets not to use potassium supplements, salt substitutes containing potassium, or other drugs that may increase serum potassium levels without consulting the prescribing physician.

    Drug Interactions

    Because candesartan is not significantly metabolized by the cytochrome P450 system and at therapeutic concentrations has no effects on P450 enzymes, interactions with drugs that inhibit or are metabolized by those enzymes would not be expected.

    Interactions common to both Candesartan Cilexetil and Hydrochlorothiazide

    Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

    In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including candesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving candesartan and NSAID therapy.

    The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

    Lithium

    Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use.

    Interactions with Candesartan Cilexetil

    Dual Blockade of the Renin-Angiotensin System (RAS)

    Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on candesartan cilexetil and hydrochlorothiazide tablets and other agents that affect the RAS.

    Co-administration of candesartan cilexetil and hydrochlorothiazide tablets with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

    Do not co-administer aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with diabetes. Avoid use of aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/min) (see CONTRAINDICATIONS).

    Interactions with Hydrochlorothiazide

    Alcohol, barbiturates, or narcotics − Potentiation of orthostatic hypotension may occur.

    Antidiabetic drugs (oral agents and insulin) − Dosage adjustment of the antidiabetic drug may be required.

    Diazoxide − the hyperglycemic effect of diazoxide may be enhanced by thiazides.

    Ion Exchange resins − Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Stagger the dosage of hydrochlorothiazide and ion exchange resins such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins.

    Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) − Possible increased responsiveness to muscle relaxants such as curare derivatives.

    Digitalis − Thiazide-induced hypokalemia or hypomagnesemia may predispose to digoxin toxicity.

    Noradrenaline – Thiazides may decrease arterial responsiveness to noradrenaline, but not enough to preclude effectiveness of the pressor agent for therapeutic use.

    Steroids or Adrenocorticotropic Hormone – Hypokalemia may develop during concomitant use of steroids or adrenocorticotropic hormone (ACTH).

    Cytotoxic products – Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

    Cyclosporine − Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No carcinogenicity studies have been conducted with the combination of candesartan cilexetil and hydrochlorothiazide. There was no evidence of carcinogenicity when candesartan cilexetil was orally administered to mice and rats for up to 104 weeks at doses up to 100 and 1000 mg/kg/day, respectively. Rats received the drug by gavage whereas mice received the drug by dietary administration. These (maximally-tolerated) doses of candesartan cilexetil provided systemic exposures to candesartan (AUCs) that were, in mice, approximately 7 times and, in rats, more than 70 times the exposure in man at the maximum recommended daily human dose (32 mg). Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

    Candesartan cilexetil or candesartan (the active metabolite), in combination with hydrochlorothiazide, tested positive in vitro in the Chinese hamster lung (CHL) chromosomal aberration assay and mouse lymphoma mutagenicity assay. The candesartan cilexetil/hydrochlorothiazide combination tested negative for mutagenicity in bacteria (Ames test), for unscheduled DNA synthesis in rat liver, for chromosomal aberrations in rat bone marrow and for micronuclei in mouse bone marrow.

    Both candesartan and its O-deethyl metabolite tested positive for genotoxicity in the in vitro CHL chromosomal aberration assay. Neither compound tested positive in the Ames microbial mutagenesis assay or in the in vitro mouse lymphoma cell assay. Candesartan (but not its O-deethyl metabolite) was also evaluated in vivo in the mouse micronucleus test and in vitro in the Chinese hamster ovary (CHO) gene mutation assay, in both cases with negative results. Candesartan cilexetil was evaluated in the Ames test, the in vitro mouse lymphoma cell assay, the in vivo rat hepatocyte unscheduled DNA synthesis assay and the in vivo mouse micronucleus test, in each case with negative results. Candesartan cilexetil was not evaluated in the CHL chromosomal aberration or CHO gene mutation assays.

    When hydrochlorothiazide was tested alone, positive results were obtained in vitro in the CHO sister chromatid exchange (clastogenicity) and mouse lymphoma cell (mutagenicity) assays and in the Aspergillus nidulans non-disjunction assay. Hydrochlorothiazide was not genotoxic in vitro in the Ames test for point mutations and the CHO test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

    No fertility studies have been conducted with the combination of candesartan cilexetil and hydrochlorothiazide. Fertility and reproductive performance were not affected in studies with male and female rats given oral doses of up to 300 mg candesartan cilexetil/kg/day (83 times the maximum daily human dose of 32 mg on a body surface area basis). Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.

    Nursing Mothers

    It is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    Neonates with a history of in utero exposure to candesartan cilexetil and hydrochlorothiazide tablets:

    If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

    Safety and effectiveness in pediatric patients have not been established.

  • ADVERSE REACTIONS

    Candesartan Cilexetil and Hydrochlorothiazide

    Candesartan cilexetil and hydrochlorothiazide tablets have been evaluated for safety in more than 2800 patients treated for hypertension. More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse events reported with candesartan cilexetil and hydrochlorothiazide tablets was comparable to placebo. The overall frequency of adverse experiences was not related to dose, age, gender, or race.

    In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses of 2-32 mg) and hydrochlorothiazide (doses of 6.25-25 mg) and 592 patients treated with placebo, adverse events, whether or not attributed to treatment, occurring in greater than 2% of patients treated with candesartan cilexetil and hydrochlorothiazide tablets and that were more frequent for candesartan cilexetil and hydrochlorothiazide tablets than placebo were: Respiratory System Disorder: upper respiratory tract infection (3.6% vs 3.0%); Body as a Whole: back pain (3.3% vs 2.4%); influenza-like symptoms (2.5% vs 1.9%); Central/Peripheral Nervous System: dizziness (2.9% vs 1.2%).

    Post-Marketing Experience

    The following have been very rarely reported in post-marketing experience with candesartan cilexetil:

    Digestive: Abnormal hepatic function and hepatitis.

    Hematologic: Neutropenia, leukopenia, and agranulocytosis.

    Immunologic: Angioedema

    Metabolic and Nutritional Disorders: Hyperkalemia, hyponatremia.

    Respiratory System Disorders: Cough

    Skin and Appendages Disorders: Pruritus, rash and urticaria.

    Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

    Hydrochlorothiazide

    Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

    Gastrointestinal: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, anorexia

    Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

    Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, urticaria, purpura

    Musculoskeletal: muscle spasm

    Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia

    Special Senses: transient blurred vision, xanthopsia

    Urogenital: impotence

  • OVERDOSAGE

    Candesartan Cilexetil and Hydrochlorothiazide

    No lethality was observed in acute toxicity studies in mice, rats and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil or in rats given single oral doses of up to 2000 mg/kg of candesartan cilexetil in combination with 1000 mg/kg of hydrochlorothiazide. In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg.

    Limited data are available in regard to overdosage with candesartan cilexetil in humans. The most likely manifestations of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be initiated. For hydrochlorothiazide, the most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

    Candesartan cannot be removed by hemodialysis. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

    Treatment

    To obtain up-to-date information about the treatment of overdose, consult your Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient.

  • DOSAGE AND ADMINISTRATION

    The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

    Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

    Use in Renal Impairment: Dosing recommendations for candesartan cilexetil and hydrochlorothiazide tablets in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

    Use in moderate to severe Hepatic Impairment: Candesartan cilexetil and hydrochlorothiazide tablets are not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency).

    Replacement Therapy: The combination may be substituted for the titrated components.

    Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg and serum potassium may improve.

    A patient whose blood pressure is not controlled on 32 mg of candesartan cilexetil tablets can expect incremental blood pressure effects from candesartan cilexetil and hydrochlorothiazide tablets 32 mg/12.5 mg and then 32 mg/25 mg. The maximal antihypertensive effect of any dose of candesartan cilexetil and hydrochlorothiazide tablets can be expected within 4 weeks of initiating that dose.

    Candesartan cilexetil and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

    Candesartan cilexetil and hydrochlorothiazide tablets may be administered with or without food.

  • HOW SUPPLIED

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied in bottles of 90 tablets (NDC: 62559-660-90).

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied in bottles of 90 tablets (NDC: 62559-661-90).

    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are pink, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACD on one side. They are supplied in bottles of 90 tablets (NDC: 62559-662-90).

    Storage:

    Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

    Manufactured under the license from Takeda Pharmaceutical Company, Ltd.

    Manufactured by:
    AstraZeneca AB, SE-151 85
    Södertälje, Sweden

    Distributed by:
    ANI Pharmaceuticals, Inc.
    Baudette, MN 56623
    logo

    10118 Rev 05/18

  • PRINCIPAL DISPLAY PANEL – 16 mg/12.5 mg

    NDC: 62559-660-90
    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP
    16 mg/12.5 mg
    Rx only
    90 Tablets
    Label_16-12

  • PRINCIPAL DISPLAY PANEL – 32 mg/12.5 mg

    NDC: 62559-661-90
    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP
    32 mg/12.5 mg
    Rx only
    90 Tablets
    Label_32-12

  • PRINCIPAL DISPLAY PANEL – 32 mg/25 mg

    NDC: 62559-662-90
    Candesartan Cilexetil and Hydrochlorothiazide Tablets USP
    32 mg/25 mg
    Rx only
    90 Tablets
    Label_32-25

  • INGREDIENTS AND APPEARANCE
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62559-660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL16 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorPINK (peach) Score2 pieces
    ShapeOVAL (biconvex) Size10mm
    FlavorImprint Code ACS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62559-660-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02109309/26/2018
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62559-661
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeOVAL (biconvex) Size11mm
    FlavorImprint Code ACJ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62559-661-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02109309/26/2018
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
    candesartan cilexetil and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62559-662
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeOVAL (biconvex) Size11mm
    FlavorImprint Code ACD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62559-662-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02109309/26/2018
    Labeler - ANI Pharmaceuticals, Inc. (145588013)
    Registrant - ANI Pharmaceuticals, Inc. (145588013)

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