{
"NDC": [
{
"NDCCode": "42806-147-31",
"PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (42806-147-31) ",
"NDC11Code": "42806-0147-31",
"ProductNDC": "42806-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207531",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color."
},
{
"NDCCode": "58411-147-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-147-60) > 31.25 g in 1 TUBE",
"NDC11Code": "58411-0147-60",
"ProductNDC": "58411-147",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Foundation L",
"ProprietaryNameSuffix": "O10",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "656",
"StrengthUnit": "mg/31.25g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140201",
"SamplePackage": "N"
},
{
"NDCCode": "67777-147-30",
"PackageDescription": "24 TUBE in 1 CASE (67777-147-30) / 106 g in 1 TUBE (67777-147-31) ",
"NDC11Code": "67777-0147-30",
"ProductNDC": "67777-147",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D-cerin",
"NonProprietaryName": "Moisturizer",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "33",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180820",
"SamplePackage": "N",
"IndicationAndUsage": " Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather."
},
{
"NDCCode": "42806-049-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-049-01) ",
"NDC11Code": "42806-0049-01",
"ProductNDC": "42806-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074673",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131202",
"EndMarketingDatePackage": "20180731",
"SamplePackage": "N"
},
{
"NDCCode": "42806-049-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42806-049-05) ",
"NDC11Code": "42806-0049-05",
"ProductNDC": "42806-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074673",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131202",
"EndMarketingDatePackage": "20180731",
"SamplePackage": "N"
},
{
"NDCCode": "0409-4196-05",
"PackageDescription": "6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-4196-05",
"ProductNDC": "0409-4196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Potassium Acetate, Phosphoric Acid, And Magnesium Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017789",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; POTASSIUM ACETATE; PHOSPHORIC ACID; MAGNESIUM ACETATE",
"StrengthNumber": "252; 329; 252; 140; 154; 182; 56; 280; 448; 343; 105; 300; 147; 31; 448; 234; 128; 40; 21",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11523-7368-1",
"PackageDescription": "147 mL in 1 BOTTLE, PLASTIC (11523-7368-1)",
"NDC11Code": "11523-7368-01",
"ProductNDC": "11523-7368",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Clearly Sheer For Beach And Pool",
"ProprietaryNameSuffix": "Spf 50 Plus",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "MSD Consumer Care, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "31.02; 103.4; 47.05; 93.06; 51.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "11523-7391-1",
"PackageDescription": "147 mL in 1 BOTTLE, PUMP (11523-7391-1)",
"NDC11Code": "11523-7391-01",
"ProductNDC": "11523-7391",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Clearly Sheer",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Coppertone Clearly Sheer",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bayer HealthCare LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "31.02; 103.4; 47.05; 93.06; 51.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "25021-147-20",
"PackageDescription": "10 VIAL in 1 CARTON (25021-147-20) / 15 mL in 1 VIAL",
"NDC11Code": "25021-0147-20",
"ProductNDC": "25021-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218140",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1) , 2 Infective Endocarditis (1.2) , 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4) , 5 Lower Respiratory Tract Infections (1.5) .",
"Description": "Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg, 1.28 grams, or 1.54 grams of vancomycin hydrochloride, USP equivalent to 750 mg, 1.25 grams, or 1.5 grams of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "48433-147-03",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (48433-147-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-147-01) ",
"NDC11Code": "48433-0147-03",
"ProductNDC": "48433-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090547",
"LabelerName": "Safecor Health LLC",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2 R,3 S)-2-(2, 4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1 H-1, 2, 4-triazol-1-yl)butan-2-ol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.31. Voriconazole, USP drug substance is a white to almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (corn), titanium dioxide and triacetin."
},
{
"NDCCode": "50228-147-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-147-10) ",
"NDC11Code": "50228-0147-10",
"ProductNDC": "50228-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204687",
"LabelerName": "ScieGen Pharmaceuticals, INC.",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260727",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is off white to white powder. It is soluble in methanol, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder which is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.74, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "50228-147-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50228-147-30) ",
"NDC11Code": "50228-0147-30",
"ProductNDC": "50228-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204687",
"LabelerName": "ScieGen Pharmaceuticals, INC.",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260727",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is off white to white powder. It is soluble in methanol, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder which is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.74, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "55466-147-22",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (55466-147-22) ",
"NDC11Code": "55466-0147-22",
"ProductNDC": "55466-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217451",
"LabelerName": "Neolpharma, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end‐stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate capsules, USP, an influenza neuraminidase inhibitor (NAI), is available as. : 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate."
},
{
"NDCCode": "58443-0238-4",
"PackageDescription": "147 mL in 1 TUBE (58443-0238-4) ",
"NDC11Code": "58443-0238-04",
"ProductNDC": "58443-0238",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "Botanical Mineral Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160715",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Enterprises Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "31.02; 31.02",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160715",
"SamplePackage": "N"
},
{
"NDCCode": "58443-0506-4",
"PackageDescription": "147 mL in 1 TUBE (58443-0506-4) ",
"NDC11Code": "58443-0506-04",
"ProductNDC": "58443-0506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "Botanical Mineral Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200323",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Enterprises Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "31.14; 31.14",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200323",
"SamplePackage": "N",
"IndicationAndUsage": "\"helps prevent sunburn\" if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "59310-610-31",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (59310-610-31) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "59310-0610-31",
"ProductNDC": "59310-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinqair",
"NonProprietaryName": "Reslizumab",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160418",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761033",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "RESLIZUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N",
"IndicationAndUsage": "CINQAIR® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)]. Limitation of Use: 1 CINQAIR is not indicated for treatment of other eosinophilic conditions., 2 CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)].",
"Description": "CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa. CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5."
},
{
"NDCCode": "68225-124-00",
"PackageDescription": "147 VIAL, SINGLE-USE in 1 BOX (68225-124-00) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "68225-0124-00",
"ProductNDC": "68225-124",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Reteplase",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"StartMarketingDate": "19961030",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Italia S.p.A.",
"SubstanceName": "RETEPLASE",
"StrengthNumber": "1.81",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "30-OCT-96",
"EndMarketingDatePackage": "31-DEC-24"
},
{
"NDCCode": "69840-003-03",
"PackageDescription": "147 mL in 1 BOTTLE, DISPENSING (69840-003-03) ",
"NDC11Code": "69840-0003-03",
"ProductNDC": "69840-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yes To Tomatoes Detoxifying Charcoal Cleanser",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150609",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yes To Incorporated",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150609",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "71800-156-31",
"PackageDescription": "100 g in 1 CAN (71800-156-31) ",
"NDC11Code": "71800-0156-31",
"ProductNDC": "71800-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012104",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".147",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N"
},
{
"NDCCode": "83324-131-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (83324-131-90) ",
"NDC11Code": "83324-0131-90",
"ProductNDC": "83324-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fiber Caplets 147",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240827",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Chain Drug Marketing Association Inc.",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240827",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "83324-147-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (83324-147-10) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "83324-0147-10",
"ProductNDC": "83324-147",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075209",
"LabelerName": "QUALITY CHOICE (Chain Drug Marketing Association)",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes , 4 itching of the nose or throat."
},
{
"NDCCode": "83444-301-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (83444-301-10) / 5 mL in 1 VIAL, GLASS",
"NDC11Code": "83444-0301-10",
"ProductNDC": "83444-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Unloxcyt",
"NonProprietaryName": "Cosibelimab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761297",
"LabelerName": "Checkpoint Therapeutics, Inc.",
"SubstanceName": "COSIBELIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.",
"Description": "Cosibelimab-ipdl is a human programmed death ligand-1 (PD-L1) blocking antibody. Cosibelimab-ipdl is a human IgG1 lambda monoclonal antibody. Cosibelimab-ipdl is produced in Chinese hamster ovary (CHO) cells and has a calculated molecular weight of approximately 147 kDa. UNLOXCYT (cosibelimab-ipdl) injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to yellow or slightly brown solution. It is supplied in single-dose vials. Each vial contains 300 mg of UNLOXCYT in 5 mL of solution with a pH of 5.3. Each mL of solution contains 60 mg of cosibelimab-ipdl, acetic acid (0.24 mg), mannitol (37.35 mg), polysorbate 80 (1.1 mg), sodium acetate (1.31 mg), sodium chloride (4.09 mg), and Water for Injection, USP."
},
{
"NDCCode": "83495-101-01",
"PackageDescription": "147 mL in 1 TUBE (83495-101-01) ",
"NDC11Code": "83495-0101-01",
"ProductNDC": "83495-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glowell Spf 30 Tinted Mineral Sunscreen",
"ProprietaryNameSuffix": "Light",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "GLOWELL, LLC.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".005; .142",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83495-102-01",
"PackageDescription": "147 mL in 1 TUBE (83495-102-01) ",
"NDC11Code": "83495-0102-01",
"ProductNDC": "83495-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glowell Spf 30 Tinted Mineral Sunscreen",
"ProprietaryNameSuffix": "Medium",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "GLOWELL, LLC.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".005; .142",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83495-103-01",
"PackageDescription": "147 mL in 1 TUBE (83495-103-01) ",
"NDC11Code": "83495-0103-01",
"ProductNDC": "83495-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glowell Spf 30 Tinted Mineral Sunscreen",
"ProprietaryNameSuffix": "Tan",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "GLOWELL, LLC.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".005; .142",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83495-104-01",
"PackageDescription": "147 mL in 1 TUBE (83495-104-01) ",
"NDC11Code": "83495-0104-01",
"ProductNDC": "83495-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glowell Spf 30 Tinted Mineral Sunscreen",
"ProprietaryNameSuffix": "Deep",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "GLOWELL, LLC.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".005; .142",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "42806-005-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-005-01) ",
"NDC11Code": "42806-0005-01",
"ProductNDC": "42806-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202662",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "42806-006-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-006-01) ",
"NDC11Code": "42806-0006-01",
"ProductNDC": "42806-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202662",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "42806-007-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-007-01) ",
"NDC11Code": "42806-0007-01",
"ProductNDC": "42806-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202662",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "42806-008-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42806-008-01) ",
"NDC11Code": "42806-0008-01",
"ProductNDC": "42806-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202662",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42806-147-31</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, PLASTIC (42806-147-31) </PackageDescription>
<NDC11Code>42806-0147-31</NDC11Code>
<ProductNDC>42806-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207531</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
</NDC>
<NDC>
<NDCCode>58411-147-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-147-60) > 31.25 g in 1 TUBE</PackageDescription>
<NDC11Code>58411-0147-60</NDC11Code>
<ProductNDC>58411-147</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Foundation L</ProprietaryName>
<ProprietaryNameSuffix>O10</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>656</StrengthNumber>
<StrengthUnit>mg/31.25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67777-147-30</NDCCode>
<PackageDescription>24 TUBE in 1 CASE (67777-147-30) / 106 g in 1 TUBE (67777-147-31) </PackageDescription>
<NDC11Code>67777-0147-30</NDC11Code>
<ProductNDC>67777-147</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>D-cerin</ProprietaryName>
<NonProprietaryName>Moisturizer</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>33</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Temporarily protects and helps relieve dry, chapped, or cracked skin. Helps protect skin from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42806-049-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42806-049-01) </PackageDescription>
<NDC11Code>42806-0049-01</NDC11Code>
<ProductNDC>42806-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074673</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131202</StartMarketingDatePackage>
<EndMarketingDatePackage>20180731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42806-049-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42806-049-05) </PackageDescription>
<NDC11Code>42806-0049-05</NDC11Code>
<ProductNDC>42806-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074673</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131202</StartMarketingDatePackage>
<EndMarketingDatePackage>20180731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-4196-05</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4196-05</NDC11Code>
<ProductNDC>0409-4196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Potassium Acetate, Phosphoric Acid, And Magnesium Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017789</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; POTASSIUM ACETATE; PHOSPHORIC ACID; MAGNESIUM ACETATE</SubstanceName>
<StrengthNumber>252; 329; 252; 140; 154; 182; 56; 280; 448; 343; 105; 300; 147; 31; 448; 234; 128; 40; 21</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11523-7368-1</NDCCode>
<PackageDescription>147 mL in 1 BOTTLE, PLASTIC (11523-7368-1)</PackageDescription>
<NDC11Code>11523-7368-01</NDC11Code>
<ProductNDC>11523-7368</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Clearly Sheer For Beach And Pool</ProprietaryName>
<ProprietaryNameSuffix>Spf 50 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>MSD Consumer Care, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>31.02; 103.4; 47.05; 93.06; 51.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>11523-7391-1</NDCCode>
<PackageDescription>147 mL in 1 BOTTLE, PUMP (11523-7391-1)</PackageDescription>
<NDC11Code>11523-7391-01</NDC11Code>
<ProductNDC>11523-7391</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Clearly Sheer</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Coppertone Clearly Sheer</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>31.02; 103.4; 47.05; 93.06; 51.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>25021-147-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-147-20) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0147-20</NDC11Code>
<ProductNDC>25021-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218140</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1) , 2 Infective Endocarditis (1.2) , 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4) , 5 Lower Respiratory Tract Infections (1.5) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin Hydrochloride for Injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg, 1.28 grams, or 1.54 grams of vancomycin hydrochloride, USP equivalent to 750 mg, 1.25 grams, or 1.5 grams of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
</NDC>
<NDC>
<NDCCode>48433-147-03</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (48433-147-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-147-01) </PackageDescription>
<NDC11Code>48433-0147-03</NDC11Code>
<ProductNDC>48433-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090547</ApplicationNumber>
<LabelerName>Safecor Health LLC</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis ( 1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candidainfections ( 1.2) , 3 Esophageal candidiasis ( 1.3) , 4 Serious fungal infections caused by Scedosporium apiospermumand Fusariumspecies including Fusarium solani, in patients intolerant of, or refractory to, other therapy ( 1.4) .</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2 R,3 S)-2-(2, 4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1 H-1, 2, 4-triazol-1-yl)butan-2-ol with an empirical formula of C 16H 14F 3N 5O and a molecular weight of 349.31. Voriconazole, USP drug substance is a white to almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (corn), titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>50228-147-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (50228-147-10) </PackageDescription>
<NDC11Code>50228-0147-10</NDC11Code>
<ProductNDC>50228-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204687</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, INC.</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is off white to white powder. It is soluble in methanol, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder which is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.74, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-147-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50228-147-30) </PackageDescription>
<NDC11Code>50228-0147-30</NDC11Code>
<ProductNDC>50228-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204687</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, INC.</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is off white to white powder. It is soluble in methanol, freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder which is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.74, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55466-147-22</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (55466-147-22) </PackageDescription>
<NDC11Code>55466-0147-22</NDC11Code>
<ProductNDC>55466-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217451</ApplicationNumber>
<LabelerName>Neolpharma, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end‐stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate capsules, USP, an influenza neuraminidase inhibitor (NAI), is available as. : 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate.</Description>
</NDC>
<NDC>
<NDCCode>58443-0238-4</NDCCode>
<PackageDescription>147 mL in 1 TUBE (58443-0238-4) </PackageDescription>
<NDC11Code>58443-0238-04</NDC11Code>
<ProductNDC>58443-0238</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>Botanical Mineral Sunscreen Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Enterprises Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>31.02; 31.02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58443-0506-4</NDCCode>
<PackageDescription>147 mL in 1 TUBE (58443-0506-4) </PackageDescription>
<NDC11Code>58443-0506-04</NDC11Code>
<ProductNDC>58443-0506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>Botanical Mineral Sunscreen Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200323</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Enterprises Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>31.14; 31.14</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>"helps prevent sunburn" if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59310-610-31</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (59310-610-31) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>59310-0610-31</NDC11Code>
<ProductNDC>59310-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinqair</ProprietaryName>
<NonProprietaryName>Reslizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160418</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761033</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>RESLIZUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CINQAIR® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies (14)]. Limitation of Use: 1 CINQAIR is not indicated for treatment of other eosinophilic conditions., 2 CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa. CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>68225-124-00</NDCCode>
<PackageDescription>147 VIAL, SINGLE-USE in 1 BOX (68225-124-00) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>68225-0124-00</NDC11Code>
<ProductNDC>68225-124</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Reteplase</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<StartMarketingDate>19961030</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Italia S.p.A.</LabelerName>
<SubstanceName>RETEPLASE</SubstanceName>
<StrengthNumber>1.81</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>30-OCT-96</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69840-003-03</NDCCode>
<PackageDescription>147 mL in 1 BOTTLE, DISPENSING (69840-003-03) </PackageDescription>
<NDC11Code>69840-0003-03</NDC11Code>
<ProductNDC>69840-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yes To Tomatoes Detoxifying Charcoal Cleanser</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yes To Incorporated</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71800-156-31</NDCCode>
<PackageDescription>100 g in 1 CAN (71800-156-31) </PackageDescription>
<NDC11Code>71800-0156-31</NDC11Code>
<ProductNDC>71800-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012104</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.147</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83324-131-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (83324-131-90) </PackageDescription>
<NDC11Code>83324-0131-90</NDC11Code>
<ProductNDC>83324-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fiber Caplets 147</ProprietaryName>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-147-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (83324-147-10) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>83324-0147-10</NDC11Code>
<ProductNDC>83324-147</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075209</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain Drug Marketing Association)</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83444-301-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (83444-301-10) / 5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>83444-0301-10</NDC11Code>
<ProductNDC>83444-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Unloxcyt</ProprietaryName>
<NonProprietaryName>Cosibelimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250630</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761297</ApplicationNumber>
<LabelerName>Checkpoint Therapeutics, Inc.</LabelerName>
<SubstanceName>COSIBELIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.</IndicationAndUsage>
<Description>Cosibelimab-ipdl is a human programmed death ligand-1 (PD-L1) blocking antibody. Cosibelimab-ipdl is a human IgG1 lambda monoclonal antibody. Cosibelimab-ipdl is produced in Chinese hamster ovary (CHO) cells and has a calculated molecular weight of approximately 147 kDa. UNLOXCYT (cosibelimab-ipdl) injection for intravenous use is a sterile, preservative-free, clear to opalescent, colorless to yellow or slightly brown solution. It is supplied in single-dose vials. Each vial contains 300 mg of UNLOXCYT in 5 mL of solution with a pH of 5.3. Each mL of solution contains 60 mg of cosibelimab-ipdl, acetic acid (0.24 mg), mannitol (37.35 mg), polysorbate 80 (1.1 mg), sodium acetate (1.31 mg), sodium chloride (4.09 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>83495-101-01</NDCCode>
<PackageDescription>147 mL in 1 TUBE (83495-101-01) </PackageDescription>
<NDC11Code>83495-0101-01</NDC11Code>
<ProductNDC>83495-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glowell Spf 30 Tinted Mineral Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Light</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>GLOWELL, LLC.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.005; .142</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83495-102-01</NDCCode>
<PackageDescription>147 mL in 1 TUBE (83495-102-01) </PackageDescription>
<NDC11Code>83495-0102-01</NDC11Code>
<ProductNDC>83495-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glowell Spf 30 Tinted Mineral Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Medium</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>GLOWELL, LLC.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.005; .142</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83495-103-01</NDCCode>
<PackageDescription>147 mL in 1 TUBE (83495-103-01) </PackageDescription>
<NDC11Code>83495-0103-01</NDC11Code>
<ProductNDC>83495-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glowell Spf 30 Tinted Mineral Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Tan</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>GLOWELL, LLC.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.005; .142</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83495-104-01</NDCCode>
<PackageDescription>147 mL in 1 TUBE (83495-104-01) </PackageDescription>
<NDC11Code>83495-0104-01</NDC11Code>
<ProductNDC>83495-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glowell Spf 30 Tinted Mineral Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Deep</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>GLOWELL, LLC.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.005; .142</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42806-005-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42806-005-01) </PackageDescription>
<NDC11Code>42806-0005-01</NDC11Code>
<ProductNDC>42806-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202662</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42806-006-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42806-006-01) </PackageDescription>
<NDC11Code>42806-0006-01</NDC11Code>
<ProductNDC>42806-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202662</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42806-007-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42806-007-01) </PackageDescription>
<NDC11Code>42806-0007-01</NDC11Code>
<ProductNDC>42806-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202662</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42806-008-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42806-008-01) </PackageDescription>
<NDC11Code>42806-0008-01</NDC11Code>
<ProductNDC>42806-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202662</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
</NDCList>