{
"NDC": [
{
"NDCCode": "68428-942-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-942-12)",
"NDC11Code": "68428-0942-12",
"ProductNDC": "68428-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foeniculum Vulgare",
"NonProprietaryName": "Fennel Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FENNEL SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "14783-942-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-942-02) > 12 mL in 1 TUBE (14783-942-01)",
"NDC11Code": "14783-0942-02",
"ProductNDC": "14783-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm",
"ProprietaryNameSuffix": "Caramel Melon - Brown",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151222",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".075; .03",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "63824-942-31",
"PackageDescription": "12 PACKET in 1 CARTON (63824-942-31) > 1 GRANULE in 1 PACKET",
"NDC11Code": "63824-0942-31",
"ProductNDC": "63824-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Childrens",
"ProprietaryNameSuffix": "Cough Mini-melts Orange Creme",
"NonProprietaryName": "Dextromethorphan Hydrobromide And Guaifenesin",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190331",
"EndMarketingDate": "20240225",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "RB Health (US) LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "5; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190331",
"EndMarketingDatePackage": "20240225",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves cough as may occur with a cold."
},
{
"NDCCode": "68428-942-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-942-03) ",
"NDC11Code": "68428-0942-03",
"ProductNDC": "68428-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foeniculum Vulgare",
"NonProprietaryName": "Fennel Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FENNEL SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131212",
"SamplePackage": "N"
},
{
"NDCCode": "68428-942-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-942-05)",
"NDC11Code": "68428-0942-05",
"ProductNDC": "68428-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foeniculum Vulgare",
"NonProprietaryName": "Fennel Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FENNEL SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "68428-942-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-942-06)",
"NDC11Code": "68428-0942-06",
"ProductNDC": "68428-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foeniculum Vulgare",
"NonProprietaryName": "Fennel Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FENNEL SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "68428-942-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-942-11)",
"NDC11Code": "68428-0942-11",
"ProductNDC": "68428-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foeniculum Vulgare",
"NonProprietaryName": "Fennel Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FENNEL SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "11344-942-81",
"PackageDescription": "332 mL in 1 BOTTLE, PUMP (11344-942-81) ",
"NDC11Code": "11344-0942-81",
"ProductNDC": "11344-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "16590-942-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-30)",
"NDC11Code": "16590-0942-30",
"ProductNDC": "16590-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exalgo",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110314",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021217",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.",
"Description": "EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin."
},
{
"NDCCode": "16590-942-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-60)",
"NDC11Code": "16590-0942-60",
"ProductNDC": "16590-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exalgo",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110314",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021217",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.",
"Description": "EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin."
},
{
"NDCCode": "16590-942-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-90)",
"NDC11Code": "16590-0942-90",
"ProductNDC": "16590-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exalgo",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110314",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021217",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.",
"Description": "EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin."
},
{
"NDCCode": "24470-942-02",
"PackageDescription": "57 g in 1 BOTTLE, PLASTIC (24470-942-02) ",
"NDC11Code": "24470-0942-02",
"ProductNDC": "24470-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cintex Services, LLC",
"SubstanceName": "SULFUR; SULFACETAMIDE SODIUM",
"StrengthNumber": "48; 98",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250710",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "33261-942-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-942-30)",
"NDC11Code": "33261-0942-30",
"ProductNDC": "33261-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol And Chlorthalidone",
"NonProprietaryName": "Atenolol And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073665",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL; CHLORTHALIDONE",
"StrengthNumber": "50; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.",
"Description": "Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
},
{
"NDCCode": "33261-942-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (33261-942-60)",
"NDC11Code": "33261-0942-60",
"ProductNDC": "33261-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol And Chlorthalidone",
"NonProprietaryName": "Atenolol And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073665",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL; CHLORTHALIDONE",
"StrengthNumber": "50; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.",
"Description": "Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
},
{
"NDCCode": "33261-942-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (33261-942-90)",
"NDC11Code": "33261-0942-90",
"ProductNDC": "33261-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol And Chlorthalidone",
"NonProprietaryName": "Atenolol And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073665",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ATENOLOL; CHLORTHALIDONE",
"StrengthNumber": "50; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.",
"Description": "Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate."
},
{
"NDCCode": "49349-942-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-942-02)",
"NDC11Code": "49349-0942-02",
"ProductNDC": "49349-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50458-942-01",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-942-01) ",
"NDC11Code": "50458-0942-01",
"ProductNDC": "50458-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokamet Xr",
"NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205879",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "150; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
"Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
},
{
"NDCCode": "51285-942-88",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51285-942-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0942-88",
"ProductNDC": "51285-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plan B One-step",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090728",
"EndMarketingDate": "20160930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "51655-942-26",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-942-26) ",
"NDC11Code": "51655-0942-26",
"ProductNDC": "51655-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077870",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200521",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide USP and metformin hydrochloride USP. Glyburide USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro- o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with molecular formula of C 23H 28ClN 3O 5S and a molecular weight of 494.01. The structural formula is represented below. Metformin hydrochloride USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white to off-white crystalline compound with molecular formula of C 4H 12ClN 5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown:. Glyburide and metformin hydrochloride tablets, USP are available in film-coated containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "55312-942-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55312-942-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55312-0942-01",
"ProductNDC": "55312-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Nighttime",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140926",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Western Family Foods Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 25; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "55700-942-18",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55700-942-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "55700-0942-18",
"ProductNDC": "55700-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20210910",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203062",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210910",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use.",
"Description": "Rizatriptan benzoate orally disintegrating tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.35. Rizatriptan benzoate is a white to almost white crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.Rizatriptan benzoate orally disintegrating tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), and sodium stearyl fumarate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59450-942-14",
"PackageDescription": "156 g in 1 BOTTLE, SPRAY (59450-942-14) ",
"NDC11Code": "59450-0942-14",
"ProductNDC": "59450-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen For Kids Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Kroger Co.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "30; 120; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231108",
"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": "59450-942-15",
"PackageDescription": "258 g in 1 BOTTLE, SPRAY (59450-942-15) ",
"NDC11Code": "59450-0942-15",
"ProductNDC": "59450-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen For Kids Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Kroger",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "30; 120; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231108",
"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": "59651-942-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59651-942-01) ",
"NDC11Code": "59651-0942-01",
"ProductNDC": "59651-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin (macrocrystals)",
"NonProprietaryName": "Nitrofurantoin (macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077025",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241002",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (macrocrystals) and other antibacterial drugs, nitrofurantoin (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION: Nitrofurantoin (macrocrystals) is a synthetic chemical of controlled crystal size. It is lemon-yellow crystals. Nitrofurantoin (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, or 100 mg of nitrofurantoin USP (macrocrystals). 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains black iron oxide, corn starch, gelatin, lactose monohydrate, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. In addition, 25 mg capsule contains red iron oxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "60274-942-01",
"PackageDescription": "103000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-942-01) ",
"NDC11Code": "60274-0942-01",
"ProductNDC": "60274-942",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Societal CDMO Gainesville, LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2022-12-20",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "04-APR-22"
},
{
"NDCCode": "62713-942-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62713-942-01)",
"NDC11Code": "62713-0942-01",
"ProductNDC": "62713-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena",
"ProprietaryNameSuffix": "Pet Dander",
"NonProprietaryName": "Homeopathic Sublingual Immunotherapy",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; MAMMAL LIVER; CORTICOTROPIN; HISTAMINE; FELIS CATUS DANDER; CANIS LUPUS FAMILIARIS DANDER; EQUUS CABALLUS DANDER; BOS TAURUS DANDER; MUS MUSCULUS SKIN; MESOCRICETUS AURATUS SKIN; CAVIA PORCELLUS DANDER; ORYCTOLAGUS CUNICULUS SKIN; SUS SCROFA DANDER; CHICKEN; DUCK; GOOSE; BAPTISIA TINCTORIA; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED",
"StrengthNumber": "4; 3; 12; 30; 12; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 3; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Use: This product is a Homeopathic Dilution formulated to help improve immune function in Infants, Children and Adults."
},
{
"NDCCode": "62756-942-11",
"PackageDescription": "25 kg in 1 DRUM (62756-942-11) ",
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"ProductNDC": "62756-942",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bicalutamide",
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"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "BICALUTAMIDE",
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"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-FEB-18"
},
{
"NDCCode": "63187-942-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (63187-942-14) ",
"NDC11Code": "63187-0942-14",
"ProductNDC": "63187-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "63187-942-20",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Proficient Rx LP",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
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"NDC11Code": "63187-0942-30",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA062500",
"LabelerName": "Proficient Rx LP",
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"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
}
]
}
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<NDC>
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<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-942-12)</PackageDescription>
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<NDC>
<NDCCode>14783-942-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-942-02) > 12 mL in 1 TUBE (14783-942-01)</PackageDescription>
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<ProprietaryName>Lbel Divine Lip Gloss Lip Gloss Spf 15 Fm Brillo Labial Fps 15 Fm</ProprietaryName>
<ProprietaryNameSuffix>Caramel Melon - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
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<StrengthUnit>g/mL; g/mL</StrengthUnit>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<PackageDescription>12 PACKET in 1 CARTON (63824-942-31) > 1 GRANULE in 1 PACKET</PackageDescription>
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<ProductNDC>63824-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex Childrens</ProprietaryName>
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<ApplicationNumber>part341</ApplicationNumber>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves cough as may occur with a cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-942-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-942-03) </PackageDescription>
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<ProductNDC>68428-942</ProductNDC>
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<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FENNEL SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-942-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-942-05)</PackageDescription>
<NDC11Code>68428-0942-05</NDC11Code>
<ProductNDC>68428-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foeniculum Vulgare</ProprietaryName>
<NonProprietaryName>Fennel Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
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<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FENNEL SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68428-942-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-942-06)</PackageDescription>
<NDC11Code>68428-0942-06</NDC11Code>
<ProductNDC>68428-942</ProductNDC>
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<SubstanceName>FENNEL SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68428-942-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-942-11)</PackageDescription>
<NDC11Code>68428-0942-11</NDC11Code>
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<DosageFormName>PELLET</DosageFormName>
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<StartMarketingDate>20131212</StartMarketingDate>
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<SubstanceName>FENNEL SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11344-942-81</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE, PUMP (11344-942-81) </PackageDescription>
<NDC11Code>11344-0942-81</NDC11Code>
<ProductNDC>11344-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>16590-942-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-30)</PackageDescription>
<NDC11Code>16590-0942-30</NDC11Code>
<ProductNDC>16590-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exalgo</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021217</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.</IndicationAndUsage>
<Description>EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>16590-942-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-60)</PackageDescription>
<NDC11Code>16590-0942-60</NDC11Code>
<ProductNDC>16590-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exalgo</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021217</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.</IndicationAndUsage>
<Description>EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>16590-942-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-90)</PackageDescription>
<NDC11Code>16590-0942-90</NDC11Code>
<ProductNDC>16590-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exalgo</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021217</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. EXALGO is NOT intended for use as an as-needed analgesic. EXALGO is not indicated for the management of acute or postoperative pain.</IndicationAndUsage>
<Description>EXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3HCl. The compound has the following structural formula. EXALGO also contains the following inactive ingredients: butylated hydroxytoluene, cellulose acetate, iron oxide black, ferric oxide red (8 mg only), ferric oxide yellow (12 mg and 16 mg only), hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>24470-942-02</NDCCode>
<PackageDescription>57 g in 1 BOTTLE, PLASTIC (24470-942-02) </PackageDescription>
<NDC11Code>24470-0942-02</NDC11Code>
<ProductNDC>24470-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cintex Services, LLC</LabelerName>
<SubstanceName>SULFUR; SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>48; 98</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>33261-942-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-942-30)</PackageDescription>
<NDC11Code>33261-0942-30</NDC11Code>
<ProductNDC>33261-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol And Chlorthalidone</ProprietaryName>
<NonProprietaryName>Atenolol And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073665</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.</IndicationAndUsage>
<Description>Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>33261-942-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (33261-942-60)</PackageDescription>
<NDC11Code>33261-0942-60</NDC11Code>
<ProductNDC>33261-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol And Chlorthalidone</ProprietaryName>
<NonProprietaryName>Atenolol And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073665</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.</IndicationAndUsage>
<Description>Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>33261-942-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (33261-942-90)</PackageDescription>
<NDC11Code>33261-0942-90</NDC11Code>
<ProductNDC>33261-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol And Chlorthalidone</ProprietaryName>
<NonProprietaryName>Atenolol And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073665</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATENOLOL; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone. 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 also have 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 (for example, 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 (eg, n angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.</IndicationAndUsage>
<Description>Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol), and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-. It has the following structural formula. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide. Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula. Each atenolol and chlorthalidone tablet 50 mg-25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet 100 mg-25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and Chlorthalidone Tablets USP, 50 mg-25 mg and 100 mg-25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>49349-942-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-942-02)</PackageDescription>
<NDC11Code>49349-0942-02</NDC11Code>
<ProductNDC>49349-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50458-942-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-942-01) </PackageDescription>
<NDC11Code>50458-0942-01</NDC11Code>
<ProductNDC>50458-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokamet Xr</ProprietaryName>
<NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205879</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.</IndicationAndUsage>
<Description>INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</Description>
</NDC>
<NDC>
<NDCCode>51285-942-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51285-942-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0942-88</NDC11Code>
<ProductNDC>51285-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plan B One-step</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090728</StartMarketingDate>
<EndMarketingDate>20160930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>51655-942-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-942-26) </PackageDescription>
<NDC11Code>51655-0942-26</NDC11Code>
<ProductNDC>51655-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077870</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide USP and metformin hydrochloride USP. Glyburide USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro- o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound with molecular formula of C 23H 28ClN 3O 5S and a molecular weight of 494.01. The structural formula is represented below. Metformin hydrochloride USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white to off-white crystalline compound with molecular formula of C 4H 12ClN 5 (monohydrochloride) and a molecular weight of 165.63. Metformin is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin is 6.68. The structural formula is as shown:. Glyburide and metformin hydrochloride tablets, USP are available in film-coated containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55312-942-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55312-942-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55312-0942-01</NDC11Code>
<ProductNDC>55312-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Nighttime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Western Family Foods Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>55700-942-18</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (55700-942-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55700-0942-18</NDC11Code>
<ProductNDC>55700-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210910</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203062</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use.</IndicationAndUsage>
<Description>Rizatriptan benzoate orally disintegrating tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.35. Rizatriptan benzoate is a white to almost white crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.Rizatriptan benzoate orally disintegrating tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), and sodium stearyl fumarate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>59450-942-14</NDCCode>
<PackageDescription>156 g in 1 BOTTLE, SPRAY (59450-942-14) </PackageDescription>
<NDC11Code>59450-0942-14</NDC11Code>
<ProductNDC>59450-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen For Kids Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 120; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231108</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>59450-942-15</NDCCode>
<PackageDescription>258 g in 1 BOTTLE, SPRAY (59450-942-15) </PackageDescription>
<NDC11Code>59450-0942-15</NDC11Code>
<ProductNDC>59450-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen For Kids Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kroger</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 120; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231108</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>59651-942-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59651-942-01) </PackageDescription>
<NDC11Code>59651-0942-01</NDC11Code>
<ProductNDC>59651-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin (macrocrystals)</ProprietaryName>
<NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077025</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (macrocrystals) and other antibacterial drugs, nitrofurantoin (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION: Nitrofurantoin (macrocrystals) is a synthetic chemical of controlled crystal size. It is lemon-yellow crystals. Nitrofurantoin (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, or 100 mg of nitrofurantoin USP (macrocrystals). 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains black iron oxide, corn starch, gelatin, lactose monohydrate, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. In addition, 25 mg capsule contains red iron oxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>60274-942-01</NDCCode>
<PackageDescription>103000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-942-01) </PackageDescription>
<NDC11Code>60274-0942-01</NDC11Code>
<ProductNDC>60274-942</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Societal CDMO Gainesville, LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-12-20</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-APR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62713-942-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62713-942-01)</PackageDescription>
<NDC11Code>62713-0942-01</NDC11Code>
<ProductNDC>62713-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena</ProprietaryName>
<ProprietaryNameSuffix>Pet Dander</ProprietaryNameSuffix>
<NonProprietaryName>Homeopathic Sublingual Immunotherapy</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; MAMMAL LIVER; CORTICOTROPIN; HISTAMINE; FELIS CATUS DANDER; CANIS LUPUS FAMILIARIS DANDER; EQUUS CABALLUS DANDER; BOS TAURUS DANDER; MUS MUSCULUS SKIN; MESOCRICETUS AURATUS SKIN; CAVIA PORCELLUS DANDER; ORYCTOLAGUS CUNICULUS SKIN; SUS SCROFA DANDER; CHICKEN; DUCK; GOOSE; BAPTISIA TINCTORIA; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED</SubstanceName>
<StrengthNumber>4; 3; 12; 30; 12; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 3; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use: This product is a Homeopathic Dilution formulated to help improve immune function in Infants, Children and Adults.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62756-942-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62756-942-11) </PackageDescription>
<NDC11Code>62756-0942-11</NDC11Code>
<ProductNDC>62756-942</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bicalutamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180202</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>BICALUTAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-FEB-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63187-942-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (63187-942-14) </PackageDescription>
<NDC11Code>63187-0942-14</NDC11Code>
<ProductNDC>63187-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-942-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (63187-942-20) </PackageDescription>
<NDC11Code>63187-0942-20</NDC11Code>
<ProductNDC>63187-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-942-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (63187-942-30) </PackageDescription>
<NDC11Code>63187-0942-30</NDC11Code>
<ProductNDC>63187-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Capsules and Tablets for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2 ∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following Inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
</NDCList>