{
"NDC": [
{
"NDCCode": "40032-081-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-081-03)",
"NDC11Code": "40032-0081-03",
"ProductNDC": "40032-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". .",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 ."
},
{
"NDCCode": "40032-081-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (40032-081-09)",
"NDC11Code": "40032-0081-09",
"ProductNDC": "40032-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". .",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 ."
},
{
"NDCCode": "15127-081-03",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (15127-081-03) > 10 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "15127-0081-03",
"ProductNDC": "15127-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pseudo-free Pe",
"ProprietaryNameSuffix": "Maximum Strength, Non-drowsy",
"NonProprietaryName": "Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"EndMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050114",
"EndMarketingDatePackage": "20210910",
"SamplePackage": "N"
},
{
"NDCCode": "16714-081-03",
"PackageDescription": "90 TABLET in 1 BOTTLE (16714-081-03)",
"NDC11Code": "16714-0081-03",
"ProductNDC": "16714-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040841",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "27241-081-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-081-03)",
"NDC11Code": "27241-0081-03",
"ProductNDC": "27241-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206711",
"LabelerName": "Ajanta Pharma Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43386-081-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43386-081-03) ",
"NDC11Code": "43386-0081-03",
"ProductNDC": "43386-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150330",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and Valsartan Tablet are the combination tablets of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to off-white hygroscopic powder, soluble in ethanol and methanol and insoluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and Valsartan Tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate (6.9 mg or 13.9 mg), equivalent to 5 mg or 10 mg of amlodipine respectively, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, mannitol and sodium starch glycolate."
},
{
"NDCCode": "43595-081-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43595-081-03)",
"NDC11Code": "43595-0081-03",
"ProductNDC": "43595-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oleptro",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022411",
"LabelerName": "Angelini Pharma Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-03-25"
},
{
"NDCCode": "53145-081-03",
"PackageDescription": "86 g in 1 JAR (53145-081-03) ",
"NDC11Code": "53145-0081-03",
"ProductNDC": "53145-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mascura La Vaca Plus",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "MENPER DISTRIBUTORS, INC.",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "10.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190619",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains."
},
{
"NDCCode": "57344-081-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (57344-081-03) > 250 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "57344-0081-03",
"ProductNDC": "57344-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "AAA Pharmaceutical, Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "58159-081-03",
"PackageDescription": "15 kg in 1 DRUM (58159-081-03)",
"NDC11Code": "58159-0081-03",
"ProductNDC": "58159-081",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20201008",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2020-10-17",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "61786-081-03",
"PackageDescription": "20 TABLET in 1 BOTTLE (61786-081-03)",
"NDC11Code": "61786-0081-03",
"ProductNDC": "61786-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "63545-081-03",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-081-03) ",
"NDC11Code": "63545-0081-03",
"ProductNDC": "63545-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aralia Racemosa",
"NonProprietaryName": "Aralia Racemosa",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARALIA RACEMOSA ROOT",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N"
},
{
"NDCCode": "65162-081-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65162-081-03) ",
"NDC11Code": "65162-0081-03",
"ProductNDC": "65162-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207480",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230719",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one 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 (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, 5 mg contains iron oxide yellow.FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "77490-081-03",
"PackageDescription": "235 mL in 1 BOTTLE, SPRAY (77490-081-03) ",
"NDC11Code": "77490-0081-03",
"ProductNDC": "77490-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "On-the-spot Scented Hand Sanitizer White Tea",
"NonProprietaryName": "Scented Hand Sanitizer Spray White Tea",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "On The Spot Products, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N"
},
{
"NDCCode": "79753-081-03",
"PackageDescription": "2.5 mL in 1 POUCH (79753-081-03) ",
"NDC11Code": "79753-0081-03",
"ProductNDC": "79753-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coola Refreshing Water Plumping Gel Serum Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COOLA LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 6; 5; 7",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 helps prevent sunburn."
},
{
"NDCCode": "82953-081-03",
"PackageDescription": "12 mL in 1 VIAL, PLASTIC (82953-081-03) ",
"NDC11Code": "82953-0081-03",
"ProductNDC": "82953-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf30 Sunscreen",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Avobenzone ,homosalate,octocrylene, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cosmuses Cosmetics (Ningbo) Co., Ltd.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "2.7; 7; 7; 4.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "40032-034-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (40032-034-03) ",
"NDC11Code": "40032-0034-03",
"ProductNDC": "40032-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin Hydrochloride",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207285",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170213",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin hydrochloride is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below. Community Acquired Pneumonia (1.1). Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3). Complicated Intra-Abdominal Infections (1.4). Plague (1.5). Acute Bacterial Sinusitis (1.6). Acute Bacterial Exacerbation of Chronic Bronchitis (1.7). To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.8).",
"Description": "Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8 diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows:."
},
{
"NDCCode": "40032-080-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-080-03)",
"NDC11Code": "40032-0080-03",
"ProductNDC": "40032-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". .",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 ."
},
{
"NDCCode": "40032-082-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-082-03)",
"NDC11Code": "40032-0082-03",
"ProductNDC": "40032-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". .",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 ."
},
{
"NDCCode": "40032-083-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-083-03)",
"NDC11Code": "40032-0083-03",
"ProductNDC": "40032-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202829",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": ". .",
"Description": "Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 ."
},
{
"NDCCode": "40032-088-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (40032-088-03) ",
"NDC11Code": "40032-0088-03",
"ProductNDC": "40032-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "40032-089-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (40032-089-03) ",
"NDC11Code": "40032-0089-03",
"ProductNDC": "40032-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "40032-118-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-118-03) ",
"NDC11Code": "40032-0118-03",
"ProductNDC": "40032-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091528",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
"StrengthNumber": "5; 1.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140923",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]., 3 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP contains hydrocodone an opioid agonist, and homatropine a muscarinic antagonist. Each tablet of Hydrocodone Bitartrate and Homatropine Methylbromide contains 5 mg of Hydrocodone Bitartrate, USP and 1.5 mg of Homatropine Methylbromide, USP for oral administartion. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contains the following inactive ingredients: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy- 17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17 methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.490 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure. C17H24BrNO3 HOMATROPINE METHYLBROMIDE."
},
{
"NDCCode": "40032-351-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-351-03) ",
"NDC11Code": "40032-0351-03",
"ProductNDC": "40032-351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "300; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-352-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-352-03) ",
"NDC11Code": "40032-0352-03",
"ProductNDC": "40032-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "300; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-353-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-353-03) ",
"NDC11Code": "40032-0353-03",
"ProductNDC": "40032-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206142",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "300; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-356-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-356-03) ",
"NDC11Code": "40032-0356-03",
"ProductNDC": "40032-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-357-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-357-03) ",
"NDC11Code": "40032-0357-03",
"ProductNDC": "40032-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-358-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-358-03) ",
"NDC11Code": "40032-0358-03",
"ProductNDC": "40032-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206245",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2."
},
{
"NDCCode": "40032-430-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-430-03) ",
"NDC11Code": "40032-0430-03",
"ProductNDC": "40032-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204021",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base."
}
]
}
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<NDC>
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<PackageDescription>30 TABLET in 1 BOTTLE (40032-081-03)</PackageDescription>
<NDC11Code>40032-0081-03</NDC11Code>
<ProductNDC>40032-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. .</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 .</Description>
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<NDC>
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<PackageDescription>90 TABLET in 1 BOTTLE (40032-081-09)</PackageDescription>
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<ProductNDC>40032-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. .</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 .</Description>
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<NDC>
<NDCCode>15127-081-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (15127-081-03) > 10 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>15127-0081-03</NDC11Code>
<ProductNDC>15127-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pseudo-free Pe</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength, Non-drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050114</StartMarketingDate>
<EndMarketingDate>20210910</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050114</StartMarketingDatePackage>
<EndMarketingDatePackage>20210910</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-081-03</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16714-081-03)</PackageDescription>
<NDC11Code>16714-0081-03</NDC11Code>
<ProductNDC>16714-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040841</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>27241-081-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (27241-081-03)</PackageDescription>
<NDC11Code>27241-0081-03</NDC11Code>
<ProductNDC>27241-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206711</ApplicationNumber>
<LabelerName>Ajanta Pharma Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43386-081-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43386-081-03) </PackageDescription>
<NDC11Code>43386-0081-03</NDC11Code>
<ProductNDC>43386-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and Valsartan Tablet are the combination tablets of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and Valsartan Tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to off-white hygroscopic powder, soluble in ethanol and methanol and insoluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and Valsartan Tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate (6.9 mg or 13.9 mg), equivalent to 5 mg or 10 mg of amlodipine respectively, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, mannitol and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43595-081-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43595-081-03)</PackageDescription>
<NDC11Code>43595-0081-03</NDC11Code>
<ProductNDC>43595-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oleptro</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022411</ApplicationNumber>
<LabelerName>Angelini Pharma Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-03-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>53145-081-03</NDCCode>
<PackageDescription>86 g in 1 JAR (53145-081-03) </PackageDescription>
<NDC11Code>53145-0081-03</NDC11Code>
<ProductNDC>53145-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mascura La Vaca Plus</ProprietaryName>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>MENPER DISTRIBUTORS, INC.</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains.</IndicationAndUsage>
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<NDC>
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<NDC11Code>57344-0081-03</NDC11Code>
<ProductNDC>57344-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>AAA Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDC11Code>58159-0081-03</NDC11Code>
<ProductNDC>58159-081</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20201008</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-10-17</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61786-081-03</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (61786-081-03)</PackageDescription>
<NDC11Code>61786-0081-03</NDC11Code>
<ProductNDC>61786-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
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<NDCCode>63545-081-03</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-081-03) </PackageDescription>
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<ProductNDC>63545-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aralia Racemosa</ProprietaryName>
<NonProprietaryName>Aralia Racemosa</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARALIA RACEMOSA ROOT</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65162-081-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65162-081-03) </PackageDescription>
<NDC11Code>65162-0081-03</NDC11Code>
<ProductNDC>65162-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207480</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one 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 (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, 5 mg contains iron oxide yellow.FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>77490-081-03</NDCCode>
<PackageDescription>235 mL in 1 BOTTLE, SPRAY (77490-081-03) </PackageDescription>
<NDC11Code>77490-0081-03</NDC11Code>
<ProductNDC>77490-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>On-the-spot Scented Hand Sanitizer White Tea</ProprietaryName>
<NonProprietaryName>Scented Hand Sanitizer Spray White Tea</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>On The Spot Products, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79753-081-03</NDCCode>
<PackageDescription>2.5 mL in 1 POUCH (79753-081-03) </PackageDescription>
<NDC11Code>79753-0081-03</NDC11Code>
<ProductNDC>79753-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coola Refreshing Water Plumping Gel Serum Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COOLA LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 6; 5; 7</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82953-081-03</NDCCode>
<PackageDescription>12 mL in 1 VIAL, PLASTIC (82953-081-03) </PackageDescription>
<NDC11Code>82953-0081-03</NDC11Code>
<ProductNDC>82953-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf30 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone ,homosalate,octocrylene, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cosmuses Cosmetics (Ningbo) Co., Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>2.7; 7; 7; 4.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>40032-034-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (40032-034-03) </PackageDescription>
<NDC11Code>40032-0034-03</NDC11Code>
<ProductNDC>40032-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207285</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin hydrochloride is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below. Community Acquired Pneumonia (1.1). Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3). Complicated Intra-Abdominal Infections (1.4). Plague (1.5). Acute Bacterial Sinusitis (1.6). Acute Bacterial Exacerbation of Chronic Bronchitis (1.7). To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.8).</IndicationAndUsage>
<Description>Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8 diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>40032-080-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-080-03)</PackageDescription>
<NDC11Code>40032-0080-03</NDC11Code>
<ProductNDC>40032-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. .</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>40032-082-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-082-03)</PackageDescription>
<NDC11Code>40032-0082-03</NDC11Code>
<ProductNDC>40032-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. .</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>40032-083-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-083-03)</PackageDescription>
<NDC11Code>40032-0083-03</NDC11Code>
<ProductNDC>40032-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202829</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. .</IndicationAndUsage>
<Description>Amlodipine and Valsartan Tablets are a fixed combination of amlodipine and valsartan. Amlodipine and Valsartan Tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>40032-088-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (40032-088-03) </PackageDescription>
<NDC11Code>40032-0088-03</NDC11Code>
<ProductNDC>40032-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>40032-089-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (40032-089-03) </PackageDescription>
<NDC11Code>40032-0089-03</NDC11Code>
<ProductNDC>40032-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>40032-118-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-118-03) </PackageDescription>
<NDC11Code>40032-0118-03</NDC11Code>
<ProductNDC>40032-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091528</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE</SubstanceName>
<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Homatropine Methylbromide Tablets are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]., 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ]., 3 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Hydrocodone Bitartrate and Homatropine Methylbromide Tablets for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP contains hydrocodone an opioid agonist, and homatropine a muscarinic antagonist. Each tablet of Hydrocodone Bitartrate and Homatropine Methylbromide contains 5 mg of Hydrocodone Bitartrate, USP and 1.5 mg of Homatropine Methylbromide, USP for oral administartion. Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contains the following inactive ingredients: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. Hydrocodone Bitartrate. The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy- 17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17 methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.490 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-8, 8-dimethyl-,bromide,endo. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure. C17H24BrNO3 HOMATROPINE METHYLBROMIDE.</Description>
</NDC>
<NDC>
<NDCCode>40032-351-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-351-03) </PackageDescription>
<NDC11Code>40032-0351-03</NDC11Code>
<ProductNDC>40032-351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>300; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-352-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-352-03) </PackageDescription>
<NDC11Code>40032-0352-03</NDC11Code>
<ProductNDC>40032-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>300; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-353-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-353-03) </PackageDescription>
<NDC11Code>40032-0353-03</NDC11Code>
<ProductNDC>40032-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206142</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>300; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 300 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 300 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-356-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-356-03) </PackageDescription>
<NDC11Code>40032-0356-03</NDC11Code>
<ProductNDC>40032-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-357-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-357-03) </PackageDescription>
<NDC11Code>40032-0357-03</NDC11Code>
<ProductNDC>40032-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-358-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-358-03) </PackageDescription>
<NDC11Code>40032-0358-03</NDC11Code>
<ProductNDC>40032-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206245</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 have not been tolerated, or are not expected to be tolerated,, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:. Hydrocodone Bitartrate ...... 5 mg. Acetaminophen................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ................ 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen.............. 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>40032-430-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-430-03) </PackageDescription>
<NDC11Code>40032-0430-03</NDC11Code>
<ProductNDC>40032-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204021</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Limitations of Use (1). Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg ,or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. Apart from the above ingredients, 10 mg tablet contains lake blend LB-1171 (gray powder), 15 mg tablet contains lake blend LB-451 (green), 20 mg tablet contains lake blend LB-1635 (pink powder) and 30 mg tablet contains lake blend LB-105000 (blue powder). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
</NDCList>