{
"NDC": [
{
"NDCCode": "82009-071-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-071-05) ",
"NDC11Code": "82009-0071-05",
"ProductNDC": "82009-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200651",
"LabelerName": "QUALLENT PHARMACEUTICALS HEALTH LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230901",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "11410-071-05",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (11410-071-05) > 89 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "11410-0071-05",
"ProductNDC": "11410-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Deep Cleansing Body Wash",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200201",
"EndMarketingDate": "20231104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Alchemee, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200201",
"EndMarketingDatePackage": "20231104",
"SamplePackage": "N"
},
{
"NDCCode": "13107-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13107-071-05) ",
"NDC11Code": "13107-0071-05",
"ProductNDC": "13107-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202424",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131127",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed salts of single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD)A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. 11.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied21.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied32.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied43.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied53.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied65 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied77.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as suppliedInactive IngredientsIn addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.ColorsThe 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue#1 Aluminum Lake.The 12.5 mg, 15 mg, 20 mg and 30 mg tablets contain the color additive FD&C Yellow#6 Aluminum Lake."
},
{
"NDCCode": "16714-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (16714-071-05) ",
"NDC11Code": "16714-0071-05",
"ProductNDC": "16714-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078504",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110101",
"SamplePackage": "N"
},
{
"NDCCode": "27241-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (27241-071-05) ",
"NDC11Code": "27241-0071-05",
"ProductNDC": "27241-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206528",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150827",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a fine white to off-white powder and is soluble in water.Memantine Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, talc and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc, FD & C yellow #6/sunset yellow FCF aluminum lake (5 mg tablets), and polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc and iron oxide black (10 mg tablets). USP Assay test pending."
},
{
"NDCCode": "51407-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (51407-071-05) ",
"NDC11Code": "51407-0071-05",
"ProductNDC": "51407-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090749",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231206",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b, f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.10 (fumarate salt). The structural formula is: : 1 ."
},
{
"NDCCode": "52343-071-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (52343-071-05) ",
"NDC11Code": "52343-0071-05",
"ProductNDC": "52343-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141106",
"SamplePackage": "N"
},
{
"NDCCode": "54077-071-05",
"PackageDescription": "1 BAG in 1 CARTON (54077-071-05) / 10 kg in 1 BAG",
"NDC11Code": "54077-0071-05",
"ProductNDC": "54077-071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Thiamine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150618",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jiangxi Tianxin Pharmaceutical Co., Ltd.",
"SubstanceName": "THIAMINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-10-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-OCT-17"
},
{
"NDCCode": "57237-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (57237-071-05)",
"NDC11Code": "57237-0071-05",
"ProductNDC": "57237-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202050",
"LabelerName": "Citron Pharma LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "58159-071-05",
"PackageDescription": "5 kg in 1 DRUM (58159-071-05) ",
"NDC11Code": "58159-0071-05",
"ProductNDC": "58159-071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dichlorphenamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "DICHLORPHENAMIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-DEC-24"
},
{
"NDCCode": "60429-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (60429-071-05)",
"NDC11Code": "60429-0071-05",
"ProductNDC": "60429-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110512",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075657",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "67850-071-05",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (67850-071-05) / 2 mL in 1 VIAL, SINGLE-DOSE (67850-071-00) ",
"NDC11Code": "67850-0071-05",
"ProductNDC": "67850-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215829",
"LabelerName": "Methapharm Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210203",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).",
"Description": "Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "68382-071-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-071-05) ",
"NDC11Code": "68382-0071-05",
"ProductNDC": "68382-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077751",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100330",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablet, USP is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).",
"Description": "Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet, USP intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous."
},
{
"NDCCode": "71052-071-05",
"PackageDescription": "100 g in 1 CONTAINER (71052-071-05) ",
"NDC11Code": "71052-0071-05",
"ProductNDC": "71052-071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anamorelin Hci",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240919",
"EndMarketingDate": "20300401",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "ANAMORELIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-04-15",
"StartMarketingDatePackage": "19-SEP-24",
"EndMarketingDatePackage": "01-APR-30"
},
{
"NDCCode": "72241-071-05",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72241-071-05) ",
"NDC11Code": "72241-0071-05",
"ProductNDC": "72241-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218045",
"LabelerName": "Modavar Pharmaceuticals LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder with a slightly soluble in water and methanol, practically insoluble in hexane and a molecular weight of 666.7. Sildenafil tablets USP is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake. It meets USP Dissolution Test 2."
},
{
"NDCCode": "73212-071-05",
"PackageDescription": "5 g in 1 BOTTLE (73212-071-05) ",
"NDC11Code": "73212-0071-05",
"ProductNDC": "73212-071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Snap-8",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230417",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "ACETYL OCTAPEPTIDE-3",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "17-APR-23"
},
{
"NDCCode": "73569-071-05",
"PackageDescription": "50 g in 1 BOTTLE (73569-071-05) ",
"NDC11Code": "73569-0071-05",
"ProductNDC": "73569-071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ll-37",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Peptites Biotech",
"SubstanceName": "ROPOCAMPTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-25"
},
{
"NDCCode": "75594-071-05",
"PackageDescription": "1.89 L in 1 BOTTLE, PUMP (75594-071-05) ",
"NDC11Code": "75594-0071-05",
"ProductNDC": "75594-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Commercial Beverage Concepts, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200723",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75907-071-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) ",
"NDC11Code": "75907-0071-05",
"ProductNDC": "75907-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "84515-071-05",
"PackageDescription": "5 g in 1 BOX (84515-071-05) ",
"NDC11Code": "84515-0071-05",
"ProductNDC": "84515-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Dark Spot Corrector",
"NonProprietaryName": "Trstay Dark Spot Corrector",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240828",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E - Commerce Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240828",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "82009-008-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (82009-008-05) ",
"NDC11Code": "82009-0008-05",
"ProductNDC": "82009-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "Quallent",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211203",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: : 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. , 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. , 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets for oral use contains 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide."
},
{
"NDCCode": "82009-016-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05) ",
"NDC11Code": "82009-0016-05",
"ProductNDC": "82009-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200895",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220526",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β (2 S*,4 S*),-8a]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "82009-021-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) ",
"NDC11Code": "82009-0021-05",
"ProductNDC": "82009-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221115",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076273",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221115",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"Description": "Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. Each tablet contains 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol and microcrystalline cellulose as inactive ingredients. The film coating contains hypromellose 2910-5cP, polyethylene glycol 400 and titanium dioxide."
},
{
"NDCCode": "82009-023-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05) ",
"NDC11Code": "82009-0023-05",
"ProductNDC": "82009-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078490",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells contains: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "82009-024-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (82009-024-05) ",
"NDC11Code": "82009-0024-05",
"ProductNDC": "82009-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204331",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220820",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .",
"Description": "Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate."
},
{
"NDCCode": "82009-029-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05) ",
"NDC11Code": "82009-0029-05",
"ProductNDC": "82009-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Quallent Pharmaceuticals Health, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "82009-039-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05) ",
"NDC11Code": "82009-0039-05",
"ProductNDC": "82009-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203083",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221014",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1) Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) Maintenance of healed duodenal ulcers in adults. ( 1.3) Treatment of active benign gastric ulcer in adults. ( 1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) Maintenance of healing of EE in adults. ( 1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.36. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole delayed-release capsules, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "82009-045-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05) ",
"NDC11Code": "82009-0045-05",
"ProductNDC": "82009-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide."
},
{
"NDCCode": "82009-049-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05) ",
"NDC11Code": "82009-0049-05",
"ProductNDC": "82009-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "82009-050-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-050-05) ",
"NDC11Code": "82009-0050-05",
"ProductNDC": "82009-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>82009-071-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-071-05) </PackageDescription>
<NDC11Code>82009-0071-05</NDC11Code>
<ProductNDC>82009-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200651</ApplicationNumber>
<LabelerName>QUALLENT PHARMACEUTICALS HEALTH LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.</Description>
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<NDC>
<NDCCode>11410-071-05</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (11410-071-05) > 89 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>11410-0071-05</NDC11Code>
<ProductNDC>11410-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Deep Cleansing Body Wash</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<EndMarketingDate>20231104</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Alchemee, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<EndMarketingDatePackage>20231104</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>13107-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13107-071-05) </PackageDescription>
<NDC11Code>13107-0071-05</NDC11Code>
<ProductNDC>13107-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202424</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.125; 3.125; 3.125; 3.125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed salts of single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD)A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. 11.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied21.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied32.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied43.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied53.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied65 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied77.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as suppliedInactive IngredientsIn addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.ColorsThe 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue#1 Aluminum Lake.The 12.5 mg, 15 mg, 20 mg and 30 mg tablets contain the color additive FD&C Yellow#6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16714-071-05) </PackageDescription>
<NDC11Code>16714-0071-05</NDC11Code>
<ProductNDC>16714-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078504</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27241-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (27241-071-05) </PackageDescription>
<NDC11Code>27241-0071-05</NDC11Code>
<ProductNDC>27241-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206528</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a fine white to off-white powder and is soluble in water.Memantine Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, talc and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc, FD & C yellow #6/sunset yellow FCF aluminum lake (5 mg tablets), and polyvinyl alcohol, polyethylene glycol 4000/macrogol, titanium dioxide, talc and iron oxide black (10 mg tablets). USP Assay test pending.</Description>
</NDC>
<NDC>
<NDCCode>51407-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (51407-071-05) </PackageDescription>
<NDC11Code>51407-0071-05</NDC11Code>
<ProductNDC>51407-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090749</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b, f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.10 (fumarate salt). The structural formula is: : 1 .</Description>
</NDC>
<NDC>
<NDCCode>52343-071-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (52343-071-05) </PackageDescription>
<NDC11Code>52343-0071-05</NDC11Code>
<ProductNDC>52343-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54077-071-05</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (54077-071-05) / 10 kg in 1 BAG</PackageDescription>
<NDC11Code>54077-0071-05</NDC11Code>
<ProductNDC>54077-071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150618</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jiangxi Tianxin Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>57237-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (57237-071-05)</PackageDescription>
<NDC11Code>57237-0071-05</NDC11Code>
<ProductNDC>57237-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202050</ApplicationNumber>
<LabelerName>Citron Pharma LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>58159-071-05</NDCCode>
<PackageDescription>5 kg in 1 DRUM (58159-071-05) </PackageDescription>
<NDC11Code>58159-0071-05</NDC11Code>
<ProductNDC>58159-071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dichlorphenamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>DICHLORPHENAMIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60429-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (60429-071-05)</PackageDescription>
<NDC11Code>60429-0071-05</NDC11Code>
<ProductNDC>60429-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110512</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075657</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>67850-071-05</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (67850-071-05) / 2 mL in 1 VIAL, SINGLE-DOSE (67850-071-00) </PackageDescription>
<NDC11Code>67850-0071-05</NDC11Code>
<ProductNDC>67850-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215829</ApplicationNumber>
<LabelerName>Methapharm Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula. Molecular weight: 491.06. Molecular formula: C 27H 38N 2O 4∙ HCl. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>68382-071-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-071-05) </PackageDescription>
<NDC11Code>68382-0071-05</NDC11Code>
<ProductNDC>68382-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077751</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablet, USP is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1), 2 Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1), 3 Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2), 4 Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2), 5 Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2), 6 Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2).</IndicationAndUsage>
<Description>Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is freely soluble in water and in methanol. Soluble in ethanol. Each pravastatin sodium tablet, USP intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyoxyl 35 castor oil and sodium carbonate anhydrous.</Description>
</NDC>
<NDC>
<NDCCode>71052-071-05</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (71052-071-05) </PackageDescription>
<NDC11Code>71052-0071-05</NDC11Code>
<ProductNDC>71052-071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anamorelin Hci</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240919</StartMarketingDate>
<EndMarketingDate>20300401</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>ANAMORELIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-15</LastUpdate>
<StartMarketingDatePackage>19-SEP-24</StartMarketingDatePackage>
<EndMarketingDatePackage>01-APR-30</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72241-071-05</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (72241-071-05) </PackageDescription>
<NDC11Code>72241-0071-05</NDC11Code>
<ProductNDC>72241-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218045</ApplicationNumber>
<LabelerName>Modavar Pharmaceuticals LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder with a slightly soluble in water and methanol, practically insoluble in hexane and a molecular weight of 666.7. Sildenafil tablets USP is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake. It meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>73212-071-05</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (73212-071-05) </PackageDescription>
<NDC11Code>73212-0071-05</NDC11Code>
<ProductNDC>73212-071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Snap-8</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230417</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>ACETYL OCTAPEPTIDE-3</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-APR-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>73569-071-05</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (73569-071-05) </PackageDescription>
<NDC11Code>73569-0071-05</NDC11Code>
<ProductNDC>73569-071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ll-37</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Peptites Biotech</LabelerName>
<SubstanceName>ROPOCAMPTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>75594-071-05</NDCCode>
<PackageDescription>1.89 L in 1 BOTTLE, PUMP (75594-071-05) </PackageDescription>
<NDC11Code>75594-0071-05</NDC11Code>
<ProductNDC>75594-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Commercial Beverage Concepts, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75907-071-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) </PackageDescription>
<NDC11Code>75907-0071-05</NDC11Code>
<ProductNDC>75907-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>84515-071-05</NDCCode>
<PackageDescription>5 g in 1 BOX (84515-071-05) </PackageDescription>
<NDC11Code>84515-0071-05</NDC11Code>
<ProductNDC>84515-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Dark Spot Corrector</ProprietaryName>
<NonProprietaryName>Trstay Dark Spot Corrector</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E - Commerce Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240828</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82009-008-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82009-008-05) </PackageDescription>
<NDC11Code>82009-0008-05</NDC11Code>
<ProductNDC>82009-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>Quallent</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: : 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. , 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. , 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets for oral use contains 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-016-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05) </PackageDescription>
<NDC11Code>82009-0016-05</NDC11Code>
<ProductNDC>82009-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200895</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β (2 S*,4 S*),-8a]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>82009-021-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) </PackageDescription>
<NDC11Code>82009-0021-05</NDC11Code>
<ProductNDC>82009-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076273</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. Each tablet contains 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol and microcrystalline cellulose as inactive ingredients. The film coating contains hypromellose 2910-5cP, polyethylene glycol 400 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-023-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05) </PackageDescription>
<NDC11Code>82009-0023-05</NDC11Code>
<ProductNDC>82009-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078490</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells contains: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>82009-024-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82009-024-05) </PackageDescription>
<NDC11Code>82009-0024-05</NDC11Code>
<ProductNDC>82009-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204331</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
<Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>82009-029-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05) </PackageDescription>
<NDC11Code>82009-0029-05</NDC11Code>
<ProductNDC>82009-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-039-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05) </PackageDescription>
<NDC11Code>82009-0039-05</NDC11Code>
<ProductNDC>82009-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203083</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1) Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) Maintenance of healed duodenal ulcers in adults. ( 1.3) Treatment of active benign gastric ulcer in adults. ( 1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) Maintenance of healing of EE in adults. ( 1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.36. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole delayed-release capsules, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-045-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05) </PackageDescription>
<NDC11Code>82009-0045-05</NDC11Code>
<ProductNDC>82009-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-049-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05) </PackageDescription>
<NDC11Code>82009-0049-05</NDC11Code>
<ProductNDC>82009-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82009-050-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-050-05) </PackageDescription>
<NDC11Code>82009-0050-05</NDC11Code>
<ProductNDC>82009-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
</NDCList>