{
"NDC": [
{
"NDCCode": "55700-619-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-619-60) ",
"NDC11Code": "55700-0619-60",
"ProductNDC": "55700-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180511",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "55700-619-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55700-619-30) ",
"NDC11Code": "55700-0619-30",
"ProductNDC": "55700-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180511",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "55700-619-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55700-619-90) ",
"NDC11Code": "55700-0619-90",
"ProductNDC": "55700-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180511",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "16590-619-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-619-60)",
"NDC11Code": "16590-0619-60",
"ProductNDC": "16590-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Percocet",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "21695-619-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (21695-619-60)",
"NDC11Code": "21695-0619-60",
"ProductNDC": "21695-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040778",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "35356-619-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-619-60) ",
"NDC11Code": "35356-0619-60",
"ProductNDC": "35356-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078525",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180713",
"SamplePackage": "N"
},
{
"NDCCode": "42549-619-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42549-619-60)",
"NDC11Code": "42549-0619-60",
"ProductNDC": "42549-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "47335-619-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-60) ",
"NDC11Code": "47335-0619-60",
"ProductNDC": "47335-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drizalma Sprinkle",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212516",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test."
},
{
"NDCCode": "49999-619-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-619-60)",
"NDC11Code": "49999-0619-60",
"ProductNDC": "49999-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110714",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-619-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63187-619-60) ",
"NDC11Code": "63187-0619-60",
"ProductNDC": "63187-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203623",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).",
"Description": "Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP 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, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "63187-619-90",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63187-619-90) ",
"NDC11Code": "63187-0619-90",
"ProductNDC": "63187-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203623",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).",
"Description": "Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP 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, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "66336-619-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (66336-619-60)",
"NDC11Code": "66336-0619-60",
"ProductNDC": "66336-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin And Caffeine",
"NonProprietaryName": "Butalbital, Aspirin And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19790605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086162",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Butalbital, aspirin, and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Each Butalbital, Aspirin, and Caffeine tablet for oral administration contains. Butalbital, USP 50 mg. Aspirin, USP 325 mg. Caffeine, USP 40 mg. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows. Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc."
},
{
"NDCCode": "68462-619-60",
"PackageDescription": "60 PACKET in 1 BOX (68462-619-60) > 1 POWDER, FOR SUSPENSION in 1 PACKET",
"NDC11Code": "68462-0619-60",
"ProductNDC": "68462-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam Hydrochloride",
"NonProprietaryName": "Colesevelam Hydrochloride",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202190",
"LabelerName": "Glenmark Pharmaceuticals Inc.,USA",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "1.875",
"StrengthUnit": "g/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180717",
"SamplePackage": "N"
},
{
"NDCCode": "71205-619-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-619-60) ",
"NDC11Code": "71205-0619-60",
"ProductNDC": "71205-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075360",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: Management of postherpetic neuralgia in adults 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": "Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17NO 2 and a molecular weight of 171.24. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 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. It has the following structural formula:. Gabapentin capsules, USP are for oral administration and contain 100 mg, 300 mg and 400 mg of gabapentin. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium and magnesium stearate. The 100 mg, 300 mg and 400 mg capsule imprinting ink contains the following inactive ingredients: black iron oxide E172; butyl alcohol; dehydrated alcohol; isopropyl alcohol; potassium hydroxide; propylene glycol; purified water; shellac E904 and strong ammonia solution. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium oxide and yellow iron oxide."
},
{
"NDCCode": "71610-619-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71610-619-53) ",
"NDC11Code": "71610-0619-53",
"ProductNDC": "71610-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211202",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "47335-619-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-10) ",
"NDC11Code": "47335-0619-10",
"ProductNDC": "47335-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drizalma Sprinkle",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212516",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test."
},
{
"NDCCode": "47335-619-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-30) ",
"NDC11Code": "47335-0619-30",
"ProductNDC": "47335-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drizalma Sprinkle",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212516",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test."
},
{
"NDCCode": "47335-619-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-90) ",
"NDC11Code": "47335-0619-90",
"ProductNDC": "47335-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drizalma Sprinkle",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212516",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test."
},
{
"NDCCode": "49999-619-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-619-30)",
"NDC11Code": "49999-0619-30",
"ProductNDC": "49999-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110714",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "82240-619-00",
"PackageDescription": "5 mL in 1 PACKET (82240-619-00) ",
"NDC11Code": "82240-0619-00",
"ProductNDC": "82240-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermaka Sunscreen Spf 42, Tinted",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250603",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "DERMAKA SKIN PRODUCTS",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "60; 77",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250603",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "55700-001-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (55700-001-60)",
"NDC11Code": "55700-0001-60",
"ProductNDC": "55700-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-002-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (55700-002-60)",
"NDC11Code": "55700-0002-60",
"ProductNDC": "55700-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090027",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-20"
},
{
"NDCCode": "55700-003-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (55700-003-60)",
"NDC11Code": "55700-0003-60",
"ProductNDC": "55700-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076017",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-03-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55700-004-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-004-60)",
"NDC11Code": "55700-0004-60",
"ProductNDC": "55700-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55700-005-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (55700-005-60)",
"NDC11Code": "55700-0005-60",
"ProductNDC": "55700-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130522",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040663",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "55700-006-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (55700-006-60)",
"NDC11Code": "55700-0006-60",
"ProductNDC": "55700-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040907",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55700-010-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (55700-010-60)",
"NDC11Code": "55700-0010-60",
"ProductNDC": "55700-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021342",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55700-011-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (55700-011-60)",
"NDC11Code": "55700-0011-60",
"ProductNDC": "55700-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-12-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55700-012-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (55700-012-60)",
"NDC11Code": "55700-0012-60",
"ProductNDC": "55700-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-12-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55700-013-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-013-60)",
"NDC11Code": "55700-0013-60",
"ProductNDC": "55700-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
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<NDCList>
<NDC>
<NDCCode>55700-619-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55700-619-60) </PackageDescription>
<NDC11Code>55700-0619-60</NDC11Code>
<ProductNDC>55700-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>55700-619-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55700-619-30) </PackageDescription>
<NDC11Code>55700-0619-30</NDC11Code>
<ProductNDC>55700-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>55700-619-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55700-619-90) </PackageDescription>
<NDC11Code>55700-0619-90</NDC11Code>
<ProductNDC>55700-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>16590-619-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-619-60)</PackageDescription>
<NDC11Code>16590-0619-60</NDC11Code>
<ProductNDC>16590-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Percocet</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21695-619-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (21695-619-60)</PackageDescription>
<NDC11Code>21695-0619-60</NDC11Code>
<ProductNDC>21695-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040778</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Oxycodone Hydrochloride, USP……………. 10 mg*. Acetaminophen, USP………………………325 mg. *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35356-619-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (35356-619-60) </PackageDescription>
<NDC11Code>35356-0619-60</NDC11Code>
<ProductNDC>35356-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078525</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42549-619-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42549-619-60)</PackageDescription>
<NDC11Code>42549-0619-60</NDC11Code>
<ProductNDC>42549-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain. 50 mg tablets: iron oxide yellow100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>47335-619-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-60) </PackageDescription>
<NDC11Code>47335-0619-60</NDC11Code>
<ProductNDC>47335-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drizalma Sprinkle</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212516</ApplicationNumber>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</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>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test.</Description>
</NDC>
<NDC>
<NDCCode>49999-619-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-619-60)</PackageDescription>
<NDC11Code>49999-0619-60</NDC11Code>
<ProductNDC>49999-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110714</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-619-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-619-60) </PackageDescription>
<NDC11Code>63187-0619-60</NDC11Code>
<ProductNDC>63187-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203623</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).</IndicationAndUsage>
<Description>Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP 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, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>63187-619-90</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-619-90) </PackageDescription>
<NDC11Code>63187-0619-90</NDC11Code>
<ProductNDC>63187-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203623</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).</IndicationAndUsage>
<Description>Sildenafil tablet, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP 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, USP is a white to off white crystalline powder slightly soluble in methanol and a molecular weight of 666.70. Sildenafil tablets are formulated as white to off white, film coated, round tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>66336-619-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (66336-619-60)</PackageDescription>
<NDC11Code>66336-0619-60</NDC11Code>
<ProductNDC>66336-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19790605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086162</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, aspirin, and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each Butalbital, Aspirin, and Caffeine tablet for oral administration contains. Butalbital, USP 50 mg. Aspirin, USP 325 mg. Caffeine, USP 40 mg. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows. Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc.</Description>
</NDC>
<NDC>
<NDCCode>68462-619-60</NDCCode>
<PackageDescription>60 PACKET in 1 BOX (68462-619-60) > 1 POWDER, FOR SUSPENSION in 1 PACKET</PackageDescription>
<NDC11Code>68462-0619-60</NDC11Code>
<ProductNDC>68462-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
<NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202190</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc.,USA</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.875</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-619-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-619-60) </PackageDescription>
<NDC11Code>71205-0619-60</NDC11Code>
<ProductNDC>71205-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075360</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: Management of postherpetic neuralgia in adults 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>Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17NO 2 and a molecular weight of 171.24. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 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. It has the following structural formula:. Gabapentin capsules, USP are for oral administration and contain 100 mg, 300 mg and 400 mg of gabapentin. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium and magnesium stearate. The 100 mg, 300 mg and 400 mg capsule imprinting ink contains the following inactive ingredients: black iron oxide E172; butyl alcohol; dehydrated alcohol; isopropyl alcohol; potassium hydroxide; propylene glycol; purified water; shellac E904 and strong ammonia solution. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-619-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71610-619-53) </PackageDescription>
<NDC11Code>71610-0619-53</NDC11Code>
<ProductNDC>71610-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208677</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-619-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-10) </PackageDescription>
<NDC11Code>47335-0619-10</NDC11Code>
<ProductNDC>47335-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drizalma Sprinkle</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212516</ApplicationNumber>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</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>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test.</Description>
</NDC>
<NDC>
<NDCCode>47335-619-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-30) </PackageDescription>
<NDC11Code>47335-0619-30</NDC11Code>
<ProductNDC>47335-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drizalma Sprinkle</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212516</ApplicationNumber>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</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>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test.</Description>
</NDC>
<NDC>
<NDCCode>47335-619-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-90) </PackageDescription>
<NDC11Code>47335-0619-90</NDC11Code>
<ProductNDC>47335-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drizalma Sprinkle</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212516</ApplicationNumber>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES, INC.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</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>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DRIZALMA SPRINKLE 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 Neuropathy in adults , 4 Fibromyalgia in adults , 5 Chronic Musculoskeletal Pain in adults .</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C18H19NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test.</Description>
</NDC>
<NDC>
<NDCCode>49999-619-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-619-30)</PackageDescription>
<NDC11Code>49999-0619-30</NDC11Code>
<ProductNDC>49999-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110714</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>82240-619-00</NDCCode>
<PackageDescription>5 mL in 1 PACKET (82240-619-00) </PackageDescription>
<NDC11Code>82240-0619-00</NDC11Code>
<ProductNDC>82240-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermaka Sunscreen Spf 42, Tinted</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250603</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>DERMAKA SKIN PRODUCTS</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>60; 77</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55700-001-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55700-001-60)</PackageDescription>
<NDC11Code>55700-0001-60</NDC11Code>
<ProductNDC>55700-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-002-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55700-002-60)</PackageDescription>
<NDC11Code>55700-0002-60</NDC11Code>
<ProductNDC>55700-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090027</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>55700-003-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (55700-003-60)</PackageDescription>
<NDC11Code>55700-0003-60</NDC11Code>
<ProductNDC>55700-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076017</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-004-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-004-60)</PackageDescription>
<NDC11Code>55700-0004-60</NDC11Code>
<ProductNDC>55700-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-005-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55700-005-60)</PackageDescription>
<NDC11Code>55700-0005-60</NDC11Code>
<ProductNDC>55700-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130522</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040663</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>55700-006-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (55700-006-60)</PackageDescription>
<NDC11Code>55700-0006-60</NDC11Code>
<ProductNDC>55700-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040907</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-010-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (55700-010-60)</PackageDescription>
<NDC11Code>55700-0010-60</NDC11Code>
<ProductNDC>55700-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-011-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (55700-011-60)</PackageDescription>
<NDC11Code>55700-0011-60</NDC11Code>
<ProductNDC>55700-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-012-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (55700-012-60)</PackageDescription>
<NDC11Code>55700-0012-60</NDC11Code>
<ProductNDC>55700-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-013-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55700-013-60)</PackageDescription>
<NDC11Code>55700-0013-60</NDC11Code>
<ProductNDC>55700-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>