{
"NDC": [
{
"NDCCode": "70756-085-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-085-11) ",
"NDC11Code": "70756-0085-11",
"ProductNDC": "70756-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215885",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "10202-085-01",
"PackageDescription": "59 mL in 1 BOTTLE (10202-085-01)",
"NDC11Code": "10202-0085-01",
"ProductNDC": "10202-085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7-11 Instant Hand Sanitizer With Aloe And Vitamin E",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111102",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "7-11",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "A hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "13107-085-11",
"PackageDescription": "10 TABLET in 1 BOTTLE (13107-085-11) ",
"NDC11Code": "13107-0085-11",
"ProductNDC": "13107-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203572",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N"
},
{
"NDCCode": "33342-085-11",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-11) ",
"NDC11Code": "33342-0085-11",
"ProductNDC": "33342-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20150227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203044",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150227",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2."
},
{
"NDCCode": "43598-085-25",
"PackageDescription": "25 VIAL in 1 CARTON (43598-085-25) > 1 mL in 1 VIAL (43598-085-11) ",
"NDC11Code": "43598-0085-25",
"ProductNDC": "43598-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204485",
"LabelerName": "DR. REDDYS LABORATORIES INC",
"SubstanceName": "VASOPRESSIN, UNSPECIFIED",
"StrengthNumber": "20",
"StrengthUnit": "[USP'U]/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23. One mg is equivalent to 530 units."
},
{
"NDCCode": "50268-085-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-085-15) > 1 TABLET in 1 BLISTER PACK (50268-085-11) ",
"NDC11Code": "50268-0085-15",
"ProductNDC": "50268-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "AvPAK",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-02-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140123",
"SamplePackage": "N"
},
{
"NDCCode": "68084-085-21",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68084-085-21) > 10 TABLET in 1 BLISTER PACK (68084-085-11)",
"NDC11Code": "68084-0085-21",
"ProductNDC": "68084-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077414",
"LabelerName": "American Health Packaging",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "70377-085-11",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70377-085-11) ",
"NDC11Code": "70377-0085-11",
"ProductNDC": "70377-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217217",
"LabelerName": "Biocon Pharma Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib tablets are a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is soluble in N,N-dimethylformamide and insoluble in acetonitrile. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, administered orally, with the following inactive ingredients: anhydrous lactose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate. The tablet coating consists of polyvinyl alcohol, glycerol esters of fatty acids, talc, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "71209-085-11",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (71209-085-11) ",
"NDC11Code": "71209-0085-11",
"ProductNDC": "71209-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211325",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180630",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white to off-white powder, soluble in water and in alcohol. Insoluble in ether and in chloroform. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg or 300 mg of labetalol hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, opadry white, polysorbate, and sodium starch glycolate (potato). Opadry white contains hypromellose, polyethylene glycol, titanium dioxide, and talc."
},
{
"NDCCode": "73212-085-11",
"PackageDescription": "50 g in 1 BOTTLE (73212-085-11) ",
"NDC11Code": "73212-0085-11",
"ProductNDC": "73212-085",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gw-1516",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "GW-501516",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20-NOV-23"
},
{
"NDCCode": "70756-001-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-001-11) ",
"NDC11Code": "70756-0001-11",
"ProductNDC": "70756-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-002-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-002-11) ",
"NDC11Code": "70756-0002-11",
"ProductNDC": "70756-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-003-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-003-11) ",
"NDC11Code": "70756-0003-11",
"ProductNDC": "70756-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-004-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-004-11) ",
"NDC11Code": "70756-0004-11",
"ProductNDC": "70756-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-010-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-010-11) ",
"NDC11Code": "70756-0010-11",
"ProductNDC": "70756-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-011-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-011-11) ",
"NDC11Code": "70756-0011-11",
"ProductNDC": "70756-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-013-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-013-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0013-11",
"ProductNDC": "70756-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-014-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-014-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0014-11",
"ProductNDC": "70756-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-016-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-016-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0016-11",
"ProductNDC": "70756-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-020-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-020-11) ",
"NDC11Code": "70756-0020-11",
"ProductNDC": "70756-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-049-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-049-11) ",
"NDC11Code": "70756-0049-11",
"ProductNDC": "70756-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-050-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-050-11) ",
"NDC11Code": "70756-0050-11",
"ProductNDC": "70756-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-051-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-051-11) ",
"NDC11Code": "70756-0051-11",
"ProductNDC": "70756-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-052-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-052-11) ",
"NDC11Code": "70756-0052-11",
"ProductNDC": "70756-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-079-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-079-11) ",
"NDC11Code": "70756-0079-11",
"ProductNDC": "70756-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-080-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-080-11) ",
"NDC11Code": "70756-0080-11",
"ProductNDC": "70756-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-081-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-081-11) ",
"NDC11Code": "70756-0081-11",
"ProductNDC": "70756-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-094-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-094-11) ",
"NDC11Code": "70756-0094-11",
"ProductNDC": "70756-094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216663",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260127",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as, (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its molecular and structural formulae are. Molecular Formula: C16H21NO2 HCl. M.W. 295.80. Propranolol hydrochloride, USP is a stable, white to off-white crystalline powder which is soluble in water and in alcohol; slightly soluble in chloroform; practically insoluble in ether. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. Propranolol hydrochloride tablets, USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg contain the following inactive ingredients: anhydrous lactose, ascorbic acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 Phloxine Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and stearic acid. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-095-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-095-11) ",
"NDC11Code": "70756-0095-11",
"ProductNDC": "70756-095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216663",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260127",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as, (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its molecular and structural formulae are. Molecular Formula: C16H21NO2 HCl. M.W. 295.80. Propranolol hydrochloride, USP is a stable, white to off-white crystalline powder which is soluble in water and in alcohol; slightly soluble in chloroform; practically insoluble in ether. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. Propranolol hydrochloride tablets, USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg contain the following inactive ingredients: anhydrous lactose, ascorbic acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 Phloxine Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and stearic acid. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-201-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70756-201-11) ",
"NDC11Code": "70756-0201-11",
"ProductNDC": "70756-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213999",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210223",
"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 hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, crystalline powder or small crystals which is freely soluble in water, in alcohol, in chloroform, in methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, 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, USP. Inactive ingredients include ascorbic acid, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The 10 mg also includes D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide and xanthan gum 25 mg – D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 50 mg - D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, talc, titanium dioxide, and xanthan gum; 75 mg- FD&C blue #2 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 100 mg – D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 150 mg - FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>70756-085-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-085-11) </PackageDescription>
<NDC11Code>70756-0085-11</NDC11Code>
<ProductNDC>70756-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215885</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10202-085-01</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (10202-085-01)</PackageDescription>
<NDC11Code>10202-0085-01</NDC11Code>
<ProductNDC>10202-085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>7-11 Instant Hand Sanitizer With Aloe And Vitamin E</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>7-11</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>A hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>13107-085-11</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (13107-085-11) </PackageDescription>
<NDC11Code>13107-0085-11</NDC11Code>
<ProductNDC>13107-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203572</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33342-085-11</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-085-11) </PackageDescription>
<NDC11Code>33342-0085-11</NDC11Code>
<ProductNDC>33342-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203044</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: 1 Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-085-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (43598-085-25) > 1 mL in 1 VIAL (43598-085-11) </PackageDescription>
<NDC11Code>43598-0085-25</NDC11Code>
<ProductNDC>43598-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204485</ApplicationNumber>
<LabelerName>DR. REDDYS LABORATORIES INC</LabelerName>
<SubstanceName>VASOPRESSIN, UNSPECIFIED</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, 1.36 mg sodium acetate buffer and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are included to adjust to a pH of 3.8. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23. One mg is equivalent to 530 units.</Description>
</NDC>
<NDC>
<NDCCode>50268-085-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-085-15) > 1 TABLET in 1 BLISTER PACK (50268-085-11) </PackageDescription>
<NDC11Code>50268-0085-15</NDC11Code>
<ProductNDC>50268-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68084-085-21</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68084-085-21) > 10 TABLET in 1 BLISTER PACK (68084-085-11)</PackageDescription>
<NDC11Code>68084-0085-21</NDC11Code>
<ProductNDC>68084-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077414</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>70377-085-11</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70377-085-11) </PackageDescription>
<NDC11Code>70377-0085-11</NDC11Code>
<ProductNDC>70377-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217217</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib tablets are a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is soluble in N,N-dimethylformamide and insoluble in acetonitrile. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, administered orally, with the following inactive ingredients: anhydrous lactose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate. The tablet coating consists of polyvinyl alcohol, glycerol esters of fatty acids, talc, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71209-085-11</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (71209-085-11) </PackageDescription>
<NDC11Code>71209-0085-11</NDC11Code>
<ProductNDC>71209-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211325</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white to off-white powder, soluble in water and in alcohol. Insoluble in ether and in chloroform. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg or 300 mg of labetalol hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, opadry white, polysorbate, and sodium starch glycolate (potato). Opadry white contains hypromellose, polyethylene glycol, titanium dioxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>73212-085-11</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (73212-085-11) </PackageDescription>
<NDC11Code>73212-0085-11</NDC11Code>
<ProductNDC>73212-085</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gw-1516</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>GW-501516</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-NOV-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70756-001-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-001-11) </PackageDescription>
<NDC11Code>70756-0001-11</NDC11Code>
<ProductNDC>70756-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-002-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-002-11) </PackageDescription>
<NDC11Code>70756-0002-11</NDC11Code>
<ProductNDC>70756-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-003-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-003-11) </PackageDescription>
<NDC11Code>70756-0003-11</NDC11Code>
<ProductNDC>70756-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-004-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-004-11) </PackageDescription>
<NDC11Code>70756-0004-11</NDC11Code>
<ProductNDC>70756-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-010-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-010-11) </PackageDescription>
<NDC11Code>70756-0010-11</NDC11Code>
<ProductNDC>70756-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-011-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-011-11) </PackageDescription>
<NDC11Code>70756-0011-11</NDC11Code>
<ProductNDC>70756-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-013-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-013-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0013-11</NDC11Code>
<ProductNDC>70756-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-014-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-014-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0014-11</NDC11Code>
<ProductNDC>70756-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-016-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-016-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0016-11</NDC11Code>
<ProductNDC>70756-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-020-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-020-11) </PackageDescription>
<NDC11Code>70756-0020-11</NDC11Code>
<ProductNDC>70756-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-049-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-049-11) </PackageDescription>
<NDC11Code>70756-0049-11</NDC11Code>
<ProductNDC>70756-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-050-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-050-11) </PackageDescription>
<NDC11Code>70756-0050-11</NDC11Code>
<ProductNDC>70756-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-051-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-051-11) </PackageDescription>
<NDC11Code>70756-0051-11</NDC11Code>
<ProductNDC>70756-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-052-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-052-11) </PackageDescription>
<NDC11Code>70756-0052-11</NDC11Code>
<ProductNDC>70756-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-079-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-079-11) </PackageDescription>
<NDC11Code>70756-0079-11</NDC11Code>
<ProductNDC>70756-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-080-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-080-11) </PackageDescription>
<NDC11Code>70756-0080-11</NDC11Code>
<ProductNDC>70756-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-081-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-081-11) </PackageDescription>
<NDC11Code>70756-0081-11</NDC11Code>
<ProductNDC>70756-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-094-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-094-11) </PackageDescription>
<NDC11Code>70756-0094-11</NDC11Code>
<ProductNDC>70756-094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216663</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as, (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its molecular and structural formulae are. Molecular Formula: C16H21NO2 HCl. M.W. 295.80. Propranolol hydrochloride, USP is a stable, white to off-white crystalline powder which is soluble in water and in alcohol; slightly soluble in chloroform; practically insoluble in ether. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. Propranolol hydrochloride tablets, USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg contain the following inactive ingredients: anhydrous lactose, ascorbic acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 Phloxine Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and stearic acid. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-095-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-095-11) </PackageDescription>
<NDC11Code>70756-0095-11</NDC11Code>
<ProductNDC>70756-095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216663</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as, (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its molecular and structural formulae are. Molecular Formula: C16H21NO2 HCl. M.W. 295.80. Propranolol hydrochloride, USP is a stable, white to off-white crystalline powder which is soluble in water and in alcohol; slightly soluble in chloroform; practically insoluble in ether. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. Propranolol hydrochloride tablets, USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg contain the following inactive ingredients: anhydrous lactose, ascorbic acid, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 Phloxine Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and stearic acid. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-201-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70756-201-11) </PackageDescription>
<NDC11Code>70756-0201-11</NDC11Code>
<ProductNDC>70756-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213999</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210223</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 hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, crystalline powder or small crystals which is freely soluble in water, in alcohol, in chloroform, in methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, 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, USP. Inactive ingredients include ascorbic acid, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The 10 mg also includes D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide and xanthan gum 25 mg – D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 50 mg - D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, talc, titanium dioxide, and xanthan gum; 75 mg- FD&C blue #2 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 100 mg – D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 150 mg - FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>