{
"NDC": [
{
"NDCCode": "0378-7001-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) ",
"NDC11Code": "00378-7001-10",
"ProductNDC": "0378-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078902",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080324",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP (hemihydrate) is an odorless, white or almost white crystalline powder, having a melting point range of 129° to 131°C and a solubility of 5.4 mg/mL in water. Paroxetine TabletsParoxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg or 40 mg paroxetine equivalent to 11.38 mg, 22.76 mg, 34.14 mg or 45.52 mg of paroxetine hydrochloride hemihydrate, respectively. Inactive ingredients consist of dibasic calcium phosphate dihydrate, FD&C Blue No. 1 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate (potato), titanium dioxide and triacetin. Paroxetine Hydrochloride Meets USP Organic Impurities Test 1."
},
{
"NDCCode": "0378-7001-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-01)",
"NDC11Code": "00378-7001-01",
"ProductNDC": "0378-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078902",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-10-31"
},
{
"NDCCode": "0378-7001-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93) ",
"NDC11Code": "00378-7001-93",
"ProductNDC": "0378-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078902",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080324",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP (hemihydrate) is an odorless, white or almost white crystalline powder, having a melting point range of 129° to 131°C and a solubility of 5.4 mg/mL in water. Paroxetine TabletsParoxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg or 40 mg paroxetine equivalent to 11.38 mg, 22.76 mg, 34.14 mg or 45.52 mg of paroxetine hydrochloride hemihydrate, respectively. Inactive ingredients consist of dibasic calcium phosphate dihydrate, FD&C Blue No. 1 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate (potato), titanium dioxide and triacetin. Paroxetine Hydrochloride Meets USP Organic Impurities Test 1."
},
{
"NDCCode": "10819-7001-8",
"PackageDescription": "10 PACKET in 1 TRAY (10819-7001-8) > 38.3 mL in 1 PACKET",
"NDC11Code": "10819-7001-08",
"ProductNDC": "10819-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sani-hands For Kids",
"ProprietaryNameSuffix": "Antibacterial Moist Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Professional Disposables International, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50114-7001-6",
"PackageDescription": "10 VIAL in 1 CARTON (50114-7001-6) > 1.1 mL in 1 VIAL",
"NDC11Code": "50114-7001-06",
"ProductNDC": "50114-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gripp-heel",
"NonProprietaryName": "Aconitum Napellus And Bryonia Alba Root And Lachesis Muta Venom And Eupatorium Perfoliatum Flowering Top And Phosphorus",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Heel Inc",
"SubstanceName": "ACONITUM NAPELLUS; BRYONIA ALBA ROOT; LACHESIS MUTA VENOM; EUPATORIUM PERFOLIATUM FLOWERING TOP; PHOSPHORUS",
"StrengthNumber": "3; 3; 11; 2; 4",
"StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL",
"Status": "Deprecated",
"LastUpdate": "2017-02-24"
},
{
"NDCCode": "64644-7001-1",
"PackageDescription": "10 BOX in 1 BOX (64644-7001-1) > 4 POUCH in 1 BOX > 20 g in 1 POUCH",
"NDC11Code": "64644-7001-01",
"ProductNDC": "64644-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gelfos M",
"NonProprietaryName": "Aluminum Phosphate Gel, Magnesium Hydroxide, Simethicone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Boryung Pharmaceutical Co., Ltd.",
"SubstanceName": "DIMETHICONE; ALUMINUM PHOSPHATE; MAGNESIUM HYDROXIDE",
"StrengthNumber": ".04; 12.38; .4",
"StrengthUnit": "g/20g; g/20g; g/20g",
"Status": "Deprecated",
"LastUpdate": "2017-04-11"
},
{
"NDCCode": "0169-7010-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7010-01) * 1 mL in 1 VIAL, GLASS (0169-7017-11) * 1 mL in 1 VIAL, GLASS (0169-7001-98) ",
"NDC11Code": "00169-7010-01",
"ProductNDC": "0169-7010",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoseven",
"ProprietaryNameSuffix": "Rt",
"NonProprietaryName": "Coagulation Factor Viia (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20080430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103665",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080430",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.",
"Description": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT."
},
{
"NDCCode": "0268-7001-06",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-7001-06) ",
"NDC11Code": "00268-7001-06",
"ProductNDC": "0268-7001",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Mite D. Pteronyssinus",
"NonProprietaryName": "Standardized Mite D. Pteronyssinus",
"DosageFormName": "SOLUTION",
"RouteName": "PERCUTANEOUS",
"StartMarketingDate": "19900814",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103752",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "10000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900814",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus). used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material. Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive. In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract. For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter. This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy."
},
{
"NDCCode": "0904-7001-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7001-61) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00904-7001-61",
"ProductNDC": "0904-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210432",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190719",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "41525-7001-1",
"PackageDescription": "600 mL in 1 BOTTLE (41525-7001-1)",
"NDC11Code": "41525-7001-01",
"ProductNDC": "41525-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Gargle",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "DENTAL",
"StartMarketingDate": "20150122",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "PBS Co., Ltd.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".02",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out."
},
{
"NDCCode": "41525-7001-2",
"PackageDescription": "780 mL in 1 BOTTLE (41525-7001-2)",
"NDC11Code": "41525-7001-02",
"ProductNDC": "41525-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Gargle",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "DENTAL",
"StartMarketingDate": "20150122",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "PBS Co., Ltd.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".02",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out."
},
{
"NDCCode": "50436-7001-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50436-7001-1) ",
"NDC11Code": "50436-7001-01",
"ProductNDC": "50436-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021368",
"LabelerName": "Unit Dose Services",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190221",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "50436-7001-3",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50436-7001-3) ",
"NDC11Code": "50436-7001-03",
"ProductNDC": "50436-7001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021368",
"LabelerName": "Unit Dose Services",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190221",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "52345-7001-1",
"PackageDescription": "80 mL in 1 BOTTLE, PLASTIC (52345-7001-1) ",
"NDC11Code": "52345-7001-01",
"ProductNDC": "52345-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dream Eye",
"NonProprietaryName": "Poloxamer 407",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "K&J.C Co., Ltd",
"SubstanceName": "POLOXAMER 407",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "for opthalmic use.",
"Description": "Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended."
},
{
"NDCCode": "52345-7001-2",
"PackageDescription": "150 mL in 1 BOTTLE, PLASTIC (52345-7001-2) ",
"NDC11Code": "52345-7001-02",
"ProductNDC": "52345-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dream Eye",
"NonProprietaryName": "Poloxamer 407",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "K&J.C Co., Ltd",
"SubstanceName": "POLOXAMER 407",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "for opthalmic use.",
"Description": "Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended."
},
{
"NDCCode": "52345-7001-3",
"PackageDescription": "350 mL in 1 BOTTLE, PLASTIC (52345-7001-3) ",
"NDC11Code": "52345-7001-03",
"ProductNDC": "52345-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dream Eye",
"NonProprietaryName": "Poloxamer 407",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "K&J.C Co., Ltd",
"SubstanceName": "POLOXAMER 407",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "for opthalmic use.",
"Description": "Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended."
},
{
"NDCCode": "58066-7001-7",
"PackageDescription": "59.2 mL in 1 BOTTLE, SPRAY (58066-7001-7)",
"NDC11Code": "58066-7001-07",
"ProductNDC": "58066-7001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Free",
"NonProprietaryName": "Antimonium Tartaricum, Asterias Rubens, Ferrum Metallicum, Hepar Sulphuris Calcareum, Kali Bromatum, Lac Defloratum, Natrum Muriaticum, Sanguinaria Canadensis, Selenium Metallicum, Sepia, Silicea, Sulphur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Beaumont Bio Med",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SKIM MILK; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Indications: For temporary relief of: pimples & blemishes associated with acne."
},
{
"NDCCode": "0173-0378-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00173-0378-10",
"ProductNDC": "0173-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortaz",
"NonProprietaryName": "Ceftazidime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041213",
"EndMarketingDate": "20140420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050578",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFTAZIDIME SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "0378-0032-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) ",
"NDC11Code": "00378-0032-10",
"ProductNDC": "0378-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0047-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) ",
"NDC11Code": "00378-0047-10",
"ProductNDC": "0378-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0078-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)",
"NDC11Code": "00378-0078-10",
"ProductNDC": "0378-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090324",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0378-0080-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-10) ",
"NDC11Code": "00378-0080-10",
"ProductNDC": "0378-0080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indapamide",
"NonProprietaryName": "Indapamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074461",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "INDAPAMIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19960328",
"SamplePackage": "N",
"IndicationAndUsage": "Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.",
"Description": "Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin."
},
{
"NDCCode": "0378-0085-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0085-10)",
"NDC11Code": "00378-0085-10",
"ProductNDC": "0378-0085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090324",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0378-0137-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0378-0137-10) ",
"NDC11Code": "00378-0137-10",
"ProductNDC": "0378-0137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA018659",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861024",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0143-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-10) ",
"NDC11Code": "00378-0143-10",
"ProductNDC": "0378-0143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840420",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018858",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840420",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0152-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0152-10) ",
"NDC11Code": "00378-0152-10",
"ProductNDC": "0378-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870609",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070317",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19870609",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0182-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0182-10) ",
"NDC11Code": "00378-0182-10",
"ProductNDC": "0378-0182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"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 tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0183-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0183-10) ",
"NDC11Code": "00378-0183-10",
"ProductNDC": "0378-0183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"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 tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0184-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0184-10) ",
"NDC11Code": "00378-0184-10",
"ProductNDC": "0378-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"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 tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0186-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0186-10) ",
"NDC11Code": "00378-0186-10",
"ProductNDC": "0378-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870609",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070317",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19870609",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>0378-7001-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) </PackageDescription>
<NDC11Code>00378-7001-10</NDC11Code>
<ProductNDC>0378-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP (hemihydrate) is an odorless, white or almost white crystalline powder, having a melting point range of 129° to 131°C and a solubility of 5.4 mg/mL in water. Paroxetine TabletsParoxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg or 40 mg paroxetine equivalent to 11.38 mg, 22.76 mg, 34.14 mg or 45.52 mg of paroxetine hydrochloride hemihydrate, respectively. Inactive ingredients consist of dibasic calcium phosphate dihydrate, FD&C Blue No. 1 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate (potato), titanium dioxide and triacetin. Paroxetine Hydrochloride Meets USP Organic Impurities Test 1.</Description>
</NDC>
<NDC>
<NDCCode>0378-7001-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-01)</PackageDescription>
<NDC11Code>00378-7001-01</NDC11Code>
<ProductNDC>0378-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078902</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-7001-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93) </PackageDescription>
<NDC11Code>00378-7001-93</NDC11Code>
<ProductNDC>0378-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078902</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP (hemihydrate) is an odorless, white or almost white crystalline powder, having a melting point range of 129° to 131°C and a solubility of 5.4 mg/mL in water. Paroxetine TabletsParoxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg or 40 mg paroxetine equivalent to 11.38 mg, 22.76 mg, 34.14 mg or 45.52 mg of paroxetine hydrochloride hemihydrate, respectively. Inactive ingredients consist of dibasic calcium phosphate dihydrate, FD&C Blue No. 1 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate (potato), titanium dioxide and triacetin. Paroxetine Hydrochloride Meets USP Organic Impurities Test 1.</Description>
</NDC>
<NDC>
<NDCCode>10819-7001-8</NDCCode>
<PackageDescription>10 PACKET in 1 TRAY (10819-7001-8) > 38.3 mL in 1 PACKET</PackageDescription>
<NDC11Code>10819-7001-08</NDC11Code>
<ProductNDC>10819-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sani-hands For Kids</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial Moist Wipes</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Professional Disposables International, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50114-7001-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50114-7001-6) > 1.1 mL in 1 VIAL</PackageDescription>
<NDC11Code>50114-7001-06</NDC11Code>
<ProductNDC>50114-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gripp-heel</ProprietaryName>
<NonProprietaryName>Aconitum Napellus And Bryonia Alba Root And Lachesis Muta Venom And Eupatorium Perfoliatum Flowering Top And Phosphorus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930131</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Heel Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BRYONIA ALBA ROOT; LACHESIS MUTA VENOM; EUPATORIUM PERFOLIATUM FLOWERING TOP; PHOSPHORUS</SubstanceName>
<StrengthNumber>3; 3; 11; 2; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>64644-7001-1</NDCCode>
<PackageDescription>10 BOX in 1 BOX (64644-7001-1) > 4 POUCH in 1 BOX > 20 g in 1 POUCH</PackageDescription>
<NDC11Code>64644-7001-01</NDC11Code>
<ProductNDC>64644-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gelfos M</ProprietaryName>
<NonProprietaryName>Aluminum Phosphate Gel, Magnesium Hydroxide, Simethicone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Boryung Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>DIMETHICONE; ALUMINUM PHOSPHATE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>.04; 12.38; .4</StrengthNumber>
<StrengthUnit>g/20g; g/20g; g/20g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0169-7010-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7010-01) * 1 mL in 1 VIAL, GLASS (0169-7017-11) * 1 mL in 1 VIAL, GLASS (0169-7001-98) </PackageDescription>
<NDC11Code>00169-7010-01</NDC11Code>
<ProductNDC>0169-7010</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoseven</ProprietaryName>
<ProprietaryNameSuffix>Rt</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Viia (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20080430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103665</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.</IndicationAndUsage>
<Description>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT.</Description>
</NDC>
<NDC>
<NDCCode>0268-7001-06</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-7001-06) </PackageDescription>
<NDC11Code>00268-7001-06</NDC11Code>
<ProductNDC>0268-7001</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Mite D. Pteronyssinus</ProprietaryName>
<NonProprietaryName>Standardized Mite D. Pteronyssinus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS</RouteName>
<StartMarketingDate>19900814</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103752</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus). used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material. Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive. In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract. For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter. This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy.</Description>
</NDC>
<NDC>
<NDCCode>0904-7001-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7001-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7001-61</NDC11Code>
<ProductNDC>0904-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210432</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>41525-7001-1</NDCCode>
<PackageDescription>600 mL in 1 BOTTLE (41525-7001-1)</PackageDescription>
<NDC11Code>41525-7001-01</NDC11Code>
<ProductNDC>41525-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Gargle</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20150122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>PBS Co., Ltd.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.02</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41525-7001-2</NDCCode>
<PackageDescription>780 mL in 1 BOTTLE (41525-7001-2)</PackageDescription>
<NDC11Code>41525-7001-02</NDC11Code>
<ProductNDC>41525-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Gargle</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20150122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>PBS Co., Ltd.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.02</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50436-7001-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50436-7001-1) </PackageDescription>
<NDC11Code>50436-7001-01</NDC11Code>
<ProductNDC>50436-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Unit Dose Services</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>50436-7001-3</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50436-7001-3) </PackageDescription>
<NDC11Code>50436-7001-03</NDC11Code>
<ProductNDC>50436-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Unit Dose Services</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>52345-7001-1</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE, PLASTIC (52345-7001-1) </PackageDescription>
<NDC11Code>52345-7001-01</NDC11Code>
<ProductNDC>52345-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dream Eye</ProprietaryName>
<NonProprietaryName>Poloxamer 407</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>K&J.C Co., Ltd</LabelerName>
<SubstanceName>POLOXAMER 407</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for opthalmic use.</IndicationAndUsage>
<Description>Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended.</Description>
</NDC>
<NDC>
<NDCCode>52345-7001-2</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, PLASTIC (52345-7001-2) </PackageDescription>
<NDC11Code>52345-7001-02</NDC11Code>
<ProductNDC>52345-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dream Eye</ProprietaryName>
<NonProprietaryName>Poloxamer 407</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>K&J.C Co., Ltd</LabelerName>
<SubstanceName>POLOXAMER 407</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for opthalmic use.</IndicationAndUsage>
<Description>Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended.</Description>
</NDC>
<NDC>
<NDCCode>52345-7001-3</NDCCode>
<PackageDescription>350 mL in 1 BOTTLE, PLASTIC (52345-7001-3) </PackageDescription>
<NDC11Code>52345-7001-03</NDC11Code>
<ProductNDC>52345-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dream Eye</ProprietaryName>
<NonProprietaryName>Poloxamer 407</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>K&J.C Co., Ltd</LabelerName>
<SubstanceName>POLOXAMER 407</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for opthalmic use.</IndicationAndUsage>
<Description>Instructions for use (IFU) Cleans, Rinses, Disinfects, Stores and Removes Protein Daily. All Steps In One Bottle. Directions: To clean, disinfect and remove protein daily, complete these simple steps: STEP 1: Place 3 drops of Dream Eye on each side of contact lens and rub for 20 seconds. No necessary. separate daily cleaner STEP 2: Remove surface debris by rinsing thoroughly with Dream Eye STEP 3: Place cleaned contact lens in the lens case and fill with fresh Dream Eye MPS. Soak at least four(4) hours. CONTENTS: Dream Eye is a sterile, isotonic, buffered solution that contains poloxamer, sodium borate, sodium chloride; preserved with Polyhexamethylenebiguanide. ACTIONS: Cleans, loosens and removes accumulations of film, deposits and debris from soft contact lenses. Destroys harmful micro-organisms on the surface of the lens. Rinse, stores and rewets lenses before insertion. For dissolving of Enzymatic Contact Lens Cleaner tablets for removal of protein deposits. INDICATIONS(Uses): Dream Eye is indicated for use in daily cleaning, dissolving ofEnzymatic Contact Lens Cleaner tablets, rinsing and storage of daily and extended wear soft contact lenses and chemical (not heat) disinfection, as recommended by your eye care professional. CONTRAINDICATIONS (Reasons not to use): If you are allergic to any ingredient in Dream Eye, do not use this product. WARNING: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions for proper use and care of your lenses and lens care products, including the lens case. ☞ To avoid contamination, do not touch tip of container to any surface. Replace cap after using. ☞ Not intended for use directly in the eye. ☞ Not for use with heat(thermal) disinfection. PRECAUTIONS: ☞ Never re-use this solution. ☞ Keep the bottle tightly closed when not in use. ☞ Store at room temperature. ☞ Use before the expiration date marked on the bottle and carton. ☞ Keep out of the reach of childrenADVERSE REACTIONS (Problems and what to do): The following problems may occur: eyes sting, burn or itch (irritation), comfort is less than when lens wasfirst placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes. If you notice any of the above: ☞ IMMEDIATELY REMOVE YOUR LENSES. ☞ If the discomfort or problem stops, then look closely at the lens. ☞ If the lens is in any way damaged, DO NOT put the lens back on your eye. Place t he lens in the storage case and contact your eye care practitioner. ☞ If the lens has dirt, an eyelash, or other foreigh body on it, or the problem stops and the lens appears undamaged, thoroughly clean, rinse, and disinfect the lens, then reinsert it. ☞ If the problem continues, IMMEDIATELY remove the lens and consult your eye care practitioner. If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage. GOOD LENS CARE PRACTICES: ☞ Always wash and rinse your hands before you handle your lenses. ☞ Clean, rinse and disinfect your lenses each time you remove them.☞ Always handle the same lens, the right or left, first in order to avoid mix-ups. ☞ After use, always empty and rinse lens case with fresh rinsing solution and allow to air dry. DIRECTIONS: ☞ After removing the lens, place it in the palm of your hand, and place three drops of Daily Cleaner on each lens surface. or Soak at least four(4) hours in Dream Eye. ☞ Rub the lens for 20 seconds either in the palm of your hand using the forefinger of the other hand, or between the thumb and forefinger. Be sure to clean each side of the lens. ☞ Rinse the lens thoroughly by holding the lens in a steady stream of saline solution for approximately 10 seconds. ☞ Disinfect using the procedure which your practitioner has recommended.</Description>
</NDC>
<NDC>
<NDCCode>58066-7001-7</NDCCode>
<PackageDescription>59.2 mL in 1 BOTTLE, SPRAY (58066-7001-7)</PackageDescription>
<NDC11Code>58066-7001-07</NDC11Code>
<ProductNDC>58066-7001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Free</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Asterias Rubens, Ferrum Metallicum, Hepar Sulphuris Calcareum, Kali Bromatum, Lac Defloratum, Natrum Muriaticum, Sanguinaria Canadensis, Selenium Metallicum, Sepia, Silicea, Sulphur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Beaumont Bio Med</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SKIM MILK; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of: pimples & blemishes associated with acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0173-0378-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00173-0378-10</NDC11Code>
<ProductNDC>0173-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortaz</ProprietaryName>
<NonProprietaryName>Ceftazidime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041213</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050578</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFTAZIDIME SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0032-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) </PackageDescription>
<NDC11Code>00378-0032-10</NDC11Code>
<ProductNDC>0378-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0047-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) </PackageDescription>
<NDC11Code>00378-0047-10</NDC11Code>
<ProductNDC>0378-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0078-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)</PackageDescription>
<NDC11Code>00378-0078-10</NDC11Code>
<ProductNDC>0378-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090324</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0080-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-10) </PackageDescription>
<NDC11Code>00378-0080-10</NDC11Code>
<ProductNDC>0378-0080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indapamide</ProprietaryName>
<NonProprietaryName>Indapamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074461</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDAPAMIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.</IndicationAndUsage>
<Description>Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0378-0085-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0085-10)</PackageDescription>
<NDC11Code>00378-0085-10</NDC11Code>
<ProductNDC>0378-0085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090324</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0137-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0378-0137-10) </PackageDescription>
<NDC11Code>00378-0137-10</NDC11Code>
<ProductNDC>0378-0137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA018659</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-0143-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-10) </PackageDescription>
<NDC11Code>00378-0143-10</NDC11Code>
<ProductNDC>0378-0143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840420</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018858</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19840420</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0152-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0152-10) </PackageDescription>
<NDC11Code>00378-0152-10</NDC11Code>
<ProductNDC>0378-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870609</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070317</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19870609</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0182-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0182-10) </PackageDescription>
<NDC11Code>00378-0182-10</NDC11Code>
<ProductNDC>0378-0182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070213</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</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>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851119</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 tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
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<LabelerName>Mylan Pharmaceuticals Inc.</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>2026-03-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<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 tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StartMarketingDatePackage>19851119</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 tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
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<ProductNDC>0378-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19870609</StartMarketingDatePackage>
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