{
"NDC": [
{
"NDCCode": "67046-0630-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0630-3) ",
"NDC11Code": "67046-0630-03",
"ProductNDC": "67046-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201003",
"LabelerName": "Coupler LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260423",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) , 3 Treatment of irritability associated with autistic disorder ( 1.3) .",
"Description": "Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.49. The structural formula is:. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 NHCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red."
},
{
"NDCCode": "15631-0630-3",
"PackageDescription": "100 TABLET in 1 CONTAINER (15631-0630-3)",
"NDC11Code": "15631-0630-03",
"ProductNDC": "15631-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Phosphorica",
"NonProprietaryName": "Magnesia Phosphorica",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151207",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0630-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0630-3) ",
"NDC11Code": "37662-0630-03",
"ProductNDC": "37662-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dioscorea Villosa",
"NonProprietaryName": "Dioscorea Villosa",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220617",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "DIOSCOREA VILLOSA TUBER",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220617",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0630-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0630-3)",
"NDC11Code": "49288-0630-03",
"ProductNDC": "49288-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bitter Dock",
"NonProprietaryName": "Bitter Dock",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "RUMEX OBTUSIFOLIUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "58443-0630-3",
"PackageDescription": "100 mL in 1 TUBE (58443-0630-3) ",
"NDC11Code": "58443-0630-03",
"ProductNDC": "58443-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230804",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Prime Enterprises, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30.09; 75.23; 50.15; 50.15",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230804",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "68108-0630-1",
"PackageDescription": "3 kg in 1 DRUM (68108-0630-1) ",
"NDC11Code": "68108-0630-01",
"ProductNDC": "68108-0630",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121002",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SCI Pharmtech, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "02-OCT-12"
},
{
"NDCCode": "71335-0630-3",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3) ",
"NDC11Code": "71335-0630-03",
"ProductNDC": "71335-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180724",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate) is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0135-0630-01",
"PackageDescription": "60 TABLET, CHEWABLE in 1 CONTAINER (0135-0630-01) ",
"NDC11Code": "00135-0630-01",
"ProductNDC": "0135-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tums Chewy Bites",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "0378-0630-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0378-0630-01) ",
"NDC11Code": "00378-0630-01",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0378-0630-88",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0378-0630-88) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00378-0630-88",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0378-0630-91",
"PackageDescription": "60 TABLET in 1 BOTTLE (0378-0630-91) ",
"NDC11Code": "00378-0630-91",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0832-0630-11",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0832-0630-11) ",
"NDC11Code": "00832-0630-11",
"ProductNDC": "0832-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074953",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10."
},
{
"NDCCode": "0998-0630-06",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (0998-0630-06) ",
"NDC11Code": "00998-0630-06",
"ProductNDC": "0998-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxitrol",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19641115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050023",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "1; 3.5; 10000",
"StrengthUnit": "mg/mL; mg/mL; [USP'U]/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19641115",
"SamplePackage": "N",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.",
"Description": "MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. C22H29FO5. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride."
},
{
"NDCCode": "10135-630-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-630-01) ",
"NDC11Code": "10135-0630-01",
"ProductNDC": "10135-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Acebutolol HCl, USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol HCl capsules, USP are provided in two dosage strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, maize starch, povidone, stearic acid and titanium dioxide. Acebutolol HCl, USP has the following structural formula. C18 H28 N2 O4 HCl M.W. 372.89. Acebutolol HCl, USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2- hydroxy-3-[(1-methylethyl) amino] propoxy] phenyl] butanamide."
},
{
"NDCCode": "10893-630-04",
"PackageDescription": "113.3 g in 1 PACKAGE (10893-630-04) ",
"NDC11Code": "10893-0630-04",
"ProductNDC": "10893-630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil",
"ProprietaryNameSuffix": "Nail Fungus",
"NonProprietaryName": "Sulfur And Thuja Occidentalis",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1; 6",
"StrengthUnit": "[hp_X]/127.6g; [hp_X]/127.6g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Symptomatic homeopathic topical treatment of common fungal and parasitic skin conditions and nail fungus.",
"Description": "The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States."
},
{
"NDCCode": "13668-630-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (13668-630-60) ",
"NDC11Code": "13668-0630-60",
"ProductNDC": "13668-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitisinone",
"NonProprietaryName": "Nitisinone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215908",
"LabelerName": "Torrent pharmaceuticals limited",
"SubstanceName": "NITISINONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230109",
"SamplePackage": "N",
"IndicationAndUsage": "Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.",
"Description": "Nitisinone capsules contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol. Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is. Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23. Capsules: Hard, white-opaque capsule, marked as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone, intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg nitisinone and pre-gelatinized maize starch. The capsule shell is gelatin and titanium dioxide and the imprint is Shellac-NF-E904 and FD & C Blue #2 Aluminium lake – E132 (Indigo Carmine), propylene glycol and strong ammonia solution."
},
{
"NDCCode": "16714-630-01",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-630-01) ",
"NDC11Code": "16714-0630-01",
"ProductNDC": "16714-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078490",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells have the following inactive ingredients: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "17856-0630-1",
"PackageDescription": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0630-1) / 30 mL in 1 CUP, UNIT-DOSE",
"NDC11Code": "17856-0630-01",
"ProductNDC": "17856-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Geri-lanta Antacid Antigas",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "200; 200; 20",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 the symptoms referred to as gas."
},
{
"NDCCode": "24208-630-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-630-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0630-05",
"ProductNDC": "24208-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bepotastine Besilate",
"NonProprietaryName": "Bepotastine Besilate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022288",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "BEPOTASTINE BESILATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.",
"Description": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: : 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) , 2 Inactives:monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP., 3 Preservative: benzalkonium chloride 0.005%."
},
{
"NDCCode": "24208-630-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-630-10) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0630-10",
"ProductNDC": "24208-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bepotastine Besilate",
"NonProprietaryName": "Bepotastine Besilate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022288",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "BEPOTASTINE BESILATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.",
"Description": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: : 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) , 2 Inactives:monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP., 3 Preservative: benzalkonium chloride 0.005%."
},
{
"NDCCode": "30698-630-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (30698-630-01) ",
"NDC11Code": "30698-0630-01",
"ProductNDC": "30698-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumex",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018225",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830228",
"SamplePackage": "N",
"IndicationAndUsage": "Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumex ®(bumetanide) is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red iron oxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA-approved impurity specifications differ from the USP."
},
{
"NDCCode": "31722-630-31",
"PackageDescription": "10 CAPSULE in 1 CARTON (31722-630-31) ",
"NDC11Code": "31722-0630-31",
"ProductNDC": "31722-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2018-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180223",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "42192-630-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (42192-630-04) ",
"NDC11Code": "42192-0630-04",
"ProductNDC": "42192-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203375",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration."
},
{
"NDCCode": "42192-630-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (42192-630-16) ",
"NDC11Code": "42192-0630-16",
"ProductNDC": "42192-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203375",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration."
},
{
"NDCCode": "42947-630-03",
"PackageDescription": "1.4 mL in 1 POUCH (42947-630-03)",
"NDC11Code": "42947-0630-03",
"ProductNDC": "42947-630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obstetrical Antiseptic",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Wuxi Medical Instrument Factory",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".0013",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions. * Clean the affected area. * Apply a small amount of this product on the area 1 to 3 times daily. * May be covered with a sterile bandage when dry."
},
{
"NDCCode": "43063-630-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30) ",
"NDC11Code": "43063-0630-30",
"ProductNDC": "43063-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078181",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151029",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies( 14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, sodium starch glycolate, povidone, and magnesium stearate. In addition, glimepiride tablets, USP 1 mg contain ferric oxide red, glimepiride tablets, USP 2 mg contain ferric oxide yellow and FD &C blue #2 aluminum lake, and glimepiride tablets, USP 4 mg contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "43063-630-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90) ",
"NDC11Code": "43063-0630-90",
"ProductNDC": "43063-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078181",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151029",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies( 14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, sodium starch glycolate, povidone, and magnesium stearate. In addition, glimepiride tablets, USP 1 mg contain ferric oxide red, glimepiride tablets, USP 2 mg contain ferric oxide yellow and FD &C blue #2 aluminum lake, and glimepiride tablets, USP 4 mg contain FD&C blue #2 aluminum lake."
},
{
"NDCCode": "43857-0630-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0630-1) ",
"NDC11Code": "43857-0630-01",
"ProductNDC": "43857-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Enviroforce",
"NonProprietaryName": "Sarsaparilla (smilax Regelii), Xanthoxylum Fraxineum, Phytolacca Decandra, Hydrastis Canadensis, Aurum Metallicum, Carbo Animalis, Causticum, Iodium, Sulphur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20230410",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "SMILAX ORNATA ROOT; ZANTHOXYLUM AMERICANUM BARK; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; GOLD; CARBO ANIMALIS; CAUSTICUM; IODINE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "3; 3; 4; 5; 12; 12; 12; 12; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230410",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor pains, skin irritations, & minor swellings in joints with heat."
},
{
"NDCCode": "44911-0630-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (44911-0630-1) ",
"NDC11Code": "44911-0630-01",
"ProductNDC": "44911-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Additivestat",
"NonProprietaryName": "Trifolium Pratense, Petroleum, Phytolacca Decandra, Arsenicum Album, Chelidonium Majus, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Nitricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Energique, Inc.",
"SubstanceName": "TRIFOLIUM PRATENSE FLOWER; KEROSENE; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS WHOLE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; NITRIC ACID",
"StrengthNumber": "3; 6; 6; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve debility, exhaustion after slight exertion, and nausea.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "47781-630-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-630-01) ",
"NDC11Code": "47781-0630-01",
"ProductNDC": "47781-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204595",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see WARNINGS). Felbamate tablets are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, Felbamate tablets can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-Phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4; its structural formula is. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67046-0630-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0630-3) </PackageDescription>
<NDC11Code>67046-0630-03</NDC11Code>
<ProductNDC>67046-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201003</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) , 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
<Description>Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.49. The structural formula is:. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 NHCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>15631-0630-3</NDCCode>
<PackageDescription>100 TABLET in 1 CONTAINER (15631-0630-3)</PackageDescription>
<NDC11Code>15631-0630-03</NDC11Code>
<ProductNDC>15631-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesia Phosphorica</ProprietaryName>
<NonProprietaryName>Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0630-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0630-3) </PackageDescription>
<NDC11Code>37662-0630-03</NDC11Code>
<ProductNDC>37662-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dioscorea Villosa</ProprietaryName>
<NonProprietaryName>Dioscorea Villosa</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>DIOSCOREA VILLOSA TUBER</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0630-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0630-3)</PackageDescription>
<NDC11Code>49288-0630-03</NDC11Code>
<ProductNDC>49288-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bitter Dock</ProprietaryName>
<NonProprietaryName>Bitter Dock</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>RUMEX OBTUSIFOLIUS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>58443-0630-3</NDCCode>
<PackageDescription>100 mL in 1 TUBE (58443-0630-3) </PackageDescription>
<NDC11Code>58443-0630-03</NDC11Code>
<ProductNDC>58443-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Prime Enterprises, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30.09; 75.23; 50.15; 50.15</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68108-0630-1</NDCCode>
<PackageDescription>3 kg in 1 DRUM (68108-0630-1) </PackageDescription>
<NDC11Code>68108-0630-01</NDC11Code>
<ProductNDC>68108-0630</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121002</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SCI Pharmtech, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-OCT-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71335-0630-3</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3) </PackageDescription>
<NDC11Code>71335-0630-03</NDC11Code>
<ProductNDC>71335-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate) is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0135-0630-01</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 CONTAINER (0135-0630-01) </PackageDescription>
<NDC11Code>00135-0630-01</NDC11Code>
<ProductNDC>0135-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tums Chewy Bites</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-0630-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0378-0630-01) </PackageDescription>
<NDC11Code>00378-0630-01</NDC11Code>
<ProductNDC>0378-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
</NDC>
<NDC>
<NDCCode>0378-0630-88</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0378-0630-88) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-0630-88</NDC11Code>
<ProductNDC>0378-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
</NDC>
<NDC>
<NDCCode>0378-0630-91</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0378-0630-91) </PackageDescription>
<NDC11Code>00378-0630-91</NDC11Code>
<ProductNDC>0378-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
</NDC>
<NDC>
<NDCCode>0832-0630-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0832-0630-11) </PackageDescription>
<NDC11Code>00832-0630-11</NDC11Code>
<ProductNDC>0832-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074953</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10.</Description>
</NDC>
<NDC>
<NDCCode>0998-0630-06</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (0998-0630-06) </PackageDescription>
<NDC11Code>00998-0630-06</NDC11Code>
<ProductNDC>0998-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxitrol</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19641115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050023</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>1; 3.5; 10000</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; [USP'U]/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. C22H29FO5. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>10135-630-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (10135-630-01) </PackageDescription>
<NDC11Code>10135-0630-01</NDC11Code>
<ProductNDC>10135-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Acebutolol HCl, USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol HCl capsules, USP are provided in two dosage strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, maize starch, povidone, stearic acid and titanium dioxide. Acebutolol HCl, USP has the following structural formula. C18 H28 N2 O4 HCl M.W. 372.89. Acebutolol HCl, USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2- hydroxy-3-[(1-methylethyl) amino] propoxy] phenyl] butanamide.</Description>
</NDC>
<NDC>
<NDCCode>10893-630-04</NDCCode>
<PackageDescription>113.3 g in 1 PACKAGE (10893-630-04) </PackageDescription>
<NDC11Code>10893-0630-04</NDC11Code>
<ProductNDC>10893-630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil</ProprietaryName>
<ProprietaryNameSuffix>Nail Fungus</ProprietaryNameSuffix>
<NonProprietaryName>Sulfur And Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/127.6g; [hp_X]/127.6g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Symptomatic homeopathic topical treatment of common fungal and parasitic skin conditions and nail fungus.</IndicationAndUsage>
<Description>The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.</Description>
</NDC>
<NDC>
<NDCCode>13668-630-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (13668-630-60) </PackageDescription>
<NDC11Code>13668-0630-60</NDC11Code>
<ProductNDC>13668-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitisinone</ProprietaryName>
<NonProprietaryName>Nitisinone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215908</ApplicationNumber>
<LabelerName>Torrent pharmaceuticals limited</LabelerName>
<SubstanceName>NITISINONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.</IndicationAndUsage>
<Description>Nitisinone capsules contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol. Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is. Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23. Capsules: Hard, white-opaque capsule, marked as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone, intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg nitisinone and pre-gelatinized maize starch. The capsule shell is gelatin and titanium dioxide and the imprint is Shellac-NF-E904 and FD & C Blue #2 Aluminium lake – E132 (Indigo Carmine), propylene glycol and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>16714-630-01</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-630-01) </PackageDescription>
<NDC11Code>16714-0630-01</NDC11Code>
<ProductNDC>16714-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078490</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells have the following inactive ingredients: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>17856-0630-1</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0630-1) / 30 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0630-01</NDC11Code>
<ProductNDC>17856-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Geri-lanta Antacid Antigas</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>200; 200; 20</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 the symptoms referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24208-630-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-630-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0630-05</NDC11Code>
<ProductNDC>24208-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bepotastine Besilate</ProprietaryName>
<NonProprietaryName>Bepotastine Besilate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022288</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>BEPOTASTINE BESILATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.</IndicationAndUsage>
<Description>Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: : 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) , 2 Inactives:monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP., 3 Preservative: benzalkonium chloride 0.005%.</Description>
</NDC>
<NDC>
<NDCCode>24208-630-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-630-10) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0630-10</NDC11Code>
<ProductNDC>24208-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bepotastine Besilate</ProprietaryName>
<NonProprietaryName>Bepotastine Besilate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022288</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>BEPOTASTINE BESILATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.</IndicationAndUsage>
<Description>Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: : 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) , 2 Inactives:monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP., 3 Preservative: benzalkonium chloride 0.005%.</Description>
</NDC>
<NDC>
<NDCCode>30698-630-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (30698-630-01) </PackageDescription>
<NDC11Code>30698-0630-01</NDC11Code>
<ProductNDC>30698-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumex</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018225</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumex ®(bumetanide) is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red iron oxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA-approved impurity specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-630-31</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (31722-630-31) </PackageDescription>
<NDC11Code>31722-0630-31</NDC11Code>
<ProductNDC>31722-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2018-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>42192-630-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (42192-630-04) </PackageDescription>
<NDC11Code>42192-0630-04</NDC11Code>
<ProductNDC>42192-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203375</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>42192-630-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (42192-630-16) </PackageDescription>
<NDC11Code>42192-0630-16</NDC11Code>
<ProductNDC>42192-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203375</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, colorless, sugar free syrup. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP . . . . . . . . 2 mg. Pseudoephedrine Hydrochloride, USP . . . . . 30 mg. Dextromethorphan Hydrobromide, USP . . . 10 mg. Inactive Ingredients: citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. C 16H 19BrN 2C 4H 4O 4 M.W. 435.31 Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1). C 10H 15NOHCl M.W. 201.69 Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride. C 18H 25NOHBrH 2O M.W. 370.32 Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate. Antihistamine/ Nasal Decongestant/ Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>42947-630-03</NDCCode>
<PackageDescription>1.4 mL in 1 POUCH (42947-630-03)</PackageDescription>
<NDC11Code>42947-0630-03</NDC11Code>
<ProductNDC>42947-630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obstetrical Antiseptic</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Wuxi Medical Instrument Factory</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.0013</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. * Clean the affected area. * Apply a small amount of this product on the area 1 to 3 times daily. * May be covered with a sterile bandage when dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-630-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-630-30) </PackageDescription>
<NDC11Code>43063-0630-30</NDC11Code>
<ProductNDC>43063-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078181</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies( 14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, sodium starch glycolate, povidone, and magnesium stearate. In addition, glimepiride tablets, USP 1 mg contain ferric oxide red, glimepiride tablets, USP 2 mg contain ferric oxide yellow and FD &C blue #2 aluminum lake, and glimepiride tablets, USP 4 mg contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>43063-630-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43063-630-90) </PackageDescription>
<NDC11Code>43063-0630-90</NDC11Code>
<ProductNDC>43063-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078181</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies( 14.1)]. Limitations of Use. Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets, USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, sodium starch glycolate, povidone, and magnesium stearate. In addition, glimepiride tablets, USP 1 mg contain ferric oxide red, glimepiride tablets, USP 2 mg contain ferric oxide yellow and FD &C blue #2 aluminum lake, and glimepiride tablets, USP 4 mg contain FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>43857-0630-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0630-1) </PackageDescription>
<NDC11Code>43857-0630-01</NDC11Code>
<ProductNDC>43857-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Enviroforce</ProprietaryName>
<NonProprietaryName>Sarsaparilla (smilax Regelii), Xanthoxylum Fraxineum, Phytolacca Decandra, Hydrastis Canadensis, Aurum Metallicum, Carbo Animalis, Causticum, Iodium, Sulphur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230410</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>SMILAX ORNATA ROOT; ZANTHOXYLUM AMERICANUM BARK; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; GOLD; CARBO ANIMALIS; CAUSTICUM; IODINE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 3; 4; 5; 12; 12; 12; 12; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor pains, skin irritations, & minor swellings in joints with heat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44911-0630-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (44911-0630-1) </PackageDescription>
<NDC11Code>44911-0630-01</NDC11Code>
<ProductNDC>44911-0630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Additivestat</ProprietaryName>
<NonProprietaryName>Trifolium Pratense, Petroleum, Phytolacca Decandra, Arsenicum Album, Chelidonium Majus, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Nitricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Energique, Inc.</LabelerName>
<SubstanceName>TRIFOLIUM PRATENSE FLOWER; KEROSENE; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS WHOLE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; NITRIC ACID</SubstanceName>
<StrengthNumber>3; 6; 6; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve debility, exhaustion after slight exertion, and nausea.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47781-630-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-630-01) </PackageDescription>
<NDC11Code>47781-0630-01</NDC11Code>
<ProductNDC>47781-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204595</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see WARNINGS). Felbamate tablets are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, Felbamate tablets can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-Phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4; its structural formula is. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
</NDCList>