{
"NDC": [
{
"NDCCode": "63187-400-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-400-04) ",
"NDC11Code": "63187-0400-04",
"ProductNDC": "63187-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphanhydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20100615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088811",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "2; 10; 30",
"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": "Deprecated",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "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 Oral Syrup is a clear, light pink syrup with a butterscotch flavor. Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration."
},
{
"NDCCode": "63187-007-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (63187-007-04) ",
"NDC11Code": "63187-0007-04",
"ProductNDC": "63187-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065225",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220317",
"SamplePackage": "N",
"IndicationAndUsage": "Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: 1 patients with cystic fibrosis,, 2 patients with nosocomially acquired infections,, 3 patients with known or suspected bacteremia,, 4 patients requiring hospitalization,, 5 elderly or debilitated patients, or, 6 patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide. The 500 mg tablets also contain FD&C blue #2."
},
{
"NDCCode": "63187-035-04",
"PackageDescription": "4 TABLET in 1 BOTTLE (63187-035-04) ",
"NDC11Code": "63187-0035-04",
"ProductNDC": "63187-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070033",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2024-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211214",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole Tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).",
"Description": "Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1H-Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula. C6H9N3O3 M.W. 171.15. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil."
},
{
"NDCCode": "63187-040-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-040-04) ",
"NDC11Code": "63187-0040-04",
"ProductNDC": "63187-040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q Tussin Dm",
"NonProprietaryName": "Dextromethorphan Hbr And Guaifenesin",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19950401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
},
{
"NDCCode": "63187-117-04",
"PackageDescription": "118 mL in 1 BOTTLE (63187-117-04) ",
"NDC11Code": "63187-0117-04",
"ProductNDC": "63187-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Codeine Phosphate",
"NonProprietaryName": "Guaifenesin And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20061001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CODEINE PHOSPHATE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.",
"Description": "Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg. Inactive Ingredients: Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol. Sodium Content: 5 mg/5 mL. Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ."
},
{
"NDCCode": "63187-136-04",
"PackageDescription": "50 BOTTLE in 1 CARTON (63187-136-04) / 120 mL in 1 BOTTLE",
"NDC11Code": "63187-0136-04",
"ProductNDC": "63187-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dendracin Neurodendraxcin",
"NonProprietaryName": "Methyl Salicylate, Menthol And Capsaicin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN",
"StrengthNumber": "18; 6; .015",
"StrengthUnit": "g/60mL; g/60mL; g/60mL",
"Status": "Active",
"LastUpdate": "2024-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease."
},
{
"NDCCode": "63187-175-04",
"PackageDescription": "4 BLISTER PACK in 1 BOX (63187-175-04) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "63187-0175-04",
"ProductNDC": "63187-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20080206",
"SamplePackage": "N"
},
{
"NDCCode": "63187-189-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04) ",
"NDC11Code": "63187-0189-04",
"ProductNDC": "63187-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065223",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220914",
"SamplePackage": "N",
"IndicationAndUsage": "Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: 1 patients with cystic fibrosis,, 2 patients with nosocomially acquired infections,, 3 patients with known or suspected bacteremia,, 4 patients requiring hospitalization,, 5 elderly or debilitated patients, or, 6 patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide. The 500 mg tablets also contain FD&C blue #2."
},
{
"NDCCode": "63187-256-04",
"PackageDescription": "4 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-04) ",
"NDC11Code": "63187-0256-04",
"ProductNDC": "63187-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20070627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078152",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240919",
"SamplePackage": "N",
"IndicationAndUsage": "Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets USP and ondansetron orally disintegrating tablets USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. .",
"Description": "The active ingredient in ondansetron tablets USP is ondansetron hydrochloride (HCl) USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.85. Ondansetron HCl USP dihydrate is a white to off-white powder that is sparingly soluble in water and in alcohol; soluble in methanol, slightly soluble in isopropyl alcohol, and in dichloromethane; very slightly soluble in acetone, in chloroform and in ethyl acetate. The active ingredient in ondansetron orally disintegrating tablets USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:. The empirical formula is C18H19N3O representing a molecular weight of 293.4. Each 4-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron. Each 24-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose, iron oxide yellow (8 mg tablet only), iron oxide red (24 mg tablet only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Each 4-mg ondansetron orally disintegrating tablet USP for oral administration contains 4 mg ondansetron base. Each 8-mg ondansetron orally disintegrating tablet USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sodium stearyl fumarate and strawberry flavor. Ondansetron orally disintegrating tablets USP are an orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product disintegrates in approximately 60 seconds."
},
{
"NDCCode": "63187-271-04",
"PackageDescription": "4 mL in 1 BOTTLE (63187-271-04) ",
"NDC11Code": "63187-0271-04",
"ProductNDC": "63187-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine With Codeine",
"NonProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040650",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold."
},
{
"NDCCode": "63187-272-04",
"PackageDescription": "118 mL in 1 BOTTLE (63187-272-04) ",
"NDC11Code": "63187-0272-04",
"ProductNDC": "63187-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide And Promethazine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040649",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula."
},
{
"NDCCode": "63187-291-04",
"PackageDescription": "118 mL in 1 BOTTLE (63187-291-04) ",
"NDC11Code": "63187-0291-04",
"ProductNDC": "63187-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19810821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087508",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.",
"Description": "Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 5 mL, for oral administration, contains. INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose."
},
{
"NDCCode": "63187-294-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-294-04) ",
"NDC11Code": "63187-0294-04",
"ProductNDC": "63187-294",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Silapap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19940905",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181201",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Uses To reduce fever and for the temporary relief of minor aches and pains due to: : 1 Headache, 2 Muscular aches, 3 Backache, 4 Minor pain of arthritis, 5 The common cold, 6 Toothache, 7 Premenstrual and menstrual cramps."
},
{
"NDCCode": "63187-315-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (63187-315-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "63187-0315-04",
"ProductNDC": "63187-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banophen",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20061120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150202",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itching of the nose or throat. runny nose. itchy, watery eyes."
},
{
"NDCCode": "63187-338-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-338-04) ",
"NDC11Code": "63187-0338-04",
"ProductNDC": "63187-338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19821115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087953",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sodium propionate. Promethazine HCl is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "63187-355-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-355-04) ",
"NDC11Code": "63187-0355-04",
"ProductNDC": "63187-355",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextromethorphan Hydrobromide And Promethazine Hydrochloride",
"NonProprietaryName": "Dextromethorphan Hydrobromide And Promethazine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19850104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088864",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160901",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl, and the following structural formula."
},
{
"NDCCode": "63187-436-04",
"PackageDescription": "120 mL in 1 BOTTLE, GLASS (63187-436-04) ",
"NDC11Code": "63187-0436-04",
"ProductNDC": "63187-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20131203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078488",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.",
"Description": "Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [(4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride syrup is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the syrup are: banana flavor; glacial acetic acid; glycerin; grape flavor; methylparaben; propylene glycol; propylparaben; sodium acetate; sucrose; and water."
},
{
"NDCCode": "63187-494-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-494-04) ",
"NDC11Code": "63187-0494-04",
"ProductNDC": "63187-494",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19950309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087294",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150202",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows. Inactive Ingredients for Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) are: alcohol 0.5%; liquid sugar; methylparaben; peppermint oil; propylene glycol; propylparaben; purified water and spearmint oil. It may also contain citric acid anhydrous or sodium citrate dihydrate for pH adjustment. The pH range is between 2.0 and 4.3."
},
{
"NDCCode": "63187-526-04",
"PackageDescription": "4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-04) ",
"NDC11Code": "63187-0526-04",
"ProductNDC": "63187-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20100412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090469",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191125",
"SamplePackage": "N",
"IndicationAndUsage": "Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder.Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds."
},
{
"NDCCode": "63187-538-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04) ",
"NDC11Code": "63187-0538-04",
"ProductNDC": "63187-538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "Proficient Rx LP",
"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": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150901",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "63187-557-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (63187-557-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "63187-0557-04",
"ProductNDC": "63187-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Lice Killing",
"NonProprietaryName": "Piperonyl Butoxide, Pyrethrum Extract",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071208",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M031",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT",
"StrengthNumber": "4; .33",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "treats head, pubic (crab), and body lice."
},
{
"NDCCode": "63187-580-04",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (63187-580-04) > 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "63187-0580-04",
"ProductNDC": "63187-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076984",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N"
},
{
"NDCCode": "63187-584-04",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (63187-584-04) ",
"NDC11Code": "63187-0584-04",
"ProductNDC": "63187-584",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets USP were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets USP to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "63187-588-04",
"PackageDescription": "118 mL in 1 BOTTLE (63187-588-04) ",
"NDC11Code": "63187-0588-04",
"ProductNDC": "63187-588",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Mapap Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120820",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache."
},
{
"NDCCode": "63187-595-04",
"PackageDescription": "118 mL in 1 BOTTLE (63187-595-04) ",
"NDC11Code": "63187-0595-04",
"ProductNDC": "63187-595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20100317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090180",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE",
"StrengthNumber": "6.25; 10",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N"
},
{
"NDCCode": "63187-664-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (63187-664-04) ",
"NDC11Code": "63187-0664-04",
"ProductNDC": "63187-664",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205292",
"LabelerName": "Proficient Rx LP",
"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": "2021-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "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, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP ................. 2 mg. Pseudoephedrine Hydrochloride, USP ........ 30 mg. Dextromethorphan Hydrobromide, USP ...... 10 mg. Alcohol 0.95% v/v. In a palatable, aromatic vehicle. Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No. 40. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration."
},
{
"NDCCode": "63187-688-04",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (63187-688-04) ",
"NDC11Code": "63187-0688-04",
"ProductNDC": "63187-688",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pedia Relief",
"NonProprietaryName": "Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970105",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "1; 15; 5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N"
},
{
"NDCCode": "63187-738-04",
"PackageDescription": "4 CAPSULE in 1 BOTTLE, PLASTIC (63187-738-04) ",
"NDC11Code": "63187-0738-04",
"ProductNDC": "63187-738",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19910731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063083",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be re‑served for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of co‑li‑tis, as described in the WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 150 mg capsule shell also contains black iron oxide and yellow iron oxide. The structural formula is represented below. C18H33CIN2O5SHCl M.W. 461.44. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "63187-776-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (63187-776-04) ",
"NDC11Code": "63187-0776-04",
"ProductNDC": "63187-776",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "Proficient Rx LP",
"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": "2022-04-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1): 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .",
"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 valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "63187-827-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04) ",
"NDC11Code": "63187-0827-04",
"ProductNDC": "63187-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203458",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
}
]
}
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<NDC>
<NDCCode>63187-400-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-400-04) </PackageDescription>
<NDC11Code>63187-0400-04</NDC11Code>
<ProductNDC>63187-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphanhydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088811</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 10; 30</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>Deprecated</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>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 Oral Syrup is a clear, light pink syrup with a butterscotch flavor. Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>63187-007-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (63187-007-04) </PackageDescription>
<NDC11Code>63187-0007-04</NDC11Code>
<ProductNDC>63187-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065225</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: 1 patients with cystic fibrosis,, 2 patients with nosocomially acquired infections,, 3 patients with known or suspected bacteremia,, 4 patients requiring hospitalization,, 5 elderly or debilitated patients, or, 6 patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide. The 500 mg tablets also contain FD&C blue #2.</Description>
</NDC>
<NDC>
<NDCCode>63187-035-04</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE (63187-035-04) </PackageDescription>
<NDC11Code>63187-0035-04</NDC11Code>
<ProductNDC>63187-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070033</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole Tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).</IndicationAndUsage>
<Description>Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1H-Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula. C6H9N3O3 M.W. 171.15. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
</NDC>
<NDC>
<NDCCode>63187-040-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-040-04) </PackageDescription>
<NDC11Code>63187-0040-04</NDC11Code>
<ProductNDC>63187-040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Q Tussin Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr And Guaifenesin</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-117-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63187-117-04) </PackageDescription>
<NDC11Code>63187-0117-04</NDC11Code>
<ProductNDC>63187-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Guaifenesin And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
<Description>Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg. Inactive Ingredients: Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol. Sodium Content: 5 mg/5 mL. Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ.</Description>
</NDC>
<NDC>
<NDCCode>63187-136-04</NDCCode>
<PackageDescription>50 BOTTLE in 1 CARTON (63187-136-04) / 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63187-0136-04</NDC11Code>
<ProductNDC>63187-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dendracin Neurodendraxcin</ProprietaryName>
<NonProprietaryName>Methyl Salicylate, Menthol And Capsaicin</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN</SubstanceName>
<StrengthNumber>18; 6; .015</StrengthNumber>
<StrengthUnit>g/60mL; g/60mL; g/60mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-175-04</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 BOX (63187-175-04) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63187-0175-04</NDC11Code>
<ProductNDC>63187-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-189-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04) </PackageDescription>
<NDC11Code>63187-0189-04</NDC11Code>
<ProductNDC>63187-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065223</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: 1 patients with cystic fibrosis,, 2 patients with nosocomially acquired infections,, 3 patients with known or suspected bacteremia,, 4 patients requiring hospitalization,, 5 elderly or debilitated patients, or, 6 patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide. The 500 mg tablets also contain FD&C blue #2.</Description>
</NDC>
<NDC>
<NDCCode>63187-256-04</NDCCode>
<PackageDescription>4 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-04) </PackageDescription>
<NDC11Code>63187-0256-04</NDC11Code>
<ProductNDC>63187-256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078152</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets USP and ondansetron orally disintegrating tablets USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets USP is ondansetron hydrochloride (HCl) USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.85. Ondansetron HCl USP dihydrate is a white to off-white powder that is sparingly soluble in water and in alcohol; soluble in methanol, slightly soluble in isopropyl alcohol, and in dichloromethane; very slightly soluble in acetone, in chloroform and in ethyl acetate. The active ingredient in ondansetron orally disintegrating tablets USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:. The empirical formula is C18H19N3O representing a molecular weight of 293.4. Each 4-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron. Each 24-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose, iron oxide yellow (8 mg tablet only), iron oxide red (24 mg tablet only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Each 4-mg ondansetron orally disintegrating tablet USP for oral administration contains 4 mg ondansetron base. Each 8-mg ondansetron orally disintegrating tablet USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sodium stearyl fumarate and strawberry flavor. Ondansetron orally disintegrating tablets USP are an orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product disintegrates in approximately 60 seconds.</Description>
</NDC>
<NDC>
<NDCCode>63187-271-04</NDCCode>
<PackageDescription>4 mL in 1 BOTTLE (63187-271-04) </PackageDescription>
<NDC11Code>63187-0271-04</NDC11Code>
<ProductNDC>63187-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine With Codeine</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040650</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-272-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63187-272-04) </PackageDescription>
<NDC11Code>63187-0272-04</NDC11Code>
<ProductNDC>63187-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide And Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040649</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCI, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63187-291-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63187-291-04) </PackageDescription>
<NDC11Code>63187-0291-04</NDC11Code>
<ProductNDC>63187-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087508</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 5 mL, for oral administration, contains. INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>63187-294-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-294-04) </PackageDescription>
<NDC11Code>63187-0294-04</NDC11Code>
<ProductNDC>63187-294</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Silapap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940905</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses To reduce fever and for the temporary relief of minor aches and pains due to: : 1 Headache, 2 Muscular aches, 3 Backache, 4 Minor pain of arthritis, 5 The common cold, 6 Toothache, 7 Premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-315-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63187-315-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63187-0315-04</NDC11Code>
<ProductNDC>63187-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banophen</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing. itching of the nose or throat. runny nose. itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-338-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-338-04) </PackageDescription>
<NDC11Code>63187-0338-04</NDC11Code>
<ProductNDC>63187-338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087953</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sodium propionate. Promethazine HCl is a racemic compound; the molecular formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>63187-355-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-355-04) </PackageDescription>
<NDC11Code>63187-0355-04</NDC11Code>
<ProductNDC>63187-355</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextromethorphan Hydrobromide And Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide And Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19850104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088864</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63187-436-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, GLASS (63187-436-04) </PackageDescription>
<NDC11Code>63187-0436-04</NDC11Code>
<ProductNDC>63187-436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078488</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.</IndicationAndUsage>
<Description>Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [(4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride syrup is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the syrup are: banana flavor; glacial acetic acid; glycerin; grape flavor; methylparaben; propylene glycol; propylparaben; sodium acetate; sucrose; and water.</Description>
</NDC>
<NDC>
<NDCCode>63187-494-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-494-04) </PackageDescription>
<NDC11Code>63187-0494-04</NDC11Code>
<ProductNDC>63187-494</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087294</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows. Inactive Ingredients for Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) are: alcohol 0.5%; liquid sugar; methylparaben; peppermint oil; propylene glycol; propylparaben; purified water and spearmint oil. It may also contain citric acid anhydrous or sodium citrate dihydrate for pH adjustment. The pH range is between 2.0 and 4.3.</Description>
</NDC>
<NDC>
<NDCCode>63187-526-04</NDCCode>
<PackageDescription>4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-04) </PackageDescription>
<NDC11Code>63187-0526-04</NDC11Code>
<ProductNDC>63187-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090469</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder.Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds.</Description>
</NDC>
<NDC>
<NDCCode>63187-538-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04) </PackageDescription>
<NDC11Code>63187-0538-04</NDC11Code>
<ProductNDC>63187-538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>Proficient Rx LP</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>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride,USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>63187-557-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63187-557-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63187-0557-04</NDC11Code>
<ProductNDC>63187-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Lice Killing</ProprietaryName>
<NonProprietaryName>Piperonyl Butoxide, Pyrethrum Extract</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M031</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT</SubstanceName>
<StrengthNumber>4; .33</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats head, pubic (crab), and body lice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-580-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (63187-580-04) > 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63187-0580-04</NDC11Code>
<ProductNDC>63187-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076984</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-584-04</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (63187-584-04) </PackageDescription>
<NDC11Code>63187-0584-04</NDC11Code>
<ProductNDC>63187-584</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets USP were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets USP to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>63187-588-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63187-588-04) </PackageDescription>
<NDC11Code>63187-0588-04</NDC11Code>
<ProductNDC>63187-588</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Mapap Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-595-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (63187-595-04) </PackageDescription>
<NDC11Code>63187-0595-04</NDC11Code>
<ProductNDC>63187-595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090180</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>6.25; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-664-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (63187-664-04) </PackageDescription>
<NDC11Code>63187-0664-04</NDC11Code>
<ProductNDC>63187-664</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205292</ApplicationNumber>
<LabelerName>Proficient Rx LP</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>2021-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>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, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP ................. 2 mg. Pseudoephedrine Hydrochloride, USP ........ 30 mg. Dextromethorphan Hydrobromide, USP ...... 10 mg. Alcohol 0.95% v/v. In a palatable, aromatic vehicle. Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No. 40. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>63187-688-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (63187-688-04) </PackageDescription>
<NDC11Code>63187-0688-04</NDC11Code>
<ProductNDC>63187-688</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pedia Relief</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>1; 15; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-738-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BOTTLE, PLASTIC (63187-738-04) </PackageDescription>
<NDC11Code>63187-0738-04</NDC11Code>
<ProductNDC>63187-738</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063083</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be re‑served for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of co‑li‑tis, as described in the WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The 150 mg capsule shell also contains black iron oxide and yellow iron oxide. The structural formula is represented below. C18H33CIN2O5SHCl M.W. 461.44. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>63187-776-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (63187-776-04) </PackageDescription>
<NDC11Code>63187-0776-04</NDC11Code>
<ProductNDC>63187-776</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>Proficient Rx LP</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>2022-04-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1): 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission , 3 Herpes Zoster .</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 valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>63187-827-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-04) </PackageDescription>
<NDC11Code>63187-0827-04</NDC11Code>
<ProductNDC>63187-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203458</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
</NDC>
</NDCList>