{
"NDC": [
{
"NDCCode": "11819-359-10",
"PackageDescription": "10 TABLET, COATED in 1 BOTTLE (11819-359-10)",
"NDC11Code": "11819-0359-10",
"ProductNDC": "11819-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combivir",
"NonProprietaryName": "Lamivudine And Zidovudine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970930",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020857",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "150; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "11819-359-14",
"PackageDescription": "14 TABLET, COATED in 1 BOTTLE (11819-359-14)",
"NDC11Code": "11819-0359-14",
"ProductNDC": "11819-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combivir",
"NonProprietaryName": "Lamivudine And Zidovudine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970930",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020857",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "150; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "11819-282-08",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-282-08)",
"NDC11Code": "11819-0282-08",
"ProductNDC": "11819-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Probenecid",
"NonProprietaryName": "Probenecid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19830701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084442",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "PROBENECID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.",
"Description": "Probenecid is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid Tablets USP 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "11819-305-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (11819-305-30)",
"NDC11Code": "11819-0305-30",
"ProductNDC": "11819-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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": "Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of this light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid and titanium dioxide."
},
{
"NDCCode": "11819-311-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (11819-311-30)",
"NDC11Code": "11819-0311-30",
"ProductNDC": "11819-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide."
},
{
"NDCCode": "11819-342-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-342-20)",
"NDC11Code": "11819-0342-20",
"ProductNDC": "11819-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kaletra",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021906",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The following points should be considered when initiating therapy with KALETRA: 1 The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)]., 2 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Clinical Pharmacology (12.4)]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Clinical Pharmacology (12.4)]., 3 Once daily administration of KALETRA is not recommended for any pediatric patients.",
"Description": "KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. KALETRA film-coated tablets are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow tablets containing 100 mg of lopinavir and 25 mg of ritonavir."
},
{
"NDCCode": "11819-348-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-348-20)",
"NDC11Code": "11819-0348-20",
"ProductNDC": "11819-348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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": "Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of this light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid and titanium dioxide."
},
{
"NDCCode": "10893-359-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (10893-359-10) > 1 LIQUID in 1 BOTTLE, GLASS",
"NDC11Code": "10893-0359-10",
"ProductNDC": "10893-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil",
"ProprietaryNameSuffix": "Acne",
"NonProprietaryName": "Phosphoric Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "PHOSPHORIC ACID",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-01-22",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "21130-359-10",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (21130-359-10) ",
"NDC11Code": "21130-0359-10",
"ProductNDC": "21130-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202312",
"LabelerName": "BETTER LIVING BRANDS LLC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to. ■ headache. ■ muscular aches. ■ minor pain of arthritis. ■ toothache. ■ backache. ■ the common cold. ■ menstrual cramps. ■ temporarily reduces fever."
},
{
"NDCCode": "21749-359-10",
"PackageDescription": "10 PACKAGE in 1 PACKAGE (21749-359-10) / 37 mL in 1 PACKAGE",
"NDC11Code": "21749-0359-10",
"ProductNDC": "21749-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Hand Sanitizing Wipes Clean Refreshing Scent",
"NonProprietaryName": "Benzalkonium Chloride Wipe",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140801",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "24236-359-08",
"PackageDescription": "10 TABLET in 1 VIAL (24236-359-08)",
"NDC11Code": "24236-0359-08",
"ProductNDC": "24236-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040355",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2016-03-18"
},
{
"NDCCode": "31722-359-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (31722-359-10)",
"NDC11Code": "31722-0359-10",
"ProductNDC": "31722-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202942",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets USP, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride tablet USP is available as an oral tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, sugar spheres and magnesium stearate."
},
{
"NDCCode": "42254-359-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42254-359-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "42254-0359-10",
"ProductNDC": "42254-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Decongestant",
"NonProprietaryName": "Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19990812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075153",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "43063-359-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (43063-359-10)",
"NDC11Code": "43063-0359-10",
"ProductNDC": "43063-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-08-29"
},
{
"NDCCode": "43547-359-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (43547-359-10) ",
"NDC11Code": "43547-0359-10",
"ProductNDC": "43547-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"EndMarketingDate": "20201003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "Solco Healthcare U.S., LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141015",
"EndMarketingDatePackage": "20201003",
"SamplePackage": "N"
},
{
"NDCCode": "49643-359-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-359-10) ",
"NDC11Code": "49643-0359-10",
"ProductNDC": "49643-359",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Arizona Ash Pollen",
"NonProprietaryName": "Fraxinus Velutina",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "FRAXINUS VELUTINA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "51991-359-11",
"PackageDescription": "10 BLISTER PACK in 1 BOX (51991-359-11) / 10 TABLET in 1 BLISTER PACK (51991-359-99) ",
"NDC11Code": "51991-0359-11",
"ProductNDC": "51991-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asenapine",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20210308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205960",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210308",
"SamplePackage": "N",
"IndicationAndUsage": "Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.",
"Description": "Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO∙C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture)."
},
{
"NDCCode": "51991-359-60",
"PackageDescription": "6 BLISTER PACK in 1 BOX (51991-359-60) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "51991-0359-60",
"ProductNDC": "51991-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asenapine",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20210308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205960",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210308",
"SamplePackage": "N",
"IndicationAndUsage": "Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.",
"Description": "Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO∙C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture)."
},
{
"NDCCode": "52817-359-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 PACKAGE (52817-359-10) ",
"NDC11Code": "52817-0359-10",
"ProductNDC": "52817-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "TruPharma LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "Y",
"IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).",
"Description": "Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake."
},
{
"NDCCode": "54575-359-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-359-10)",
"NDC11Code": "54575-0359-10",
"ProductNDC": "54575-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabbage",
"NonProprietaryName": "Cabbage",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "CABBAGE",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "58411-359-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58411-359-10) > 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "58411-0359-10",
"ProductNDC": "58411-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "1288; 2524; 2575; 1545",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "59262-359-13",
"PackageDescription": "1 BOTTLE, DROPPER in 1 PACKET (59262-359-13) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "59262-0359-13",
"ProductNDC": "59262-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Complete Eye Relief Single Use",
"NonProprietaryName": "Atropa Belladonna, Euphrasia Stricta And Mercuric Chloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Similasan Corporation",
"SubstanceName": "ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "59746-359-10",
"PackageDescription": "1000 TABLET, CHEWABLE in 1 BOTTLE (59746-359-10) ",
"NDC11Code": "59746-0359-10",
"ProductNDC": "59746-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium Chewable",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203795",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150228",
"SamplePackage": "N"
},
{
"NDCCode": "59746-359-12",
"PackageDescription": "10 TABLET, CHEWABLE in 1 BLISTER PACK (59746-359-12) ",
"NDC11Code": "59746-0359-12",
"ProductNDC": "59746-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium Chewable",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203795",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150228",
"SamplePackage": "N"
},
{
"NDCCode": "61919-359-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (61919-359-10)",
"NDC11Code": "61919-0359-10",
"ProductNDC": "61919-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levaquin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "DIRECT RX",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP 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. Levofloxacin tablets, USP are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin tablets, USP [see Microbiology(12.4)]. Therapy with levofloxacin tablets, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets, USP. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. 1.1 Nosocomial Pneumonia. Levofloxacin tablets, USP are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1)and Clinical Studies (14.3)]. 1.4 Acute Bacterial Sinusitis: 5-day and 10-14 day Treatment Regimens. Levofloxacin tablets, USP are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. 1.5 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets, USP are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 1.6 Complicated Skin and Skin Structure Infections. Levofloxacin tablets, USP are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.7 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets, USP are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.8 Chronic Bacterial Prostatitis. Levofloxacin tablets, USP are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies(14.7, 14.8)].]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets, USP are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. 1.13 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets, USP are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets, USP are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets, USP has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets, USP in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablets, USP therapy should only be used when the benefit outweighs the risk [see Dosage and Administration(2.1, 2.2) and Clinical Studies (14.9)]. 1.14 Plague. Levofloxacin tablets, USP are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin tablets, USP could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [seeDosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].",
"Description": "Levofloxacin USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin USP. Structure. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets, USP. Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients. 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide. 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides. 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "63323-359-03",
"PackageDescription": "10 VIAL in 1 TRAY (63323-359-03) > 3 mL in 1 VIAL",
"NDC11Code": "63323-0359-03",
"ProductNDC": "63323-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kanamycin",
"NonProprietaryName": "Kanamycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20030128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065111",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "KANAMYCIN A SULFATE",
"StrengthNumber": "333",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68084-359-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68084-359-01) > 10 TABLET in 1 BLISTER PACK (68084-359-11)",
"NDC11Code": "68084-0359-01",
"ProductNDC": "68084-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071135",
"LabelerName": "American Health Packaging",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "69367-359-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (69367-359-10) ",
"NDC11Code": "69367-0359-10",
"ProductNDC": "69367-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207062",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets is indicated: 1 To reduce the risk major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce LDL-C and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white or almost white, hygroscopic powder that is slightly soluble in water, freely soluble in methylene chloride, practically insoluble in ethanol. Rosuvastatin calcium has a partition coefficient (octanol/water) of 2.20 at pH of 7.3. Rosuvastatin for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&C yellow #10 aluminium lake, FD&C red #40/allura red AC aluminium lake, FD&C blue #2/ indigo carmine aluminium lake, FD&C yellow #6/ sunset yellow FCF aluminium lake."
},
{
"NDCCode": "69842-359-10",
"PackageDescription": "10 LOZENGE in 1 BAG (69842-359-10) ",
"NDC11Code": "69842-0359-10",
"ProductNDC": "69842-359",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Clean Label Throat Relief Pops",
"NonProprietaryName": "Pectin",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190411",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "PECTIN",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190411",
"SamplePackage": "N"
},
{
"NDCCode": "71205-359-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (71205-359-10) ",
"NDC11Code": "71205-0359-10",
"ProductNDC": "71205-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208348",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>11819-359-10</NDCCode>
<PackageDescription>10 TABLET, COATED in 1 BOTTLE (11819-359-10)</PackageDescription>
<NDC11Code>11819-0359-10</NDC11Code>
<ProductNDC>11819-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combivir</ProprietaryName>
<NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970930</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020857</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>11819-359-14</NDCCode>
<PackageDescription>14 TABLET, COATED in 1 BOTTLE (11819-359-14)</PackageDescription>
<NDC11Code>11819-0359-14</NDC11Code>
<ProductNDC>11819-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combivir</ProprietaryName>
<NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970930</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020857</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>11819-282-08</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-282-08)</PackageDescription>
<NDC11Code>11819-0282-08</NDC11Code>
<ProductNDC>11819-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Probenecid</ProprietaryName>
<NonProprietaryName>Probenecid</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084442</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>PROBENECID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.</IndicationAndUsage>
<Description>Probenecid is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula. C13H19NO4S M.W. 285.36. Probenecid is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Probenecid Tablets USP 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11819-305-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (11819-305-30)</PackageDescription>
<NDC11Code>11819-0305-30</NDC11Code>
<ProductNDC>11819-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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>Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of this light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11819-311-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (11819-311-30)</PackageDescription>
<NDC11Code>11819-0311-30</NDC11Code>
<ProductNDC>11819-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline Hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. The structural formula is as follows. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11819-342-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-342-20)</PackageDescription>
<NDC11Code>11819-0342-20</NDC11Code>
<ProductNDC>11819-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kaletra</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100618</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021906</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The following points should be considered when initiating therapy with KALETRA: 1 The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)]., 2 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Clinical Pharmacology (12.4)]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Clinical Pharmacology (12.4)]., 3 Once daily administration of KALETRA is not recommended for any pediatric patients.</IndicationAndUsage>
<Description>KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. KALETRA film-coated tablets are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
</NDC>
<NDC>
<NDCCode>11819-348-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-348-20)</PackageDescription>
<NDC11Code>11819-0348-20</NDC11Code>
<ProductNDC>11819-348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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>Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of this light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10893-359-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10893-359-10) > 1 LIQUID in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>10893-0359-10</NDC11Code>
<ProductNDC>10893-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil</ProprietaryName>
<ProprietaryNameSuffix>Acne</ProprietaryNameSuffix>
<NonProprietaryName>Phosphoric Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-22</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21130-359-10</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (21130-359-10) </PackageDescription>
<NDC11Code>21130-0359-10</NDC11Code>
<ProductNDC>21130-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202312</ApplicationNumber>
<LabelerName>BETTER LIVING BRANDS LLC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to. ■ headache. ■ muscular aches. ■ minor pain of arthritis. ■ toothache. ■ backache. ■ the common cold. ■ menstrual cramps. ■ temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21749-359-10</NDCCode>
<PackageDescription>10 PACKAGE in 1 PACKAGE (21749-359-10) / 37 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>21749-0359-10</NDC11Code>
<ProductNDC>21749-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Hand Sanitizing Wipes Clean Refreshing Scent</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride Wipe</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24236-359-08</NDCCode>
<PackageDescription>10 TABLET in 1 VIAL (24236-359-08)</PackageDescription>
<NDC11Code>24236-0359-08</NDC11Code>
<ProductNDC>24236-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040355</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-03-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-359-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (31722-359-10)</PackageDescription>
<NDC11Code>31722-0359-10</NDC11Code>
<ProductNDC>31722-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202942</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets USP, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride tablet USP is available as an oral tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, sugar spheres and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>42254-359-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42254-359-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42254-0359-10</NDC11Code>
<ProductNDC>42254-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075153</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-359-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-359-10)</PackageDescription>
<NDC11Code>43063-0359-10</NDC11Code>
<ProductNDC>43063-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>500; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>43547-359-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (43547-359-10) </PackageDescription>
<NDC11Code>43547-0359-10</NDC11Code>
<ProductNDC>43547-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<EndMarketingDate>20201003</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>Solco Healthcare U.S., LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141015</StartMarketingDatePackage>
<EndMarketingDatePackage>20201003</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49643-359-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-359-10) </PackageDescription>
<NDC11Code>49643-0359-10</NDC11Code>
<ProductNDC>49643-359</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Arizona Ash Pollen</ProprietaryName>
<NonProprietaryName>Fraxinus Velutina</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>FRAXINUS VELUTINA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>51991-359-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (51991-359-11) / 10 TABLET in 1 BLISTER PACK (51991-359-99) </PackageDescription>
<NDC11Code>51991-0359-11</NDC11Code>
<ProductNDC>51991-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asenapine</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20210308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205960</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.</IndicationAndUsage>
<Description>Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO∙C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture).</Description>
</NDC>
<NDC>
<NDCCode>51991-359-60</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX (51991-359-60) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51991-0359-60</NDC11Code>
<ProductNDC>51991-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asenapine</ProprietaryName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20210308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205960</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Asenapine sublingual tablets are indicated for: 1 Schizophrenia in adults [see Clinical Studies (14.1)], 2 Bipolar I disorder [see Clinical Studies (14.2)]Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of ageAdjunctive treatment to lithium or valproate in adultsMaintenance monotherapy treatment in adults.</IndicationAndUsage>
<Description>Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO∙C4H4O4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is. Asenapine maleate is a white to off-white powder. Asenapine sublingual tablets (Unflavored) are supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone. Asenapine sublingual tablets, black cherry flavor, are supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include aspartame, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate and povidone and black cherry flavor (components are nature identical flavorings, natural flavoring substances, natural flavoring complexes, maize maltodextrin and moisture).</Description>
</NDC>
<NDC>
<NDCCode>52817-359-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 PACKAGE (52817-359-10) </PackageDescription>
<NDC11Code>52817-0359-10</NDC11Code>
<ProductNDC>52817-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).</IndicationAndUsage>
<Description>Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake.</Description>
</NDC>
<NDC>
<NDCCode>54575-359-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-359-10)</PackageDescription>
<NDC11Code>54575-0359-10</NDC11Code>
<ProductNDC>54575-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabbage</ProprietaryName>
<NonProprietaryName>Cabbage</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>CABBAGE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>58411-359-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58411-359-10) > 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58411-0359-10</NDC11Code>
<ProductNDC>58411-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>1288; 2524; 2575; 1545</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59262-359-13</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 PACKET (59262-359-13) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>59262-0359-13</NDC11Code>
<ProductNDC>59262-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Complete Eye Relief Single Use</ProprietaryName>
<NonProprietaryName>Atropa Belladonna, Euphrasia Stricta And Mercuric Chloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Similasan Corporation</LabelerName>
<SubstanceName>ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59746-359-10</NDCCode>
<PackageDescription>1000 TABLET, CHEWABLE in 1 BOTTLE (59746-359-10) </PackageDescription>
<NDC11Code>59746-0359-10</NDC11Code>
<ProductNDC>59746-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium Chewable</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203795</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59746-359-12</NDCCode>
<PackageDescription>10 TABLET, CHEWABLE in 1 BLISTER PACK (59746-359-12) </PackageDescription>
<NDC11Code>59746-0359-12</NDC11Code>
<ProductNDC>59746-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium Chewable</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203795</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-359-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (61919-359-10)</PackageDescription>
<NDC11Code>61919-0359-10</NDC11Code>
<ProductNDC>61919-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levaquin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200839</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP 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. Levofloxacin tablets, USP are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin tablets, USP [see Microbiology(12.4)]. Therapy with levofloxacin tablets, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets, USP. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. 1.1 Nosocomial Pneumonia. Levofloxacin tablets, USP are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1)and Clinical Studies (14.3)]. 1.4 Acute Bacterial Sinusitis: 5-day and 10-14 day Treatment Regimens. Levofloxacin tablets, USP are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. 1.5 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets, USP are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 1.6 Complicated Skin and Skin Structure Infections. Levofloxacin tablets, USP are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.7 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets, USP are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.8 Chronic Bacterial Prostatitis. Levofloxacin tablets, USP are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin tablets, USP are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies(14.7, 14.8)].]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets, USP are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. 1.13 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets, USP are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets, USP are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets, USP has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets, USP in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablets, USP therapy should only be used when the benefit outweighs the risk [see Dosage and Administration(2.1, 2.2) and Clinical Studies (14.9)]. 1.14 Plague. Levofloxacin tablets, USP are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin tablets, USP could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [seeDosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].</IndicationAndUsage>
<Description>Levofloxacin USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (--(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin USP. Structure. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets, USP. Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients. 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide. 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides. 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>63323-359-03</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-359-03) > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0359-03</NDC11Code>
<ProductNDC>63323-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kanamycin</ProprietaryName>
<NonProprietaryName>Kanamycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20030128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065111</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>KANAMYCIN A SULFATE</SubstanceName>
<StrengthNumber>333</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68084-359-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68084-359-01) > 10 TABLET in 1 BLISTER PACK (68084-359-11)</PackageDescription>
<NDC11Code>68084-0359-01</NDC11Code>
<ProductNDC>68084-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071135</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>69367-359-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69367-359-10) </PackageDescription>
<NDC11Code>69367-0359-10</NDC11Code>
<ProductNDC>69367-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207062</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets is indicated: 1 To reduce the risk major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce LDL-C and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white or almost white, hygroscopic powder that is slightly soluble in water, freely soluble in methylene chloride, practically insoluble in ethanol. Rosuvastatin calcium has a partition coefficient (octanol/water) of 2.20 at pH of 7.3. Rosuvastatin for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&C yellow #10 aluminium lake, FD&C red #40/allura red AC aluminium lake, FD&C blue #2/ indigo carmine aluminium lake, FD&C yellow #6/ sunset yellow FCF aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>69842-359-10</NDCCode>
<PackageDescription>10 LOZENGE in 1 BAG (69842-359-10) </PackageDescription>
<NDC11Code>69842-0359-10</NDC11Code>
<ProductNDC>69842-359</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Clean Label Throat Relief Pops</ProprietaryName>
<NonProprietaryName>Pectin</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>PECTIN</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-359-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (71205-359-10) </PackageDescription>
<NDC11Code>71205-0359-10</NDC11Code>
<ProductNDC>71205-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208348</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate.</Description>
</NDC>
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