{
"NDC": [
{
"NDCCode": "54575-089-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (54575-089-30)",
"NDC11Code": "54575-0089-30",
"ProductNDC": "54575-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Canary Grass Pollen",
"NonProprietaryName": "Phalaris Minor Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PHALARIS MINOR POLLEN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "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": "54575-089-02",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-089-02)",
"NDC11Code": "54575-0089-02",
"ProductNDC": "54575-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Canary Grass Pollen",
"NonProprietaryName": "Phalaris Minor Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PHALARIS MINOR POLLEN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "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": "54575-089-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-089-10)",
"NDC11Code": "54575-0089-10",
"ProductNDC": "54575-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Canary Grass Pollen",
"NonProprietaryName": "Phalaris Minor Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PHALARIS MINOR POLLEN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "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": "54575-089-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (54575-089-50)",
"NDC11Code": "54575-0089-50",
"ProductNDC": "54575-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Canary Grass Pollen",
"NonProprietaryName": "Phalaris Minor Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PHALARIS MINOR POLLEN",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "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": "11084-089-39",
"PackageDescription": "30 mL in 1 TUBE (11084-089-39)",
"NDC11Code": "11084-0089-39",
"ProductNDC": "11084-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sbs Care",
"NonProprietaryName": "Allantoin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "12714-089-30",
"PackageDescription": "30 mg in 1 TANK (12714-089-30) ",
"NDC11Code": "12714-0089-30",
"ProductNDC": "12714-089",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alemtuzumab",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20010507",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
"SubstanceName": "ALEMTUZUMAB",
"StrengthNumber": "30",
"StrengthUnit": "mg/30mg",
"Status": "Unfinished",
"LastUpdate": "2024-05-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "07-MAY-01"
},
{
"NDCCode": "13107-089-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13107-089-30) ",
"NDC11Code": "13107-0089-30",
"ProductNDC": "13107-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203502",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone Hydrochloride Tablets are indicated forthe: 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 2.Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration and persist over the course of therapy[See Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets is not indicated asanas-needed(prn)analgesic. (1).",
"Description": "Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone Hydrochloride USP is a white powder. Its molecular formula is C21H27 NO HCl and it has a molecular weight of 345.91. Methadone Hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of Methadone Hydrochloride USP. Each tablet contains the following inactive ingredients: Colloidal silicon dioxide, Lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "13668-089-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-30) ",
"NDC11Code": "13668-0089-30",
"ProductNDC": "13668-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091415",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111025",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the. Treatment of schizophrenia. ( 1.1). Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the. Treatment of depressive episodes associated with bipolar I disorder. ( 1.5). Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6). Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP: Meets USP Disintegration Test 2."
},
{
"NDCCode": "16590-089-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (16590-089-30)",
"NDC11Code": "16590-0089-30",
"ProductNDC": "16590-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ery-tab",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062298",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "333",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB 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. ERY-TAB tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet to protect it from the inactivating effects of gastric acidity and to permit efficient absorption of the antibiotic in the small intestine. ERY-TAB tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. ERY-TAB tablets comply with USP Drug Release Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hex-opyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Inactive Ingredients. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide."
},
{
"NDCCode": "16729-089-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-089-10) ",
"NDC11Code": "16729-0089-10",
"ProductNDC": "16729-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091643",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131108",
"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women.",
"Description": "Finasteride tablets, USP contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). The chemical name of finasteride is N-tert-Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water. Finasteride tablets, USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, lauroyl macrogolglycerides, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow."
},
{
"NDCCode": "21922-089-52",
"PackageDescription": "30 PACKET in 1 CARTON (21922-089-52) / 1 g in 1 PACKET",
"NDC11Code": "21922-0089-52",
"ProductNDC": "21922-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Gel",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218507",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).",
"Description": "Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive."
},
{
"NDCCode": "31722-089-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30) ",
"NDC11Code": "31722-0089-30",
"ProductNDC": "31722-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216168",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir amorphous, has the following chemical name: [(1S,2R-3-[[(4-Amino-phenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]-furan-3-yl ester. Its molecular formula is C 27H 37N 3O 7S and its molecular weight is 547.67. Darunavir amorphous has the following structural formula:. Darunavir amorphous is an off-white to pale brown colored powder, freely soluble in chloroform and in dichloromethane. Darunavir 600 mg tablets are available as yellow, oval shaped, biconvex, film-coated tablets debossed with 'V' on one side and '5' on the other side. Each 600 mg tablet contains darunavir amorphous equivalent 600 mg of darunavir. Darunavir 800 mg tablets are available as yellow, oval shaped, biconvex, film-coated tablets debossed with 'V' on one side and '7' on the other side. Each 800 mg tablet contains darunavir amorphous equivalent 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, silicified microcrystalline cellulose. The film coating contains iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. All dosages for darunavir are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "40032-089-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (40032-089-03) ",
"NDC11Code": "40032-0089-03",
"ProductNDC": "40032-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "40032-089-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (40032-089-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK (40032-089-30) ",
"NDC11Code": "40032-0089-31",
"ProductNDC": "40032-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "42254-089-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42254-089-30)",
"NDC11Code": "42254-0089-30",
"ProductNDC": "42254-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "43353-089-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43353-089-30)",
"NDC11Code": "43353-0089-30",
"ProductNDC": "43353-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040301",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Warfarin sodium tablets, USP are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets, USP are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets, USP are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Crystalline warfarin sodium is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt and is a racemic mixture of theR- andS-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its empirical formula is C19H15NaO4, and its structural formula may be represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether. Warfarin Sodium Tablets, USP for oral use also contain."
},
{
"NDCCode": "43386-089-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43386-089-03) ",
"NDC11Code": "43386-0089-03",
"ProductNDC": "43386-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "43386-089-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (43386-089-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-089-30) ",
"NDC11Code": "43386-0089-31",
"ProductNDC": "43386-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207371",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin."
},
{
"NDCCode": "46708-089-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-089-30)",
"NDC11Code": "46708-0089-30",
"ProductNDC": "46708-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202130",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "49349-089-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-089-02)",
"NDC11Code": "49349-0089-02",
"ProductNDC": "49349-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-10"
},
{
"NDCCode": "49999-089-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (49999-089-30)",
"NDC11Code": "49999-0089-30",
"ProductNDC": "49999-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-03"
},
{
"NDCCode": "51060-089-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (51060-089-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "51060-0089-01",
"ProductNDC": "51060-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen",
"ProprietaryNameSuffix": "Light Neutral",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tarte, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "62.3; 38.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "51655-089-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, DISPENSING (51655-089-52)",
"NDC11Code": "51655-0089-52",
"ProductNDC": "51655-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA021210",
"LabelerName": "Northwind Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".025",
"StrengthUnit": "mg/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
"Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous). Inactive Ingredients. Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate, FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "52125-089-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (52125-089-02)",
"NDC11Code": "52125-0089-02",
"ProductNDC": "52125-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077627",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52343-089-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52343-089-30) ",
"NDC11Code": "52343-0089-30",
"ProductNDC": "52343-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110531",
"EndMarketingDate": "20200101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090056",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110531",
"EndMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "52959-089-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (52959-089-30)",
"NDC11Code": "52959-0089-30",
"ProductNDC": "52959-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Levothyroxine sodium is used for the following indications.",
"Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown."
},
{
"NDCCode": "54860-089-01",
"PackageDescription": "30 mL in 1 BOTTLE (54860-089-01) ",
"NDC11Code": "54860-0089-01",
"ProductNDC": "54860-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanilla Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Shenzhen Lantern Science Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180130",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on hands."
},
{
"NDCCode": "60290-089-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (60290-089-01) ",
"NDC11Code": "60290-0089-01",
"ProductNDC": "60290-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220717",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260514",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1)and Clinical Studies (14)] .",
"Description": "Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem N,N,6-trimethyl-2- p-tolylimidazo[ 1,2-a ]pyridine-3-acetamide L(+)-tartrate). It has the following structure:. Zolpidem tartrate is a white to off white powder, hygroscopic, that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular formula of (C 19H 21N 3O) 2· C 4H 6O 6and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac, sodium starch glycolate, strong ammonium solution, titanium dioxide, and the colorants FD&C blue #1, FD&C red #40, FD&C yellow #5."
},
{
"NDCCode": "60637-089-30",
"PackageDescription": "30 mL in 1 BOTTLE (60637-089-30)",
"NDC11Code": "60637-0089-30",
"ProductNDC": "60637-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Justice Bff Go Together Like Unicorns Glitter Berry Scented Anti-bacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Tween Brands, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "620",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "61722-089-00",
"PackageDescription": "1 BOTTLE in 1 BOX (61722-089-00) > 30 mL in 1 BOTTLE",
"NDC11Code": "61722-0089-00",
"ProductNDC": "61722-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flormar Perfect Coverage Foundation Sunscreen Broad Spectrum Spf 15 114 Light Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140721",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kosan Kozmetik Sanayi ve Ticaret A.S.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140721",
"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. ."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54575-089-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (54575-089-30)</PackageDescription>
<NDC11Code>54575-0089-30</NDC11Code>
<ProductNDC>54575-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Canary Grass Pollen</ProprietaryName>
<NonProprietaryName>Phalaris Minor Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS MINOR POLLEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>54575-089-02</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-089-02)</PackageDescription>
<NDC11Code>54575-0089-02</NDC11Code>
<ProductNDC>54575-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Canary Grass Pollen</ProprietaryName>
<NonProprietaryName>Phalaris Minor Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS MINOR POLLEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>54575-089-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-089-10)</PackageDescription>
<NDC11Code>54575-0089-10</NDC11Code>
<ProductNDC>54575-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Canary Grass Pollen</ProprietaryName>
<NonProprietaryName>Phalaris Minor Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS MINOR POLLEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>54575-089-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (54575-089-50)</PackageDescription>
<NDC11Code>54575-0089-50</NDC11Code>
<ProductNDC>54575-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Canary Grass Pollen</ProprietaryName>
<NonProprietaryName>Phalaris Minor Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS MINOR POLLEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>11084-089-39</NDCCode>
<PackageDescription>30 mL in 1 TUBE (11084-089-39)</PackageDescription>
<NDC11Code>11084-0089-39</NDC11Code>
<ProductNDC>11084-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sbs Care</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12714-089-30</NDCCode>
<PackageDescription>30 mg in 1 TANK (12714-089-30) </PackageDescription>
<NDC11Code>12714-0089-30</NDC11Code>
<ProductNDC>12714-089</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alemtuzumab</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20010507</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Pharma GmbH and Co. KG</LabelerName>
<SubstanceName>ALEMTUZUMAB</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/30mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-05-23</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-MAY-01</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13107-089-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13107-089-30) </PackageDescription>
<NDC11Code>13107-0089-30</NDC11Code>
<ProductNDC>13107-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203502</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone Hydrochloride Tablets are indicated forthe: 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 2.Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration and persist over the course of therapy[See Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets is not indicated asanas-needed(prn)analgesic. (1).</IndicationAndUsage>
<Description>Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone Hydrochloride USP is a white powder. Its molecular formula is C21H27 NO HCl and it has a molecular weight of 345.91. Methadone Hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of Methadone Hydrochloride USP. Each tablet contains the following inactive ingredients: Colloidal silicon dioxide, Lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>13668-089-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-30) </PackageDescription>
<NDC11Code>13668-0089-30</NDC11Code>
<ProductNDC>13668-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091415</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the. Treatment of schizophrenia. ( 1.1). Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the. Treatment of depressive episodes associated with bipolar I disorder. ( 1.5). Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6). Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP: Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16590-089-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (16590-089-30)</PackageDescription>
<NDC11Code>16590-0089-30</NDC11Code>
<ProductNDC>16590-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ery-tab</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062298</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>333</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB 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. ERY-TAB tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet to protect it from the inactivating effects of gastric acidity and to permit efficient absorption of the antibiotic in the small intestine. ERY-TAB tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. ERY-TAB tablets comply with USP Drug Release Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hex-opyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is. Inactive Ingredients. Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16729-089-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-089-10) </PackageDescription>
<NDC11Code>16729-0089-10</NDC11Code>
<ProductNDC>16729-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091643</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women.</IndicationAndUsage>
<Description>Finasteride tablets, USP contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). The chemical name of finasteride is N-tert-Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water. Finasteride tablets, USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, lauroyl macrogolglycerides, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>21922-089-52</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (21922-089-52) / 1 g in 1 PACKET</PackageDescription>
<NDC11Code>21922-0089-52</NDC11Code>
<ProductNDC>21922-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Gel</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218507</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).</IndicationAndUsage>
<Description>Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>31722-089-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-089-30) </PackageDescription>
<NDC11Code>31722-0089-30</NDC11Code>
<ProductNDC>31722-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216168</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DARUNAVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir amorphous, has the following chemical name: [(1S,2R-3-[[(4-Amino-phenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]-furan-3-yl ester. Its molecular formula is C 27H 37N 3O 7S and its molecular weight is 547.67. Darunavir amorphous has the following structural formula:. Darunavir amorphous is an off-white to pale brown colored powder, freely soluble in chloroform and in dichloromethane. Darunavir 600 mg tablets are available as yellow, oval shaped, biconvex, film-coated tablets debossed with 'V' on one side and '5' on the other side. Each 600 mg tablet contains darunavir amorphous equivalent 600 mg of darunavir. Darunavir 800 mg tablets are available as yellow, oval shaped, biconvex, film-coated tablets debossed with 'V' on one side and '7' on the other side. Each 800 mg tablet contains darunavir amorphous equivalent 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, silicified microcrystalline cellulose. The film coating contains iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. All dosages for darunavir are expressed in terms of the free form of darunavir.</Description>
</NDC>
<NDC>
<NDCCode>40032-089-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (40032-089-03) </PackageDescription>
<NDC11Code>40032-0089-03</NDC11Code>
<ProductNDC>40032-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>40032-089-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (40032-089-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK (40032-089-30) </PackageDescription>
<NDC11Code>40032-0089-31</NDC11Code>
<ProductNDC>40032-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal drug indicated for use in the treatment of: : 1 Invasive aspergillosis (1.1), 2 Candidemia (non-neutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds (1.2), 3 Esophageal candidiasis (1.3), 4 Serious infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent, is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR, βS)-α-(2,4-Difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol with a molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to off-white crystalline powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>42254-089-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42254-089-30)</PackageDescription>
<NDC11Code>42254-0089-30</NDC11Code>
<ProductNDC>42254-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-089-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43353-089-30)</PackageDescription>
<NDC11Code>43353-0089-30</NDC11Code>
<ProductNDC>43353-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040301</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Warfarin sodium tablets, USP are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets, USP are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets, USP are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Crystalline warfarin sodium is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt and is a racemic mixture of theR- andS-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its empirical formula is C19H15NaO4, and its structural formula may be represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether. Warfarin Sodium Tablets, USP for oral use also contain.</Description>
</NDC>
<NDC>
<NDCCode>43386-089-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43386-089-03) </PackageDescription>
<NDC11Code>43386-0089-03</NDC11Code>
<ProductNDC>43386-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43386-089-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (43386-089-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-089-30) </PackageDescription>
<NDC11Code>43386-0089-31</NDC11Code>
<ProductNDC>43386-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207371</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4 triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Voriconazole Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch (maize starch), croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose (HPMC 2910), titanium dioxide, lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>46708-089-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-089-30)</PackageDescription>
<NDC11Code>46708-0089-30</NDC11Code>
<ProductNDC>46708-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202130</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>49349-089-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-089-02)</PackageDescription>
<NDC11Code>49349-0089-02</NDC11Code>
<ProductNDC>49349-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>49999-089-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (49999-089-30)</PackageDescription>
<NDC11Code>49999-0089-30</NDC11Code>
<ProductNDC>49999-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>51060-089-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51060-089-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51060-0089-01</NDC11Code>
<ProductNDC>51060-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Light Neutral</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tarte, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>62.3; 38.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51655-089-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, DISPENSING (51655-089-52)</PackageDescription>
<NDC11Code>51655-0089-52</NDC11Code>
<ProductNDC>51655-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA021210</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous). Inactive Ingredients. Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate, FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>52125-089-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (52125-089-02)</PackageDescription>
<NDC11Code>52125-0089-02</NDC11Code>
<ProductNDC>52125-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077627</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52343-089-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52343-089-30) </PackageDescription>
<NDC11Code>52343-0089-30</NDC11Code>
<ProductNDC>52343-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110531</StartMarketingDate>
<EndMarketingDate>20200101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090056</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110531</StartMarketingDatePackage>
<EndMarketingDatePackage>20200101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52959-089-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (52959-089-30)</PackageDescription>
<NDC11Code>52959-0089-30</NDC11Code>
<ProductNDC>52959-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levothyroxine sodium is used for the following indications.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown.</Description>
</NDC>
<NDC>
<NDCCode>54860-089-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (54860-089-01) </PackageDescription>
<NDC11Code>54860-0089-01</NDC11Code>
<ProductNDC>54860-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanilla Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Shenzhen Lantern Science Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60290-089-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (60290-089-01) </PackageDescription>
<NDC11Code>60290-0089-01</NDC11Code>
<ProductNDC>60290-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220717</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem N,N,6-trimethyl-2- p-tolylimidazo[ 1,2-a ]pyridine-3-acetamide L(+)-tartrate). It has the following structure:. Zolpidem tartrate is a white to off white powder, hygroscopic, that is slightly soluble in water, sparingly soluble in methanol, and practically insoluble in methylene chloride. It has a molecular formula of (C 19H 21N 3O) 2· C 4H 6O 6and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac, sodium starch glycolate, strong ammonium solution, titanium dioxide, and the colorants FD&C blue #1, FD&C red #40, FD&C yellow #5.</Description>
</NDC>
<NDC>
<NDCCode>60637-089-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (60637-089-30)</PackageDescription>
<NDC11Code>60637-0089-30</NDC11Code>
<ProductNDC>60637-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Justice Bff Go Together Like Unicorns Glitter Berry Scented Anti-bacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Tween Brands, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>620</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61722-089-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (61722-089-00) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>61722-0089-00</NDC11Code>
<ProductNDC>61722-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flormar Perfect Coverage Foundation Sunscreen Broad Spectrum Spf 15 114 Light Beige</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Kosan Kozmetik Sanayi ve Ticaret A.S.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140721</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>
</NDCList>