{
"NDC": [
{
"NDCCode": "69238-2261-3",
"PackageDescription": "80 mL in 1 BOTTLE (69238-2261-3) ",
"NDC11Code": "69238-2261-03",
"ProductNDC": "69238-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215338",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230626",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)."
},
{
"NDCCode": "69238-2261-5",
"PackageDescription": "300 mL in 1 BOTTLE (69238-2261-5) ",
"NDC11Code": "69238-2261-05",
"ProductNDC": "69238-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215338",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230626",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)."
},
{
"NDCCode": "69238-2261-7",
"PackageDescription": "150 mL in 1 BOTTLE (69238-2261-7) ",
"NDC11Code": "69238-2261-07",
"ProductNDC": "69238-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215338",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230626",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)."
},
{
"NDCCode": "36987-2261-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2261-3)",
"NDC11Code": "36987-2261-03",
"ProductNDC": "36987-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sisal",
"NonProprietaryName": "Sisal",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGAVE SISALANA FIBER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2261-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-2261-3) ",
"NDC11Code": "37662-2261-03",
"ProductNDC": "37662-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ruta Graveolens",
"NonProprietaryName": "Ruta Graveolens",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230106",
"SamplePackage": "N"
},
{
"NDCCode": "64942-2261-3",
"PackageDescription": "2 PACKAGE in 1 PACKAGE (64942-2261-3) / 2 CONTAINER in 1 PACKAGE (64942-2261-2) / 76 g in 1 CONTAINER (64942-2261-1) ",
"NDC11Code": "64942-2261-03",
"ProductNDC": "64942-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Axe",
"NonProprietaryName": "Anarchy Dark Pomegrante And Sandalwood 48h Antiperspirant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "18.2",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness.",
"Description": "Axe Dark Temptation 48H Anti Sweat Antiperspirant."
},
{
"NDCCode": "67296-2261-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (67296-2261-3) ",
"NDC11Code": "67296-2261-03",
"ProductNDC": "67296-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065435",
"LabelerName": "Redpharm Drug",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080429",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia) Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis) Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alphahemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "71335-2261-3",
"PackageDescription": "35 CAPSULE in 1 BOTTLE (71335-2261-3) ",
"NDC11Code": "71335-2261-03",
"ProductNDC": "71335-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204313",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231027",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulation for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Each acyclovir capsule intended for oral administration contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, FD & C blue # 1, FD & C red # 3, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "0781-2261-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2261-22)",
"NDC11Code": "00781-2261-22",
"ProductNDC": "0781-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2261-31",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0781-2261-31)",
"NDC11Code": "00781-2261-31",
"ProductNDC": "0781-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "17856-2261-1",
"PackageDescription": "72 mL in 1 BOX, UNIT-DOSE (17856-2261-1) ",
"NDC11Code": "17856-2261-01",
"ProductNDC": "17856-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214721",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250304",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride, USP in each 5 mL (1 teaspoonful). Dicyclomine Hydrochloride Oral Solution, USP also contains inactive ingredients: glycerin, methylparaben, propylene glycol, propylparaben, purified water, noncrystallizing sorbitol solution, sucrose, saccharin sodium with FD&C Red No. 3, FD&C Red No. 40 colors and fruit punch flavor."
},
{
"NDCCode": "17856-2261-2",
"PackageDescription": "72 mL in 1 BOX, UNIT-DOSE (17856-2261-2) ",
"NDC11Code": "17856-2261-02",
"ProductNDC": "17856-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214721",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250304",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride, USP in each 5 mL (1 teaspoonful). Dicyclomine Hydrochloride Oral Solution, USP also contains inactive ingredients: glycerin, methylparaben, propylene glycol, propylparaben, purified water, noncrystallizing sorbitol solution, sucrose, saccharin sodium with FD&C Red No. 3, FD&C Red No. 40 colors and fruit punch flavor."
},
{
"NDCCode": "43742-2261-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-2261-1) ",
"NDC11Code": "43742-2261-01",
"ProductNDC": "43742-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Addiclenz",
"NonProprietaryName": "Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum, Arsenicum Album, Beta Vulgaris, Bisphenol A, Boldo, Chelidonium Majus, Cobaltum Metallicum, Cuprum Metallicum, Glyphosate, Iodium, Lycopodium Clavatum, Petroselinum Sativum, Phosphoricum Acidum, Selenium Metallicum, Taraxacum Officinale, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250311",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE SOLUTION; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE, UNSPECIFIED FORM; TITANIUM DIOXIDE; ZINC OXIDE; ARSENIC TRIOXIDE; BETA VULGARIS WHOLE; BISPHENOL A; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS WHOLE; COBALT; COPPER; GLYPHOSATE; IODINE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM WHOLE; PHOSPHORIC ACID; SELENIUM; TARAXACUM OFFICINALE; ZINC",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12; 3; 12; 3; 3; 12; 12; 12; 12; 12; 3; 12; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Coagulation Factor Activity [PE], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Nitrogen Binding Agent [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250311",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. headache liver support muscle weakness. skin irritation poor muscle coordination. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "53002-2261-4",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (53002-2261-4) ",
"NDC11Code": "53002-2261-04",
"ProductNDC": "53002-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090836",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).",
"Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41.Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg."
},
{
"NDCCode": "55714-2261-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-2261-0)",
"NDC11Code": "55714-2261-00",
"ProductNDC": "55714-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea",
"NonProprietaryName": "Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-2261-1",
"PackageDescription": "28.35 g in 1 BOTTLE, GLASS (55714-2261-1)",
"NDC11Code": "55714-2261-01",
"ProductNDC": "55714-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea",
"NonProprietaryName": "Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-2261-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-2261-2)",
"NDC11Code": "55714-2261-02",
"ProductNDC": "55714-2261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea",
"NonProprietaryName": "Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69238-1017-3",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1) ",
"NDC11Code": "69238-1017-03",
"ProductNDC": "69238-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207792",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin capsules, USP contain 10 mg, 20 mg, 30 mg or 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide, and white wax (beeswax). In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake. Product meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1023-3",
"PackageDescription": "3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "69238-1023-03",
"ProductNDC": "69238-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211909",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.",
"Description": "Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s, USP chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine, USP is a white to almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; water for injection; and sodium hydroxide to adjust pH."
},
{
"NDCCode": "69238-1031-7",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) ",
"NDC11Code": "69238-1031-07",
"ProductNDC": "69238-1031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melodetta 24 Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207514",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170921",
"SamplePackage": "N",
"IndicationAndUsage": "Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. ."
},
{
"NDCCode": "69238-1050-3",
"PackageDescription": "3 BOTTLE in 1 CARTON (69238-1050-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-03",
"ProductNDC": "69238-1050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209716",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69238-1050-8",
"PackageDescription": "3 BOTTLE in 1 BLISTER PACK (69238-1050-8) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-08",
"ProductNDC": "69238-1050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209716",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69238-1051-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "69238-1051-03",
"ProductNDC": "69238-1051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209373",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. , 2 Hypoprothrombinemia secondary to antibacterial therapy. , 3 Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis., 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, very viscous, odorless or practically odourless liquid. It is soluble in dehydrated alcohol, benzene, chloroform and ether; slightly soluble in alcohol (96%) and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 1,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-,[R-[R*,R*-(E)]]. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc."
},
{
"NDCCode": "69238-1053-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1053-3) ",
"NDC11Code": "69238-1053-03",
"ProductNDC": "69238-1053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1055-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3) ",
"NDC11Code": "69238-1055-03",
"ProductNDC": "69238-1055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1057-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1057-3) ",
"NDC11Code": "69238-1057-03",
"ProductNDC": "69238-1057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1059-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1059-3) ",
"NDC11Code": "69238-1059-03",
"ProductNDC": "69238-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1061-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1061-3) ",
"NDC11Code": "69238-1061-03",
"ProductNDC": "69238-1061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1100-3",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (69238-1100-3) ",
"NDC11Code": "69238-1100-03",
"ProductNDC": "69238-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207289",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160628",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1104-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (69238-1104-3) ",
"NDC11Code": "69238-1104-03",
"ProductNDC": "69238-1104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiagabine Hydrochloride",
"NonProprietaryName": "Tiagabine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208181",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171208",
"SamplePackage": "N",
"IndicationAndUsage": "Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69238-2261-3</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (69238-2261-3) </PackageDescription>
<NDC11Code>69238-2261-03</NDC11Code>
<ProductNDC>69238-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215338</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).</Description>
</NDC>
<NDC>
<NDCCode>69238-2261-5</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE (69238-2261-5) </PackageDescription>
<NDC11Code>69238-2261-05</NDC11Code>
<ProductNDC>69238-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215338</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).</Description>
</NDC>
<NDC>
<NDCCode>69238-2261-7</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (69238-2261-7) </PackageDescription>
<NDC11Code>69238-2261-07</NDC11Code>
<ProductNDC>69238-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215338</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;. therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Oral Solution, USP contains chromatographically purified vancomycin hydrochloride USP, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride, USP is 1,485.73; 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Oral Solution, USP is intended for reconstitution with water. Each 5 mL of reconstituted solution contains vancomycin hydrochloride, USP equivalent to 250 mg (0.17 mmol) vancomycin, USP. Inactive ingredients: berry type flavor (arabic gum, corn maltodextrin, natural flavor), FD&C Red No. 40, malic acid, sodium benzoate, sodium phosphate monobasic anhydrous, and sucralose. Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).</Description>
</NDC>
<NDC>
<NDCCode>36987-2261-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2261-3)</PackageDescription>
<NDC11Code>36987-2261-03</NDC11Code>
<ProductNDC>36987-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sisal</ProprietaryName>
<NonProprietaryName>Sisal</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGAVE SISALANA FIBER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2261-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-2261-3) </PackageDescription>
<NDC11Code>37662-2261-03</NDC11Code>
<ProductNDC>37662-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ruta Graveolens</ProprietaryName>
<NonProprietaryName>Ruta Graveolens</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64942-2261-3</NDCCode>
<PackageDescription>2 PACKAGE in 1 PACKAGE (64942-2261-3) / 2 CONTAINER in 1 PACKAGE (64942-2261-2) / 76 g in 1 CONTAINER (64942-2261-1) </PackageDescription>
<NDC11Code>64942-2261-03</NDC11Code>
<ProductNDC>64942-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Axe</ProprietaryName>
<NonProprietaryName>Anarchy Dark Pomegrante And Sandalwood 48h Antiperspirant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>18.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
<Description>Axe Dark Temptation 48H Anti Sweat Antiperspirant.</Description>
</NDC>
<NDC>
<NDCCode>67296-2261-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (67296-2261-3) </PackageDescription>
<NDC11Code>67296-2261-03</NDC11Code>
<ProductNDC>67296-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065435</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia) Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis) Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alphahemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-2261-3</NDCCode>
<PackageDescription>35 CAPSULE in 1 BOTTLE (71335-2261-3) </PackageDescription>
<NDC11Code>71335-2261-03</NDC11Code>
<ProductNDC>71335-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204313</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulation for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. Each acyclovir capsule intended for oral administration contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, FD & C blue # 1, FD & C red # 3, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0781-2261-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2261-22)</PackageDescription>
<NDC11Code>00781-2261-22</NDC11Code>
<ProductNDC>0781-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2261-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0781-2261-31)</PackageDescription>
<NDC11Code>00781-2261-31</NDC11Code>
<ProductNDC>0781-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>17856-2261-1</NDCCode>
<PackageDescription>72 mL in 1 BOX, UNIT-DOSE (17856-2261-1) </PackageDescription>
<NDC11Code>17856-2261-01</NDC11Code>
<ProductNDC>17856-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214721</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride, USP in each 5 mL (1 teaspoonful). Dicyclomine Hydrochloride Oral Solution, USP also contains inactive ingredients: glycerin, methylparaben, propylene glycol, propylparaben, purified water, noncrystallizing sorbitol solution, sucrose, saccharin sodium with FD&C Red No. 3, FD&C Red No. 40 colors and fruit punch flavor.</Description>
</NDC>
<NDC>
<NDCCode>17856-2261-2</NDCCode>
<PackageDescription>72 mL in 1 BOX, UNIT-DOSE (17856-2261-2) </PackageDescription>
<NDC11Code>17856-2261-02</NDC11Code>
<ProductNDC>17856-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214721</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: 1 Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg dicyclomine hydrochloride, USP in each 5 mL (1 teaspoonful). Dicyclomine Hydrochloride Oral Solution, USP also contains inactive ingredients: glycerin, methylparaben, propylene glycol, propylparaben, purified water, noncrystallizing sorbitol solution, sucrose, saccharin sodium with FD&C Red No. 3, FD&C Red No. 40 colors and fruit punch flavor.</Description>
</NDC>
<NDC>
<NDCCode>43742-2261-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-2261-1) </PackageDescription>
<NDC11Code>43742-2261-01</NDC11Code>
<ProductNDC>43742-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Addiclenz</ProprietaryName>
<NonProprietaryName>Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum, Arsenicum Album, Beta Vulgaris, Bisphenol A, Boldo, Chelidonium Majus, Cobaltum Metallicum, Cuprum Metallicum, Glyphosate, Iodium, Lycopodium Clavatum, Petroselinum Sativum, Phosphoricum Acidum, Selenium Metallicum, Taraxacum Officinale, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250311</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE SOLUTION; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE, UNSPECIFIED FORM; TITANIUM DIOXIDE; ZINC OXIDE; ARSENIC TRIOXIDE; BETA VULGARIS WHOLE; BISPHENOL A; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS WHOLE; COBALT; COPPER; GLYPHOSATE; IODINE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM WHOLE; PHOSPHORIC ACID; SELENIUM; TARAXACUM OFFICINALE; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12; 3; 12; 3; 3; 12; 12; 12; 12; 12; 3; 12; 12; 3; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Coagulation Factor Activity [PE], Decreased Copper Ion Absorption [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Nitrogen Binding Agent [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of symptoms including. headache liver support muscle weakness. skin irritation poor muscle coordination. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53002-2261-4</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (53002-2261-4) </PackageDescription>
<NDC11Code>53002-2261-04</NDC11Code>
<ProductNDC>53002-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090836</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
<Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41.Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.</Description>
</NDC>
<NDC>
<NDCCode>55714-2261-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-2261-0)</PackageDescription>
<NDC11Code>55714-2261-00</NDC11Code>
<ProductNDC>55714-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea</ProprietaryName>
<NonProprietaryName>Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2261-1</NDCCode>
<PackageDescription>28.35 g in 1 BOTTLE, GLASS (55714-2261-1)</PackageDescription>
<NDC11Code>55714-2261-01</NDC11Code>
<ProductNDC>55714-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea</ProprietaryName>
<NonProprietaryName>Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2261-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-2261-2)</PackageDescription>
<NDC11Code>55714-2261-02</NDC11Code>
<ProductNDC>55714-2261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea</ProprietaryName>
<NonProprietaryName>Pyrogenium, Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Podoph. Pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus Hipp., Juglans Regia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69238-1017-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1) </PackageDescription>
<NDC11Code>69238-1017-03</NDC11Code>
<ProductNDC>69238-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207792</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin capsules, USP contain 10 mg, 20 mg, 30 mg or 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide, and white wax (beeswax). In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake. Product meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1023-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>69238-1023-03</NDC11Code>
<ProductNDC>69238-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211909</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
<Description>Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s, USP chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine, USP is a white to almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; water for injection; and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69238-1031-7</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) </PackageDescription>
<NDC11Code>69238-1031-07</NDC11Code>
<ProductNDC>69238-1031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melodetta 24 Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207514</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. .</Description>
</NDC>
<NDC>
<NDCCode>69238-1050-3</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (69238-1050-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-03</NDC11Code>
<ProductNDC>69238-1050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209716</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1050-8</NDCCode>
<PackageDescription>3 BOTTLE in 1 BLISTER PACK (69238-1050-8) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-08</NDC11Code>
<ProductNDC>69238-1050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209716</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1051-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69238-1051-03</NDC11Code>
<ProductNDC>69238-1051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209373</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. , 2 Hypoprothrombinemia secondary to antibacterial therapy. , 3 Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis., 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, very viscous, odorless or practically odourless liquid. It is soluble in dehydrated alcohol, benzene, chloroform and ether; slightly soluble in alcohol (96%) and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 1,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-,[R-[R*,R*-(E)]]. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc.</Description>
</NDC>
<NDC>
<NDCCode>69238-1053-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1053-3) </PackageDescription>
<NDC11Code>69238-1053-03</NDC11Code>
<ProductNDC>69238-1053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1055-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3) </PackageDescription>
<NDC11Code>69238-1055-03</NDC11Code>
<ProductNDC>69238-1055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1057-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1057-3) </PackageDescription>
<NDC11Code>69238-1057-03</NDC11Code>
<ProductNDC>69238-1057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1059-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1059-3) </PackageDescription>
<NDC11Code>69238-1059-03</NDC11Code>
<ProductNDC>69238-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1061-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1061-3) </PackageDescription>
<NDC11Code>69238-1061-03</NDC11Code>
<ProductNDC>69238-1061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1100-3</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (69238-1100-3) </PackageDescription>
<NDC11Code>69238-1100-03</NDC11Code>
<ProductNDC>69238-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207289</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1104-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69238-1104-3) </PackageDescription>
<NDC11Code>69238-1104-03</NDC11Code>
<ProductNDC>69238-1104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208181</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
</NDCList>