{
"NDC": [
{
"NDCCode": "69238-2017-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (69238-2017-2) / 165 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "69238-2017-02",
"ProductNDC": "69238-2017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215105",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "42",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide Nasal Solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.",
"Description": "The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (endo,syn)-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is. C20H30BrNO3H2O ipratropium bromide, USP Mol. Wt. 430.4. Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH-adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 165 sprays."
},
{
"NDCCode": "0363-1500-01",
"PackageDescription": "1 KIT in 1 CASE (0363-1500-01) * .9 g in 1 POUCH (61010-5600-1) * .34 g in 1 POUCH (51142-445-21) * .9 g in 1 POUCH (61010-5800-1) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) * .9 g in 1 PACKET (61010-5701-3) ",
"NDC11Code": "00363-1500-01",
"ProductNDC": "0363-1500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens",
"NonProprietaryName": "Diphenhydramine Hydrochloride, Ibuprofen, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Lidocaine Hcl, Benzalkonium Chloride, Isopropyl Alcohol, Ethyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20240717",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Walgreen Co.",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N"
},
{
"NDCCode": "36987-2017-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2017-2)",
"NDC11Code": "36987-2017-02",
"ProductNDC": "36987-2017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurospora Intermedia",
"NonProprietaryName": "Neurospora Intermedia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "NEUROSPORA INTERMEDIA",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal 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": "37662-2017-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-2017-2) ",
"NDC11Code": "37662-2017-02",
"ProductNDC": "37662-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viola Tricolor",
"NonProprietaryName": "Viola Tricolor",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "VIOLA TRICOLOR WHOLE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221129",
"SamplePackage": "N"
},
{
"NDCCode": "43742-0960-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0960-1) ",
"NDC11Code": "43742-0960-01",
"ProductNDC": "43742-0960",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Virus Plus",
"NonProprietaryName": "Influenzinum (2016-2017), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170106",
"EndMarketingDate": "20220628",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HEPATITIS B VIRUS; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); NORWALK VIRUS",
"StrengthNumber": "33; 15; 15; 15; 15; 18; 18; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Influenza A Virus Vaccine [EPC], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Influenza Vaccines [CS], Live Human Adenovirus Type 4 Vaccine [EPC], Live Human Adenovirus Type 7 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Live, Unattenuated [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-06-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170106",
"EndMarketingDatePackage": "20220628",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1117-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1117-1) ",
"NDC11Code": "43742-1117-01",
"ProductNDC": "43742-1117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Virus Plus",
"NonProprietaryName": "Influenzinum (2017-2018), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171214",
"EndMarketingDate": "20230822",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HEPATITIS B VIRUS; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); NORWALK VIRUS",
"StrengthNumber": "33; 15; 15; 15; 15; 18; 18; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Live Human Adenovirus Type 4 Vaccine [EPC], Live Human Adenovirus Type 7 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Inactivated [CS], Vaccines, Live, Unattenuated [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2023-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171214",
"EndMarketingDatePackage": "20230822",
"SamplePackage": "N"
},
{
"NDCCode": "48951-2017-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-2017-2) ",
"NDC11Code": "48951-2017-02",
"ProductNDC": "48951-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bambusa Rhus",
"NonProprietaryName": "Bambusa Rhus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; SILVER; STACHYS OFFICINALIS; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 20; 6; 8; 7; 4; 6; 10; 4; 6; 12; 20; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "51142-002-01",
"PackageDescription": "1 KIT in 1 CASE (51142-002-01) * .34 g in 1 POUCH (51142-445-21) * 2 TABLET, COATED in 1 PACKET (47682-803-99) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .034 L in 1 POUCH (61010-1112-1) * 30 mL in 1 BOTTLE, DISPENSING (47682-198-28) * .9 g in 1 POUCH (61010-5800-1) * .9 g in 1 POUCH (61010-5600-1) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) ",
"NDC11Code": "51142-0002-01",
"ProductNDC": "51142-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care Science Osha First Aid",
"NonProprietaryName": "Ethyl Alcohol, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Diphenhydramine Hydrochloride, Hydrocortisone, Ibuprofen, Acetaminophen, Water",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20230720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ASO LLC",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230720",
"SamplePackage": "N"
},
{
"NDCCode": "51142-005-01",
"PackageDescription": "1 KIT in 1 CASE (51142-005-01) * .9 g in 1 POUCH (61010-5600-1) * .34 g in 1 POUCH (51142-445-21) * .9 g in 1 POUCH (61010-5800-1) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) * .9 g in 1 PACKET (61010-5701-3) ",
"NDC11Code": "51142-0005-01",
"ProductNDC": "51142-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care Science",
"NonProprietaryName": "Diphenhydramine Hydrochloride, Ibuprofen, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Lidocaine Hcl, Benzalkonium Chloride, Isopropyl Alcohol, Ethyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20250507",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ASO LLC",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250507",
"SamplePackage": "N"
},
{
"NDCCode": "55898-2017-2",
"PackageDescription": "25 kg in 1 DRUM (55898-2017-2)",
"NDC11Code": "55898-2017-02",
"ProductNDC": "55898-2017",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Colloidal Bismuth Subcitrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101020",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Farmaquimia, SA de CV",
"SubstanceName": "BISMUTH CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63083-2017-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2017-2) ",
"NDC11Code": "63083-2017-02",
"ProductNDC": "63083-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degex Drops",
"ProprietaryNameSuffix": "2017",
"NonProprietaryName": "Degex Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "AMERICAN GINSENG; ACTIVATED CHARCOAL; GALIUM APARINE WHOLE; SELENIUM; AVISCUMINE; UBIDECARENONE; GERMANIUM",
"StrengthNumber": "4; 6; 6; 6; 6; 8; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "65517-2017-2",
"PackageDescription": "24 g in 1 TUBE (65517-2017-2) ",
"NDC11Code": "65517-2017-02",
"ProductNDC": "65517-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dawnmist Fluoride",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20140117",
"EndMarketingDate": "20260725",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Dukal LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".22",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170714",
"EndMarketingDatePackage": "20260725",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "67938-2017-1",
"PackageDescription": "1 BOTTLE in 1 BOX (67938-2017-1) > 1500 mg in 1 BOTTLE (67938-2017-2)",
"NDC11Code": "67938-2017-01",
"ProductNDC": "67938-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flawless Finish Perfectly Nude Makeup Broad Spectrum Sunscreen Spf 15 Shade Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130717",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Elizabeth Arden, Inc",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "60; 18.9",
"StrengthUnit": "mg/1500mg; mg/1500mg",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "smooth onto face.",
"Description": "Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless."
},
{
"NDCCode": "68745-2017-2",
"PackageDescription": "1 CASE in 1 CARTON (68745-2017-2) > .8 g in 1 CASE",
"NDC11Code": "68745-2017-02",
"ProductNDC": "68745-2017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Les Beiges",
"ProprietaryNameSuffix": "Healthy Glow Sheer Colour, Broad Spectrum Spf 15 Sunscreen, No 20",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".84; .96",
"StrengthUnit": "g/12g; g/12g",
"Status": "Deprecated",
"LastUpdate": "2016-03-04"
},
{
"NDCCode": "69600-2017-2",
"PackageDescription": "1 kg in 1 DRUM (69600-2017-2)",
"NDC11Code": "69600-2017-02",
"ProductNDC": "69600-2017",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170501",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Chempro Pharma Private Limited",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70518-2017-2",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2017-2) ",
"NDC11Code": "70518-2017-02",
"ProductNDC": "70518-2017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230130",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "71335-2017-2",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-2) ",
"NDC11Code": "71335-2017-02",
"ProductNDC": "71335-2017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "72162-2017-2",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (72162-2017-2) ",
"NDC11Code": "72162-2017-02",
"ProductNDC": "72162-2017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230616",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "85512-2017-2",
"PackageDescription": "5 g in 1 BAG (85512-2017-2) ",
"NDC11Code": "85512-2017-02",
"ProductNDC": "85512-2017",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Gw1516",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "GW-501516",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JUN-25"
},
{
"NDCCode": "69238-1013-2",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (69238-1013-2) / 88 g in 1 BOTTLE, PUMP",
"NDC11Code": "69238-1013-02",
"ProductNDC": "69238-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL, METERED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207373",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "20.25",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190410",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. .",
"Description": "Testosterone gel 1.62% for topical use is a clear, colorless gel, free from lumps and foreign matter with homogeneous consistency and no phase separation containing testosterone, USP. Testosterone, USP is an androgen. Testosterone gel 1.62% is available in a metered-dose pump. The active pharmacologic ingredient in testosterone gel 1.62% is testosterone, USP. Testosterone, USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. The inactive ingredients in testosterone gel 1.62% are: carbopol 980, ethyl alcohol (alcohol 72.22% v/v), isopropyl myristate, purified water and sodium hydroxide."
},
{
"NDCCode": "69238-1050-2",
"PackageDescription": "2 BOTTLE in 1 CARTON (69238-1050-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-02",
"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": "69238-1050-9",
"PackageDescription": "2 BOTTLE in 1 BLISTER PACK (69238-1050-9) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-09",
"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": "69238-1063-2",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (69238-1063-2) ",
"NDC11Code": "69238-1063-02",
"ProductNDC": "69238-1063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20271130",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1100-2",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (69238-1100-2) ",
"NDC11Code": "69238-1100-02",
"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": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160628",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules 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. Treatment: Doxycycline is indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .",
"Description": "Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "69238-1118-2",
"PackageDescription": "180 TABLET in 1 BOTTLE (69238-1118-2) ",
"NDC11Code": "69238-1118-02",
"ProductNDC": "69238-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208829",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170524",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "69238-1202-2",
"PackageDescription": "4 POUCH in 1 CARTON (69238-1202-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "69238-1202-02",
"ProductNDC": "69238-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211586",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "5",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone."
},
{
"NDCCode": "69238-1203-2",
"PackageDescription": "4 POUCH in 1 CARTON (69238-1203-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "69238-1203-02",
"ProductNDC": "69238-1203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211586",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "10",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone."
},
{
"NDCCode": "69238-1204-2",
"PackageDescription": "4 POUCH in 1 CARTON (69238-1204-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "69238-1204-02",
"ProductNDC": "69238-1204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211586",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "15",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-23",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone."
},
{
"NDCCode": "69238-1205-2",
"PackageDescription": "4 POUCH in 1 CARTON (69238-1205-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "69238-1205-02",
"ProductNDC": "69238-1205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211586",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "20",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone."
},
{
"NDCCode": "69238-1271-2",
"PackageDescription": "1 TUBE in 1 CARTON (69238-1271-2) / 120 g in 1 TUBE",
"NDC11Code": "69238-1271-02",
"ProductNDC": "69238-1271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211111",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-05",
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"StartMarketingDatePackage": "20180731",
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"IndicationAndUsage": "Fluocinonide Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide Cream, USP, 0.1% contains fluocinonide, USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide, USP has the chemical name 6α, 9-Difluoro-11ß, 16α, 17,21-tetrahydroxypregna-1, 4-diene-3,20-dione, cyclic 16,17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide, USP is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream, USP 0.1% contains 1 mg micronized fluocinonide, USP in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate NF, purified water USP, carbomer homopolymer Type C NF (carbopol 980), diisopropanolamine, and anhydrous citric acid USP."
}
]
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<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69238-2017-2) / 165 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
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<ProductNDC>69238-2017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
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<IndicationAndUsage>Ipratropium Bromide Nasal Solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.</IndicationAndUsage>
<Description>The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (endo,syn)-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is. C20H30BrNO3H2O ipratropium bromide, USP Mol. Wt. 430.4. Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH-adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 165 sprays.</Description>
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<PackageDescription>1 KIT in 1 CASE (0363-1500-01) * .9 g in 1 POUCH (61010-5600-1) * .34 g in 1 POUCH (51142-445-21) * .9 g in 1 POUCH (61010-5800-1) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) * .9 g in 1 PACKET (61010-5701-3) </PackageDescription>
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<ProductNDC>0363-1500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride, Ibuprofen, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Lidocaine Hcl, Benzalkonium Chloride, Isopropyl Alcohol, Ethyl Alcohol</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20240717</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Walgreen Co.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>36987-2017-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2017-2)</PackageDescription>
<NDC11Code>36987-2017-02</NDC11Code>
<ProductNDC>36987-2017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurospora Intermedia</ProprietaryName>
<NonProprietaryName>Neurospora Intermedia</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>NEUROSPORA INTERMEDIA</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal 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>
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<NDCCode>37662-2017-2</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-2017-2) </PackageDescription>
<NDC11Code>37662-2017-02</NDC11Code>
<ProductNDC>37662-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viola Tricolor</ProprietaryName>
<NonProprietaryName>Viola Tricolor</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>VIOLA TRICOLOR WHOLE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>43742-0960-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0960-1) </PackageDescription>
<NDC11Code>43742-0960-01</NDC11Code>
<ProductNDC>43742-0960</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Virus Plus</ProprietaryName>
<NonProprietaryName>Influenzinum (2016-2017), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20170106</StartMarketingDate>
<EndMarketingDate>20220628</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>HEPATITIS B VIRUS; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); NORWALK VIRUS</SubstanceName>
<StrengthNumber>33; 15; 15; 15; 15; 18; 18; 12; 12; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Influenza A Virus Vaccine [EPC], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Influenza Vaccines [CS], Live Human Adenovirus Type 4 Vaccine [EPC], Live Human Adenovirus Type 7 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Live, Unattenuated [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170106</StartMarketingDatePackage>
<EndMarketingDatePackage>20220628</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1117-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1117-1) </PackageDescription>
<NDC11Code>43742-1117-01</NDC11Code>
<ProductNDC>43742-1117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Virus Plus</ProprietaryName>
<NonProprietaryName>Influenzinum (2017-2018), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171214</StartMarketingDate>
<EndMarketingDate>20230822</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>HEPATITIS B VIRUS; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); NORWALK VIRUS</SubstanceName>
<StrengthNumber>33; 15; 15; 15; 15; 18; 18; 12; 12; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Live Human Adenovirus Type 4 Vaccine [EPC], Live Human Adenovirus Type 7 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Inactivated [CS], Vaccines, Live, Unattenuated [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171214</StartMarketingDatePackage>
<EndMarketingDatePackage>20230822</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-2017-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-2017-2) </PackageDescription>
<NDC11Code>48951-2017-02</NDC11Code>
<ProductNDC>48951-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bambusa Rhus</ProprietaryName>
<NonProprietaryName>Bambusa Rhus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; SILVER; STACHYS OFFICINALIS; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 20; 6; 8; 7; 4; 6; 10; 4; 6; 12; 20; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51142-002-01</NDCCode>
<PackageDescription>1 KIT in 1 CASE (51142-002-01) * .34 g in 1 POUCH (51142-445-21) * 2 TABLET, COATED in 1 PACKET (47682-803-99) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .034 L in 1 POUCH (61010-1112-1) * 30 mL in 1 BOTTLE, DISPENSING (47682-198-28) * .9 g in 1 POUCH (61010-5800-1) * .9 g in 1 POUCH (61010-5600-1) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) </PackageDescription>
<NDC11Code>51142-0002-01</NDC11Code>
<ProductNDC>51142-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care Science Osha First Aid</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Diphenhydramine Hydrochloride, Hydrocortisone, Ibuprofen, Acetaminophen, Water</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ASO LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51142-005-01</NDCCode>
<PackageDescription>1 KIT in 1 CASE (51142-005-01) * .9 g in 1 POUCH (61010-5600-1) * .34 g in 1 POUCH (51142-445-21) * .9 g in 1 POUCH (61010-5800-1) * 2 TABLET, COATED in 1 PACKET (47682-718-99) * .0019 L in 1 PACKET (61010-2017-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) * .9 g in 1 PACKET (61010-5701-3) </PackageDescription>
<NDC11Code>51142-0005-01</NDC11Code>
<ProductNDC>51142-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care Science</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride, Ibuprofen, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin-b Sulfate, Lidocaine Hcl, Benzalkonium Chloride, Isopropyl Alcohol, Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ASO LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55898-2017-2</NDCCode>
<PackageDescription>25 kg in 1 DRUM (55898-2017-2)</PackageDescription>
<NDC11Code>55898-2017-02</NDC11Code>
<ProductNDC>55898-2017</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Colloidal Bismuth Subcitrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Farmaquimia, SA de CV</LabelerName>
<SubstanceName>BISMUTH CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63083-2017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2017-2) </PackageDescription>
<NDC11Code>63083-2017-02</NDC11Code>
<ProductNDC>63083-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degex Drops</ProprietaryName>
<ProprietaryNameSuffix>2017</ProprietaryNameSuffix>
<NonProprietaryName>Degex Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>AMERICAN GINSENG; ACTIVATED CHARCOAL; GALIUM APARINE WHOLE; SELENIUM; AVISCUMINE; UBIDECARENONE; GERMANIUM</SubstanceName>
<StrengthNumber>4; 6; 6; 6; 6; 8; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65517-2017-2</NDCCode>
<PackageDescription>24 g in 1 TUBE (65517-2017-2) </PackageDescription>
<NDC11Code>65517-2017-02</NDC11Code>
<ProductNDC>65517-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dawnmist Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<EndMarketingDate>20260725</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Dukal LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.22</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170714</StartMarketingDatePackage>
<EndMarketingDatePackage>20260725</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67938-2017-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (67938-2017-1) > 1500 mg in 1 BOTTLE (67938-2017-2)</PackageDescription>
<NDC11Code>67938-2017-01</NDC11Code>
<ProductNDC>67938-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flawless Finish Perfectly Nude Makeup Broad Spectrum Sunscreen Spf 15 Shade Beige</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130717</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Elizabeth Arden, Inc</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>60; 18.9</StrengthNumber>
<StrengthUnit>mg/1500mg; mg/1500mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>smooth onto face.</IndicationAndUsage>
<Description>Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless.</Description>
</NDC>
<NDC>
<NDCCode>68745-2017-2</NDCCode>
<PackageDescription>1 CASE in 1 CARTON (68745-2017-2) > .8 g in 1 CASE</PackageDescription>
<NDC11Code>68745-2017-02</NDC11Code>
<ProductNDC>68745-2017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Les Beiges</ProprietaryName>
<ProprietaryNameSuffix>Healthy Glow Sheer Colour, Broad Spectrum Spf 15 Sunscreen, No 20</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.84; .96</StrengthNumber>
<StrengthUnit>g/12g; g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-03-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>69600-2017-2</NDCCode>
<PackageDescription>1 kg in 1 DRUM (69600-2017-2)</PackageDescription>
<NDC11Code>69600-2017-02</NDC11Code>
<ProductNDC>69600-2017</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Chempro Pharma Private Limited</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-2017-2</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2017-2) </PackageDescription>
<NDC11Code>70518-2017-02</NDC11Code>
<ProductNDC>70518-2017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>71335-2017-2</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2017-2) </PackageDescription>
<NDC11Code>71335-2017-02</NDC11Code>
<ProductNDC>71335-2017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>72162-2017-2</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (72162-2017-2) </PackageDescription>
<NDC11Code>72162-2017-02</NDC11Code>
<ProductNDC>72162-2017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>85512-2017-2</NDCCode>
<PackageDescription>5 g in 1 BAG (85512-2017-2) </PackageDescription>
<NDC11Code>85512-2017-02</NDC11Code>
<ProductNDC>85512-2017</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Gw1516</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>GW-501516</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69238-1013-2</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (69238-1013-2) / 88 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>69238-1013-02</NDC11Code>
<ProductNDC>69238-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL, METERED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207373</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>20.25</StrengthNumber>
<StrengthUnit>mg/1.25g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. .</IndicationAndUsage>
<Description>Testosterone gel 1.62% for topical use is a clear, colorless gel, free from lumps and foreign matter with homogeneous consistency and no phase separation containing testosterone, USP. Testosterone, USP is an androgen. Testosterone gel 1.62% is available in a metered-dose pump. The active pharmacologic ingredient in testosterone gel 1.62% is testosterone, USP. Testosterone, USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. The inactive ingredients in testosterone gel 1.62% are: carbopol 980, ethyl alcohol (alcohol 72.22% v/v), isopropyl myristate, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>69238-1050-2</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (69238-1050-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-02</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>69238-1050-9</NDCCode>
<PackageDescription>2 BOTTLE in 1 BLISTER PACK (69238-1050-9) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-09</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>69238-1063-2</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (69238-1063-2) </PackageDescription>
<NDC11Code>69238-1063-02</NDC11Code>
<ProductNDC>69238-1063</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>20271130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>20271130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1100-2</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (69238-1100-2) </PackageDescription>
<NDC11Code>69238-1100-02</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>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules 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. Treatment: Doxycycline is indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
<Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69238-1118-2</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (69238-1118-2) </PackageDescription>
<NDC11Code>69238-1118-02</NDC11Code>
<ProductNDC>69238-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208829</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69238-1202-2</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (69238-1202-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>69238-1202-02</NDC11Code>
<ProductNDC>69238-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1203-2</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (69238-1203-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>69238-1203-02</NDC11Code>
<ProductNDC>69238-1203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1204-2</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (69238-1204-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>69238-1204-02</NDC11Code>
<ProductNDC>69238-1204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1205-2</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (69238-1205-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>69238-1205-02</NDC11Code>
<ProductNDC>69238-1205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211586</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14- ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: acrylic adhesive, levulinic acid, oleyl oleate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69238-1271-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69238-1271-2) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>69238-1271-02</NDC11Code>
<ProductNDC>69238-1271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211111</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide Cream, USP, 0.1% contains fluocinonide, USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide, USP has the chemical name 6α, 9-Difluoro-11ß, 16α, 17,21-tetrahydroxypregna-1, 4-diene-3,20-dione, cyclic 16,17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide, USP is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream, USP 0.1% contains 1 mg micronized fluocinonide, USP in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate NF, purified water USP, carbomer homopolymer Type C NF (carbopol 980), diisopropanolamine, and anhydrous citric acid USP.</Description>
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