{
"NDC": [
{
"NDCCode": "0019-9091-40",
"PackageDescription": "30 VIAL in 1 CARTON (0019-9091-40) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00019-9091-40",
"ProductNDC": "0019-9091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technescan Hdp",
"NonProprietaryName": "Technetium Tc 99m Oxidronate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070227",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018321",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "OXIDRONATE DISODIUM",
"StrengthNumber": "3.15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0019-9091-20",
"PackageDescription": "5 VIAL in 1 CELLO PACK (0019-9091-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00019-9091-20",
"ProductNDC": "0019-9091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technescan Hdp",
"NonProprietaryName": "Technetium Tc 99m Oxidronate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070227",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018321",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "OXIDRONATE DISODIUM",
"StrengthNumber": "3.15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "53002-9091-1",
"PackageDescription": "25 g in 1 TUBE (53002-9091-1) ",
"NDC11Code": "53002-9091-01",
"ProductNDC": "53002-9091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ssd",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018578",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
"StrengthUnit": "g/1000g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
"Description": "SSD (1% Silver Sulfadiazine Cream) and SSD AF (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown."
},
{
"NDCCode": "53002-9091-2",
"PackageDescription": "50 g in 1 TUBE (53002-9091-2) ",
"NDC11Code": "53002-9091-02",
"ProductNDC": "53002-9091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ssd",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018578",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
"StrengthUnit": "g/1000g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
"Description": "SSD (1% Silver Sulfadiazine Cream) and SSD AF (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown."
},
{
"NDCCode": "63629-9091-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (63629-9091-1) ",
"NDC11Code": "63629-9091-01",
"ProductNDC": "63629-9091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078423",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241008",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Tablets are indicated for the treatment of: 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole Tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 3.Cryptococcal meningitis. Before prescribing Fluconazole Tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Each Fluconazole Tablet USP contains either 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0019-9050-40",
"PackageDescription": "1 KIT in 1 BOX (0019-9050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00019-9050-40",
"ProductNDC": "0019-9050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreoscan",
"NonProprietaryName": "Indium In -111 Pentetreotide",
"DosageFormName": "KIT",
"StartMarketingDate": "20070501",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020314",
"LabelerName": "Mallinckrodt Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0019-9092-40",
"PackageDescription": "30 VIAL in 1 CARTON (0019-9092-40) > 10 mL in 1 VIAL",
"NDC11Code": "00019-9092-40",
"ProductNDC": "0019-9092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technetium Tc 99m Sestamibi",
"NonProprietaryName": "Technetium Tc 99m Sestamibi",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111031",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078098",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "TECHNETIUM TC-99M SESTAMIBI",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0113-0019-40",
"PackageDescription": "354 mL in 1 BOTTLE (0113-0019-40) ",
"NDC11Code": "00113-0019-40",
"ProductNDC": "0113-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Severe Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151021",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151124",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion and pressure, 3 minor aches and pains, 4 headache, 5 fever, 6 sore throat, 7 runny nose and sneezing, 8 cough due to minor throat and bronchial irritation, 9 cough to help you sleep, 10 reduces swelling of nasal passages, 11 promotes nasal and/or sinus drainage, 12 temporarily restores freer breathing through the nose."
},
{
"NDCCode": "0363-0019-40",
"PackageDescription": "355 mL in 1 BOTTLE (0363-0019-40) ",
"NDC11Code": "00363-0019-40",
"ProductNDC": "0363-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough",
"NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140210",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walgreen Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160330",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cold symptoms: 1 cough due to minor throat and bronchial irritation, 2 runny nose and sneezing."
},
{
"NDCCode": "0363-0444-02",
"PackageDescription": "1 KIT in 1 KIT (0363-0444-02) * 355 mL in 1 BOTTLE (0363-0019-40) * 355 mL in 1 BOTTLE (0363-0500-40) ",
"NDC11Code": "00363-0444-02",
"ProductNDC": "0363-0444",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Daytime Cough",
"NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "KIT",
"StartMarketingDate": "20140225",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"Status": "Deprecated",
"LastUpdate": "2023-03-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140225",
"SamplePackage": "N"
},
{
"NDCCode": "11410-019-40",
"PackageDescription": "120 mL in 1 BOTTLE (11410-019-40)",
"NDC11Code": "11410-0019-40",
"ProductNDC": "11410-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Revitalizing Toner Combination Therapy Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11673-019-40",
"PackageDescription": "355 mL in 1 BOTTLE (11673-019-40) ",
"NDC11Code": "11673-0019-40",
"ProductNDC": "11673-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150310",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Target Corporation",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150310",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing."
},
{
"NDCCode": "19661-0019-2",
"PackageDescription": "1 BAG in 1 DRUM (19661-0019-2) / 40 kg in 1 BAG",
"NDC11Code": "19661-0019-02",
"ProductNDC": "19661-0019",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Thyroid, U.s.p.",
"DosageFormName": "POWDER",
"StartMarketingDate": "19680719",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "American Laboratories Pharma, LLC",
"SubstanceName": "SUS SCROFA THYROID",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-06-29",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19-JUL-68"
},
{
"NDCCode": "43835-0019-1",
"PackageDescription": "40 CARTON in 1 BOX (43835-0019-1) > 10 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "43835-0019-01",
"ProductNDC": "43835-0019",
"ProductTypeName": "LICENSED VACCINE BULK INTERMEDIATE",
"ProprietaryName": "Fluvirin",
"NonProprietaryName": "A/singapore/gp1908/2015 Ivr-180 (an A/michigan/45/2015 (h1n1)pdm09-like Virus, A/hong Kong/4801/2014, Nymc X-263b (h3n2) (an A/hong Kong/4801/2014-like Virus), And B/brisbane/60/2008, Wild Type (a B/brisbane/60/2008-like Virus)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "NOT APPLICABLE",
"StartMarketingDate": "20130915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103837",
"LabelerName": "Catalent Belgium SA",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130915",
"SamplePackage": "N"
},
{
"NDCCode": "49715-019-40",
"PackageDescription": "40 g in 1 BOTTLE, PLASTIC (49715-019-40)",
"NDC11Code": "49715-0019-40",
"ProductNDC": "49715-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin79 Snail Nutrition Bbcream",
"NonProprietaryName": "Snail Secretion Filtrate Titanium Dioxide Zinc Oxide Arbutin Adenosine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "WIZCOZ CORPORATION LTD",
"SubstanceName": "SNAIL, UNSPECIFIED; TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE",
"StrengthNumber": "18.05; 3.6; 2.52; .8; .016",
"StrengthUnit": "g/40g; g/40g; g/40g; g/40g; g/40g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55289-019-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-40) ",
"NDC11Code": "55289-0019-40",
"ProductNDC": "55289-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111128",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension:Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable):Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules:Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "58414-0019-1",
"PackageDescription": "1 TUBE in 1 CARTON (58414-0019-1) / 40 g in 1 TUBE",
"NDC11Code": "58414-0019-01",
"ProductNDC": "58414-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neostrata Enlighten Skin Brightener",
"ProprietaryNameSuffix": "With Sunscreen Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Octisalate, And Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "NeoStrata Company Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; AVOBENZONE",
"StrengthNumber": "75; 50; 30",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63187-019-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (63187-019-40) ",
"NDC11Code": "63187-0019-40",
"ProductNDC": "63187-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090200",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140401",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid."
},
{
"NDCCode": "64330-019-40",
"PackageDescription": "2.3 kg in 1 DRUM (64330-019-40) ",
"NDC11Code": "64330-0019-40",
"ProductNDC": "64330-019",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090217",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2025-07-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-MAY-19"
},
{
"NDCCode": "65862-019-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (65862-019-40) ",
"NDC11Code": "65862-0019-40",
"ProductNDC": "65862-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065253",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051116",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection (1.1) , 2 Otitis media (1.2) , 3 Skin and skin structure infections (1.3) , 4 Bone infections (1.4) , 5 Genitourinary tract infections (1.5).",
"Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate. FDA approved dissolution test specifications differs from the USP."
},
{
"NDCCode": "67544-019-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (67544-019-40) ",
"NDC11Code": "67544-0019-40",
"ProductNDC": "67544-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071135",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for 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. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
},
{
"NDCCode": "70954-019-40",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (70954-019-40) / 1 CAPSULE in 1 BLISTER PACK (70954-019-30) ",
"NDC11Code": "70954-0019-40",
"ProductNDC": "70954-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210971",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210413",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "71205-019-40",
"PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE (71205-019-40) ",
"NDC11Code": "71205-0019-40",
"ProductNDC": "71205-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200958",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablet, 500 mg is available as an orange, film coated, round convex tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide."
},
{
"NDCCode": "74279-0019-1",
"PackageDescription": "40 mL in 1 BOTTLE, SPRAY (74279-0019-1) ",
"NDC11Code": "74279-0019-01",
"ProductNDC": "74279-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nature Hand Touch Cherry (ethanol) 70% 40ml",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210512",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Dai Kyoung Pharmaceutic Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "28",
"StrengthUnit": "mL/40mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210512",
"SamplePackage": "N",
"IndicationAndUsage": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing."
},
{
"NDCCode": "75109-019-40",
"PackageDescription": "1 KIT in 1 KIT (75109-019-40) * 40 SWAB in 1 POUCH (75109-008-40) * 40 SWAB in 1 POUCH (75109-010-40) * 40 SWAB in 1 POUCH (75109-007-40) ",
"NDC11Code": "75109-0019-40",
"ProductNDC": "75109-019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin-aid-medics Antibacterial Wipes Kit Fresh, Citrus, Berry",
"NonProprietaryName": "Benzalkonium Chloride Kit",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "13668-019-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-01) ",
"NDC11Code": "13668-0019-01",
"ProductNDC": "13668-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110106",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090899",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110106",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5."
},
{
"NDCCode": "13668-019-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-05) ",
"NDC11Code": "13668-0019-05",
"ProductNDC": "13668-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110106",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090899",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110106",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5."
},
{
"NDCCode": "13668-019-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-30) ",
"NDC11Code": "13668-0019-30",
"ProductNDC": "13668-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110106",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090899",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110106",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5."
},
{
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"PackageDescription": "850 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-46) ",
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"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5."
},
{
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"ProductNDC": "13668-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5."
}
]
}
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<PackageDescription>5 VIAL in 1 CELLO PACK (0019-9091-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
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<LabelerName>Mallinckrodt Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
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<NDC>
<NDCCode>53002-9091-1</NDCCode>
<PackageDescription>25 g in 1 TUBE (53002-9091-1) </PackageDescription>
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<LastUpdate>2025-01-01</LastUpdate>
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<Description>SSD (1% Silver Sulfadiazine Cream) and SSD AF (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown.</Description>
</NDC>
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<ProductNDC>53002-9091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ssd</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<StrengthUnit>g/1000g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.</IndicationAndUsage>
<Description>SSD (1% Silver Sulfadiazine Cream) and SSD AF (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown.</Description>
</NDC>
<NDC>
<NDCCode>63629-9091-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63629-9091-1) </PackageDescription>
<NDC11Code>63629-9091-01</NDC11Code>
<ProductNDC>63629-9091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078423</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Tablets are indicated for the treatment of: 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole Tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 3.Cryptococcal meningitis. Before prescribing Fluconazole Tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Each Fluconazole Tablet USP contains either 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
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<ProprietaryName>Octreoscan</ProprietaryName>
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<EndMarketingDate>20170701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020314</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078098</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SESTAMIBI</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
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<StartMarketingDate>20151021</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
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<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion and pressure, 3 minor aches and pains, 4 headache, 5 fever, 6 sore throat, 7 runny nose and sneezing, 8 cough due to minor throat and bronchial irritation, 9 cough to help you sleep, 10 reduces swelling of nasal passages, 11 promotes nasal and/or sinus drainage, 12 temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
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<NDC11Code>00363-0019-40</NDC11Code>
<ProductNDC>0363-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140210</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160330</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cold symptoms: 1 cough due to minor throat and bronchial irritation, 2 runny nose and sneezing.</IndicationAndUsage>
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<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-03-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-019-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (11673-019-40) </PackageDescription>
<NDC11Code>11673-0019-40</NDC11Code>
<ProductNDC>11673-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150310</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150310</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>19661-0019-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (19661-0019-2) / 40 kg in 1 BAG</PackageDescription>
<NDC11Code>19661-0019-02</NDC11Code>
<ProductNDC>19661-0019</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Thyroid, U.s.p.</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19680719</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>American Laboratories Pharma, LLC</LabelerName>
<SubstanceName>SUS SCROFA THYROID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-29</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-JUL-68</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43835-0019-1</NDCCode>
<PackageDescription>40 CARTON in 1 BOX (43835-0019-1) > 10 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>43835-0019-01</NDC11Code>
<ProductNDC>43835-0019</ProductNDC>
<ProductTypeName>LICENSED VACCINE BULK INTERMEDIATE</ProductTypeName>
<ProprietaryName>Fluvirin</ProprietaryName>
<NonProprietaryName>A/singapore/gp1908/2015 Ivr-180 (an A/michigan/45/2015 (h1n1)pdm09-like Virus, A/hong Kong/4801/2014, Nymc X-263b (h3n2) (an A/hong Kong/4801/2014-like Virus), And B/brisbane/60/2008, Wild Type (a B/brisbane/60/2008-like Virus)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>NOT APPLICABLE</RouteName>
<StartMarketingDate>20130915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103837</ApplicationNumber>
<LabelerName>Catalent Belgium SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49715-019-40</NDCCode>
<PackageDescription>40 g in 1 BOTTLE, PLASTIC (49715-019-40)</PackageDescription>
<NDC11Code>49715-0019-40</NDC11Code>
<ProductNDC>49715-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin79 Snail Nutrition Bbcream</ProprietaryName>
<NonProprietaryName>Snail Secretion Filtrate Titanium Dioxide Zinc Oxide Arbutin Adenosine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>WIZCOZ CORPORATION LTD</LabelerName>
<SubstanceName>SNAIL, UNSPECIFIED; TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE</SubstanceName>
<StrengthNumber>18.05; 3.6; 2.52; .8; .016</StrengthNumber>
<StrengthUnit>g/40g; g/40g; g/40g; g/40g; g/40g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-019-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE, PLASTIC (55289-019-40) </PackageDescription>
<NDC11Code>55289-0019-40</NDC11Code>
<ProductNDC>55289-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. , 4 Infections of the Lower Respiratory Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Tablets:Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension:Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable):Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules:Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>58414-0019-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58414-0019-1) / 40 g in 1 TUBE</PackageDescription>
<NDC11Code>58414-0019-01</NDC11Code>
<ProductNDC>58414-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neostrata Enlighten Skin Brightener</ProprietaryName>
<ProprietaryNameSuffix>With Sunscreen Broad Spectrum Spf 35</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>NeoStrata Company Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; AVOBENZONE</SubstanceName>
<StrengthNumber>75; 50; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-019-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (63187-019-40) </PackageDescription>
<NDC11Code>63187-0019-40</NDC11Code>
<ProductNDC>63187-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090200</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>64330-019-40</NDCCode>
<PackageDescription>2.3 kg in 1 DRUM (64330-019-40) </PackageDescription>
<NDC11Code>64330-0019-40</NDC11Code>
<ProductNDC>64330-019</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20090217</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-07-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-MAY-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-019-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (65862-019-40) </PackageDescription>
<NDC11Code>65862-0019-40</NDC11Code>
<ProductNDC>65862-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065253</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 1 Respiratory tract infection (1.1) , 2 Otitis media (1.2) , 3 Skin and skin structure infections (1.3) , 4 Bone infections (1.4) , 5 Genitourinary tract infections (1.5).</IndicationAndUsage>
<Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate. FDA approved dissolution test specifications differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>67544-019-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (67544-019-40) </PackageDescription>
<NDC11Code>67544-0019-40</NDC11Code>
<ProductNDC>67544-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071135</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for 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. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>70954-019-40</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (70954-019-40) / 1 CAPSULE in 1 BLISTER PACK (70954-019-30) </PackageDescription>
<NDC11Code>70954-0019-40</NDC11Code>
<ProductNDC>70954-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210971</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-019-40</NDCCode>
<PackageDescription>40 TABLET, FILM COATED in 1 BOTTLE (71205-019-40) </PackageDescription>
<NDC11Code>71205-0019-40</NDC11Code>
<ProductNDC>71205-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200958</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablet, 500 mg is available as an orange, film coated, round convex tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>74279-0019-1</NDCCode>
<PackageDescription>40 mL in 1 BOTTLE, SPRAY (74279-0019-1) </PackageDescription>
<NDC11Code>74279-0019-01</NDC11Code>
<ProductNDC>74279-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nature Hand Touch Cherry (ethanol) 70% 40ml</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Dai Kyoung Pharmaceutic Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mL/40mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75109-019-40</NDCCode>
<PackageDescription>1 KIT in 1 KIT (75109-019-40) * 40 SWAB in 1 POUCH (75109-008-40) * 40 SWAB in 1 POUCH (75109-010-40) * 40 SWAB in 1 POUCH (75109-007-40) </PackageDescription>
<NDC11Code>75109-0019-40</NDC11Code>
<ProductNDC>75109-019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin-aid-medics Antibacterial Wipes Kit Fresh, Citrus, Berry</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-019-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-01) </PackageDescription>
<NDC11Code>13668-0019-01</NDC11Code>
<ProductNDC>13668-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090899</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>13668-019-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-05) </PackageDescription>
<NDC11Code>13668-0019-05</NDC11Code>
<ProductNDC>13668-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090899</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>13668-019-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-30) </PackageDescription>
<NDC11Code>13668-0019-30</NDC11Code>
<ProductNDC>13668-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090899</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>13668-019-46</NDCCode>
<PackageDescription>850 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-46) </PackageDescription>
<NDC11Code>13668-0019-46</NDC11Code>
<ProductNDC>13668-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090899</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>13668-019-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-019-90) </PackageDescription>
<NDC11Code>13668-0019-90</NDC11Code>
<ProductNDC>13668-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110106</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090899</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110106</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: 1 Major Depressive Disorder (MDD) ( 1) , 2 Generalized Anxiety Disorder (GAD) ( 1) , 3 Social Anxiety Disorder (SAD) ( 1) , 4 Panic Disorder (PD) ( 1) .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, sodium lauryl sulphate, sugar spheres, talc and titanium dioxide. Additionally, the 37.5 mg capsule contains iron oxide (black, red & yellow), the 75 mg capsule contains FD&C Blue No.1 and FD&C Yellow No.5 and the 150 mg capsule contains FD&C Red No. 40 and FD&C Yellow No. 5. Sugar spheres contains sucrose and corn starch. Venlafaxine hydrochloride extended-release capsules, USP, 37.5 mg, 75 mg and 150 mg meet USP dissolution test 5.</Description>
</NDC>
</NDCList>