{
"NDC": [
{
"NDCCode": "49483-699-26",
"PackageDescription": "225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) ",
"NDC11Code": "49483-0699-26",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221107",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "36800-699-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-699-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "36800-0699-26",
"ProductNDC": "36800-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Childrens Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19970826",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19970826",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache , 6 sore throat, 7 toothache."
},
{
"NDCCode": "41226-699-26",
"PackageDescription": "225 TABLET, EXTENDED RELEASE in 1 BOTTLE (41226-699-26) ",
"NDC11Code": "41226-0699-26",
"ProductNDC": "41226-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250605",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "69842-699-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "69842-0699-26",
"ProductNDC": "69842-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "30; 12.5",
"StrengthUnit": "mg/20mL; mg/20mL",
"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": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180625",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. controls the impulse to cough to help you sleep."
},
{
"NDCCode": "69842-929-12",
"PackageDescription": "1 KIT in 1 CARTON (69842-929-12) * 1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69842-819-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "69842-0929-12",
"ProductNDC": "69842-929",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Dm Max Daytime Nighttime",
"NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate, Guaifesesin",
"DosageFormName": "KIT",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180720",
"SamplePackage": "N"
},
{
"NDCCode": "49483-699-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) ",
"NDC11Code": "49483-0699-01",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211004",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "49483-699-05",
"PackageDescription": "50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "49483-0699-05",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211004",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "49483-699-40",
"PackageDescription": "400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) ",
"NDC11Code": "49483-0699-40",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211004",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "49483-699-42",
"PackageDescription": "1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "49483-0699-42",
"ProductNDC": "49483-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "TIME CAP LABORATORIES, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221107",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "10135-699-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-699-01) ",
"NDC11Code": "10135-0699-01",
"ProductNDC": "10135-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210653",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro- 5H-dibenz[ b,f] azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1 (25 mg and 50 mg strengths only), FD&C Red No. 3 (25 mg and 50 mg strengths only), FD&C Red No. 40 (50 mg strength only), FD&C Yellow No. 6 (25 mg and 75 mg strength only), gelatin , magnesium stearate, pregelatinized starch, and titanium dioxide. In addition, the black imprinting ink for the 25 mg, 50 mg and 75 mg capsules contains black iron oxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "16714-699-01",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16714-699-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "16714-0699-01",
"ProductNDC": "16714-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205779",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160329",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of Infection.",
"Description": "Vancomycin hydrochloride for injection, USP is a white or off-white to light tan sterile, lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "43269-699-17",
"PackageDescription": "517 mL in 1 BOTTLE, PUMP (43269-699-17)",
"NDC11Code": "43269-0699-17",
"ProductNDC": "43269-699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mulling Spices Antibacterial Foaming Hand Wash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110726",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".2",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71205-699-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (71205-699-10) ",
"NDC11Code": "71205-0699-10",
"ProductNDC": "71205-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220916",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink."
},
{
"NDCCode": "71205-699-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (71205-699-14) ",
"NDC11Code": "71205-0699-14",
"ProductNDC": "71205-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220916",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink."
},
{
"NDCCode": "71205-699-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (71205-699-20) ",
"NDC11Code": "71205-0699-20",
"ProductNDC": "71205-699",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220906",
"MarketingCategoryName": "ANDA",
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"LabelerName": "EXELAN PHARMACEUTICALS INC.",
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"IndicationAndUsage": ". Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itchy nose or throat."
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<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
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<PackageDescription>1 BOTTLE in 1 CARTON (36800-699-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0699-26</NDC11Code>
<ProductNDC>36800-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Childrens Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache , 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41226-699-26</NDCCode>
<PackageDescription>225 TABLET, EXTENDED RELEASE in 1 BOTTLE (41226-699-26) </PackageDescription>
<NDC11Code>41226-0699-26</NDC11Code>
<ProductNDC>41226-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-699-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0699-26</NDC11Code>
<ProductNDC>69842-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>30; 12.5</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</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>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. controls the impulse to cough to help you sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-929-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69842-929-12) * 1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69842-819-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0929-12</NDC11Code>
<ProductNDC>69842-929</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Dm Max Daytime Nighttime</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Doxylamine Succinate, Guaifesesin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49483-699-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) </PackageDescription>
<NDC11Code>49483-0699-01</NDC11Code>
<ProductNDC>49483-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-699-05</NDCCode>
<PackageDescription>50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>49483-0699-05</NDC11Code>
<ProductNDC>49483-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-699-40</NDCCode>
<PackageDescription>400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) </PackageDescription>
<NDC11Code>49483-0699-40</NDC11Code>
<ProductNDC>49483-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-699-42</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>49483-0699-42</NDC11Code>
<ProductNDC>49483-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10135-699-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (10135-699-01) </PackageDescription>
<NDC11Code>10135-0699-01</NDC11Code>
<ProductNDC>10135-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210653</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro- 5H-dibenz[ b,f] azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1 (25 mg and 50 mg strengths only), FD&C Red No. 3 (25 mg and 50 mg strengths only), FD&C Red No. 40 (50 mg strength only), FD&C Yellow No. 6 (25 mg and 75 mg strength only), gelatin , magnesium stearate, pregelatinized starch, and titanium dioxide. In addition, the black imprinting ink for the 25 mg, 50 mg and 75 mg capsules contains black iron oxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>16714-699-01</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16714-699-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>16714-0699-01</NDC11Code>
<ProductNDC>16714-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205779</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of Infection.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is a white or off-white to light tan sterile, lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>43269-699-17</NDCCode>
<PackageDescription>517 mL in 1 BOTTLE, PUMP (43269-699-17)</PackageDescription>
<NDC11Code>43269-0699-17</NDC11Code>
<ProductNDC>43269-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mulling Spices Antibacterial Foaming Hand Wash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71205-699-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (71205-699-10) </PackageDescription>
<NDC11Code>71205-0699-10</NDC11Code>
<ProductNDC>71205-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>71205-699-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (71205-699-14) </PackageDescription>
<NDC11Code>71205-0699-14</NDC11Code>
<ProductNDC>71205-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
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<SubstanceName>BENZONATATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
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<NDCCode>71205-699-21</NDCCode>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
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<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
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<NDC>
<NDCCode>71205-699-30</NDCCode>
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<NDC11Code>71205-0699-30</NDC11Code>
<ProductNDC>71205-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>71205-699-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-699-60) </PackageDescription>
<NDC11Code>71205-0699-60</NDC11Code>
<ProductNDC>71205-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>71205-699-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-699-90) </PackageDescription>
<NDC11Code>71205-0699-90</NDC11Code>
<ProductNDC>71205-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>71919-699-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-699-07) </PackageDescription>
<NDC11Code>71919-0699-07</NDC11Code>
<ProductNDC>71919-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ustilago Maidis</ProprietaryName>
<NonProprietaryName>Ustilago Maydis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>USTILAGO MAYDIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>71919-699-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-699-08) </PackageDescription>
<NDC11Code>71919-0699-08</NDC11Code>
<ProductNDC>71919-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ustilago Maidis</ProprietaryName>
<NonProprietaryName>Ustilago Maydis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>USTILAGO MAYDIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-699-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-699-09) </PackageDescription>
<NDC11Code>71919-0699-09</NDC11Code>
<ProductNDC>71919-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ustilago Maidis</ProprietaryName>
<NonProprietaryName>Ustilago Maydis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>USTILAGO MAYDIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-699-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-699-10) </PackageDescription>
<NDC11Code>71919-0699-10</NDC11Code>
<ProductNDC>71919-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ustilago Maidis</ProprietaryName>
<NonProprietaryName>Ustilago Maydis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>USTILAGO MAYDIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76282-699-47</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47) </PackageDescription>
<NDC11Code>76282-0699-47</NDC11Code>
<ProductNDC>76282-699</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenalidomide</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210435</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS INC.</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure. The empirical formula for lenalidomide is C13H13N3O3, and with relative molecular mass 259.26 a.m.u. Lenalidomide is an off-white to pale-yellow solid powder. It is freely soluble in dimethyl formamide and practically insoluble in water, diethyl ether, ethanol, and buffered aqueous solvents. Solubility was significantly lower in buffers, ranging from 1.2 to 6.8 as 0.01g in 100 mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, yellow iron oxide, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 15 mg capsule shell contains gelatin, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 20 mg capsule shell contains gelatin, yellow iron oxide, FD&C Blue # 2, titanium dioxide, and black ink. The imprinting ink for 5 mg, 10 mg, 15 mg and 25 mg contains black iron oxide, potassium hydroxide, propylene glycol, purified water, and shellac. The imprinting ink for 20 mg contains black iron oxide, D & C yellow # 10, FD & C blue # 1, FD & C blue # 2, FD & C red # 40, and propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>84515-699-01</NDCCode>
<PackageDescription>30 g in 1 BOX (84515-699-01) </PackageDescription>
<NDC11Code>84515-0699-01</NDC11Code>
<ProductNDC>84515-699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pramoxicilin Active Face Cream</ProprietaryName>
<NonProprietaryName>Pramoxicilin Active Face Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241023</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241023</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49483-061-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01) </PackageDescription>
<NDC11Code>49483-0061-01</NDC11Code>
<ProductNDC>49483-061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>. Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itchy nose or throat.</IndicationAndUsage>
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<IndicationAndUsage>. Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itchy nose or throat.</IndicationAndUsage>
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<IndicationAndUsage>. Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itchy nose or throat.</IndicationAndUsage>
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