{
"NDC": [
{
"NDCCode": "50268-280-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-280-15) / 1 CAPSULE in 1 BLISTER PACK (50268-280-11) ",
"NDC11Code": "50268-0280-15",
"ProductNDC": "50268-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205115",
"LabelerName": "AvPAK",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, 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. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
"Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C 22H 24N 2O 8 H 2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2."
},
{
"NDCCode": "21695-280-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (21695-280-15)",
"NDC11Code": "21695-0280-15",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "24208-280-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-280-15) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0280-15",
"ProductNDC": "24208-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Murocel",
"NonProprietaryName": "Methylcellulose",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110504",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "METHYLCELLULOSE (4000 CPS)",
"StrengthNumber": "10",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "43353-280-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (43353-280-15)",
"NDC11Code": "43353-0280-15",
"ProductNDC": "43353-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091624",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium tablets is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide."
},
{
"NDCCode": "49035-280-01",
"PackageDescription": "2 BOTTLE, DROPPER in 1 BOX (49035-280-01) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "49035-0280-01",
"ProductNDC": "49035-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Eye Drops Dry Eye Relief",
"NonProprietaryName": "Glycerin, Hypromellose, Polyethylene Glycol 400",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400",
"StrengthNumber": ".2; .2; 1",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "for protection against further irritation. for temporary relief of burning and irritation due to dryness of the eye."
},
{
"NDCCode": "49035-280-02",
"PackageDescription": "2 BOTTLE, DROPPER in 1 BOX (49035-280-02) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "49035-0280-02",
"ProductNDC": "49035-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Eye Drops Dry Eye Relief",
"NonProprietaryName": "Glycerin, Hypromellose, Polyethylene Glycol 400",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400",
"StrengthNumber": ".2; .2; 1",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "for protection against further irritation. for temporary relief of burning and irritation due to dryness of the eye."
},
{
"NDCCode": "50222-280-91",
"PackageDescription": "1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE",
"NDC11Code": "50222-0280-91",
"ProductNDC": "50222-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzupgo",
"NonProprietaryName": "Delgocitinib",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219155",
"LabelerName": "LEO Pharma, Inc",
"SubstanceName": "DELGOCITINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "Y",
"IndicationAndUsage": "ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.",
"Description": "ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water."
},
{
"NDCCode": "63307-280-15",
"PackageDescription": "100 g in 1 BOTTLE (63307-280-15)",
"NDC11Code": "63307-0280-15",
"ProductNDC": "63307-280",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Total Pharmacy Supply, Inc.",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67046-280-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-15) ",
"NDC11Code": "67046-0280-15",
"ProductNDC": "67046-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "71919-280-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-280-07) ",
"NDC11Code": "71919-0280-07",
"ProductNDC": "71919-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Euphorbia Pilulifera",
"NonProprietaryName": "Euphorbia Hirta Flowering Top",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "EUPHORBIA HIRTA FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121129",
"SamplePackage": "N"
},
{
"NDCCode": "72189-280-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (72189-280-15) ",
"NDC11Code": "72189-0280-15",
"ProductNDC": "72189-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "DirectRx",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211007",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Image Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide."
},
{
"NDCCode": "73962-002-15",
"PackageDescription": "280 mL in 1 BOTTLE, PUMP (73962-002-15) ",
"NDC11Code": "73962-0002-15",
"ProductNDC": "73962-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang USHAS Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "73962-004-15",
"PackageDescription": "280 mL in 1 BOTTLE, PUMP (73962-004-15) ",
"NDC11Code": "73962-0004-15",
"ProductNDC": "73962-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "75%",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang USHAS Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "74092-280-15",
"PackageDescription": "1 BAG in 1 BOX (74092-280-15) > 3 L in 1 BAG (74092-280-14) ",
"NDC11Code": "74092-0280-15",
"ProductNDC": "74092-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol Antiseptic 80% Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200402",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Caribbean Distillers LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "8000",
"StrengthUnit": "L/10000L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75936-280-03",
"PackageDescription": "15 mL in 1 TUBE (75936-280-03) ",
"NDC11Code": "75936-0280-03",
"ProductNDC": "75936-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Mattescreen Broad Spectrum Spf 40",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Taylor James",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".7; 17",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N"
},
{
"NDCCode": "82153-280-00",
"PackageDescription": "1 KIT in 1 KIT (82153-280-00) * 1 TUBE in 1 CARTON (82153-281-00) / 15 mL in 1 TUBE",
"NDC11Code": "82153-0280-00",
"ProductNDC": "82153-280",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Live Tinted Glow-up Hyperpigmentation Essentials",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Live Tinted, Inc.",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50268-033-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-033-15) / 1 TABLET in 1 BLISTER PACK (50268-033-11) ",
"NDC11Code": "50268-0033-15",
"ProductNDC": "50268-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "AvPAK",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250925",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
},
{
"NDCCode": "50268-034-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-034-15) / 1 TABLET in 1 BLISTER PACK (50268-034-11) ",
"NDC11Code": "50268-0034-15",
"ProductNDC": "50268-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "AvPAK",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
},
{
"NDCCode": "50268-035-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-035-15) / 1 TABLET in 1 BLISTER PACK (50268-035-11) ",
"NDC11Code": "50268-0035-15",
"ProductNDC": "50268-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "AvPAK",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
},
{
"NDCCode": "50268-037-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-037-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-037-11) ",
"NDC11Code": "50268-0037-15",
"ProductNDC": "50268-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "AvPAK",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "50268-038-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-038-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-038-11) ",
"NDC11Code": "50268-0038-15",
"ProductNDC": "50268-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "AvPAK",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "50268-039-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-039-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-039-11) ",
"NDC11Code": "50268-0039-15",
"ProductNDC": "50268-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "AvPAK",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "50268-040-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-040-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-040-11) ",
"NDC11Code": "50268-0040-15",
"ProductNDC": "50268-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "AvPAK",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "50268-041-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11) ",
"NDC11Code": "50268-0041-15",
"ProductNDC": "50268-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "AvPAK",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "50268-043-15",
"PackageDescription": "15 mL in 1 BOTTLE (50268-043-15) ",
"NDC11Code": "50268-0043-15",
"ProductNDC": "50268-043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Artificial Tears",
"NonProprietaryName": "Artificial Tears",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "AvPAK",
"SubstanceName": "DEXTRAN 70; GLYCERIN; HYPROMELLOSES",
"StrengthNumber": "1; 2; 3",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation."
},
{
"NDCCode": "50268-050-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11) ",
"NDC11Code": "50268-0050-15",
"ProductNDC": "50268-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvPAK",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100916",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Acebutolol HCl capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Ventricular Arrhythmias Acebutolol HCl capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.",
"Description": "Acebutolol HCl, USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol HCl capsules, USP are provided in two dosage strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, maize starch, povidone, stearic acid and titanium dioxide. Acebutolol HCl, USP has the following structural formula. C 18H 28N 2O 4HCl M.W. 372.89. Acebutolol HCl, USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl] butanamide."
},
{
"NDCCode": "50268-051-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-051-15) > 1 CAPSULE in 1 BLISTER PACK (50268-051-11)",
"NDC11Code": "50268-0051-15",
"ProductNDC": "50268-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvPAK",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50268-052-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-052-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-052-11) ",
"NDC11Code": "50268-0052-15",
"ProductNDC": "50268-052",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Reliever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076200",
"LabelerName": "AvPAK",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160307",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. premenstrual and menstrual cramps. the common cold. headache. toothache. temporarily reduces fever."
},
{
"NDCCode": "50268-053-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-053-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-053-11) ",
"NDC11Code": "50268-0053-15",
"ProductNDC": "50268-053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Pain Relief",
"NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "AvPAK",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160823",
"SamplePackage": "N"
},
{
"NDCCode": "50268-054-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-054-15) / 1 TABLET in 1 BLISTER PACK (50268-054-11) ",
"NDC11Code": "50268-0054-15",
"ProductNDC": "50268-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209734",
"LabelerName": "AvPAK",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200707",
"SamplePackage": "N",
"IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
"Description": "Acetazolamide an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, very slightly soluble in water, sparingly soluble in practically boiling water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure:. Molecular Weight: 222.25. Molecular Formula: C 4H 6N 4O 3S 2. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: corn starch, gelatin, glycerin, lactose monohydrate, magnesium stearate, purified water, sodium starch glycolate (Potato) and talc."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50268-280-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-280-15) / 1 CAPSULE in 1 BLISTER PACK (50268-280-11) </PackageDescription>
<NDC11Code>50268-0280-15</NDC11Code>
<ProductNDC>50268-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205115</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, 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. Doxycycline capsules, USP are indicated for the treatment of the following infections. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline capsules, USP are also indicated for the treatment of infections caused by the following gram-negative microorganisms:. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline capsules, USP are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C 22H 24N 2O 8 H 2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (21695-280-15)</PackageDescription>
<NDC11Code>21695-0280-15</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>24208-280-15</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-280-15) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0280-15</NDC11Code>
<ProductNDC>24208-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Murocel</ProprietaryName>
<NonProprietaryName>Methylcellulose</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110504</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>METHYLCELLULOSE (4000 CPS)</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-280-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (43353-280-15)</PackageDescription>
<NDC11Code>43353-0280-15</NDC11Code>
<ProductNDC>43353-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091624</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium tablets is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49035-280-01</NDCCode>
<PackageDescription>2 BOTTLE, DROPPER in 1 BOX (49035-280-01) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>49035-0280-01</NDC11Code>
<ProductNDC>49035-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Eye Drops Dry Eye Relief</ProprietaryName>
<NonProprietaryName>Glycerin, Hypromellose, Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400</SubstanceName>
<StrengthNumber>.2; .2; 1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for protection against further irritation. for temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-280-02</NDCCode>
<PackageDescription>2 BOTTLE, DROPPER in 1 BOX (49035-280-02) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>49035-0280-02</NDC11Code>
<ProductNDC>49035-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Eye Drops Dry Eye Relief</ProprietaryName>
<NonProprietaryName>Glycerin, Hypromellose, Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400</SubstanceName>
<StrengthNumber>.2; .2; 1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for protection against further irritation. for temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50222-280-91</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50222-0280-91</NDC11Code>
<ProductNDC>50222-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzupgo</ProprietaryName>
<NonProprietaryName>Delgocitinib</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219155</ApplicationNumber>
<LabelerName>LEO Pharma, Inc</LabelerName>
<SubstanceName>DELGOCITINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.</IndicationAndUsage>
<Description>ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient. Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5. Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile. The molecular formula is C16H18N6O and the molecular weight is 310.35 g/mol. Delgocitinib has the structural formula. Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>63307-280-15</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (63307-280-15)</PackageDescription>
<NDC11Code>63307-0280-15</NDC11Code>
<ProductNDC>63307-280</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Total Pharmacy Supply, Inc.</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67046-280-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (67046-280-15) </PackageDescription>
<NDC11Code>67046-0280-15</NDC11Code>
<ProductNDC>67046-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-280-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-280-07) </PackageDescription>
<NDC11Code>71919-0280-07</NDC11Code>
<ProductNDC>71919-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Euphorbia Pilulifera</ProprietaryName>
<NonProprietaryName>Euphorbia Hirta Flowering Top</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>EUPHORBIA HIRTA FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72189-280-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (72189-280-15) </PackageDescription>
<NDC11Code>72189-0280-15</NDC11Code>
<ProductNDC>72189-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213324</ApplicationNumber>
<LabelerName>DirectRx</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Image Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>73962-002-15</NDCCode>
<PackageDescription>280 mL in 1 BOTTLE, PUMP (73962-002-15) </PackageDescription>
<NDC11Code>73962-0002-15</NDC11Code>
<ProductNDC>73962-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang USHAS Cosmetics Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73962-004-15</NDCCode>
<PackageDescription>280 mL in 1 BOTTLE, PUMP (73962-004-15) </PackageDescription>
<NDC11Code>73962-0004-15</NDC11Code>
<ProductNDC>73962-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>75%</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang USHAS Cosmetics Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74092-280-15</NDCCode>
<PackageDescription>1 BAG in 1 BOX (74092-280-15) > 3 L in 1 BAG (74092-280-14) </PackageDescription>
<NDC11Code>74092-0280-15</NDC11Code>
<ProductNDC>74092-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol Antiseptic 80% Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Caribbean Distillers LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>8000</StrengthNumber>
<StrengthUnit>L/10000L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75936-280-03</NDCCode>
<PackageDescription>15 mL in 1 TUBE (75936-280-03) </PackageDescription>
<NDC11Code>75936-0280-03</NDC11Code>
<ProductNDC>75936-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Mattescreen Broad Spectrum Spf 40</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Taylor James</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.7; 17</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82153-280-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (82153-280-00) * 1 TUBE in 1 CARTON (82153-281-00) / 15 mL in 1 TUBE</PackageDescription>
<NDC11Code>82153-0280-00</NDC11Code>
<ProductNDC>82153-280</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Live Tinted Glow-up Hyperpigmentation Essentials</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Live Tinted, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50268-033-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-033-15) / 1 TABLET in 1 BLISTER PACK (50268-033-11) </PackageDescription>
<NDC11Code>50268-0033-15</NDC11Code>
<ProductNDC>50268-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-034-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-034-15) / 1 TABLET in 1 BLISTER PACK (50268-034-11) </PackageDescription>
<NDC11Code>50268-0034-15</NDC11Code>
<ProductNDC>50268-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-035-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-035-15) / 1 TABLET in 1 BLISTER PACK (50268-035-11) </PackageDescription>
<NDC11Code>50268-0035-15</NDC11Code>
<ProductNDC>50268-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-037-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-037-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-037-11) </PackageDescription>
<NDC11Code>50268-0037-15</NDC11Code>
<ProductNDC>50268-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-038-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-038-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-038-11) </PackageDescription>
<NDC11Code>50268-0038-15</NDC11Code>
<ProductNDC>50268-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-039-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-039-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-039-11) </PackageDescription>
<NDC11Code>50268-0039-15</NDC11Code>
<ProductNDC>50268-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-040-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-040-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-040-11) </PackageDescription>
<NDC11Code>50268-0040-15</NDC11Code>
<ProductNDC>50268-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-041-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11) </PackageDescription>
<NDC11Code>50268-0041-15</NDC11Code>
<ProductNDC>50268-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50268-043-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (50268-043-15) </PackageDescription>
<NDC11Code>50268-0043-15</NDC11Code>
<ProductNDC>50268-043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Artificial Tears</ProprietaryName>
<NonProprietaryName>Artificial Tears</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>DEXTRAN 70; GLYCERIN; HYPROMELLOSES</SubstanceName>
<StrengthNumber>1; 2; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50268-050-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11) </PackageDescription>
<NDC11Code>50268-0050-15</NDC11Code>
<ProductNDC>50268-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension Acebutolol HCl capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Ventricular Arrhythmias Acebutolol HCl capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.</IndicationAndUsage>
<Description>Acebutolol HCl, USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol HCl capsules, USP are provided in two dosage strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, maize starch, povidone, stearic acid and titanium dioxide. Acebutolol HCl, USP has the following structural formula. C 18H 28N 2O 4HCl M.W. 372.89. Acebutolol HCl, USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl] butanamide.</Description>
</NDC>
<NDC>
<NDCCode>50268-051-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-051-15) > 1 CAPSULE in 1 BLISTER PACK (50268-051-11)</PackageDescription>
<NDC11Code>50268-0051-15</NDC11Code>
<ProductNDC>50268-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50268-052-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-052-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-052-11) </PackageDescription>
<NDC11Code>50268-0052-15</NDC11Code>
<ProductNDC>50268-052</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076200</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. premenstrual and menstrual cramps. the common cold. headache. toothache. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50268-053-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-053-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-053-11) </PackageDescription>
<NDC11Code>50268-0053-15</NDC11Code>
<ProductNDC>50268-053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160823</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50268-054-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-054-15) / 1 TABLET in 1 BLISTER PACK (50268-054-11) </PackageDescription>
<NDC11Code>50268-0054-15</NDC11Code>
<ProductNDC>50268-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209734</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
<Description>Acetazolamide an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, very slightly soluble in water, sparingly soluble in practically boiling water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure:. Molecular Weight: 222.25. Molecular Formula: C 4H 6N 4O 3S 2. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: corn starch, gelatin, glycerin, lactose monohydrate, magnesium stearate, purified water, sodium starch glycolate (Potato) and talc.</Description>
</NDC>
</NDCList>