{
"NDC": [
{
"NDCCode": "0065-0418-80",
"PackageDescription": "2 BOTTLE, DROPPER in 1 CARTON (0065-0418-80) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0418-80",
"ProductNDC": "0065-0418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal Tears (mild)",
"NonProprietaryName": "Dextran 70 And Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": "1; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N"
},
{
"NDCCode": "0065-1431-80",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-1431-80",
"ProductNDC": "0065-1431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Systane Ultra",
"NonProprietaryName": "Polyethylene Glycol 400 And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": "4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141001",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye . for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun."
},
{
"NDCCode": "0065-0418-15",
"PackageDescription": "15 mL in 1 BOTTLE, DROPPER (0065-0418-15)",
"NDC11Code": "00065-0418-15",
"ProductNDC": "0065-0418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tears Naturale Ii Polyquad",
"NonProprietaryName": "Dextran 70 And Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": "1; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2016-02-19"
},
{
"NDCCode": "0065-0418-81",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0418-81) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0418-81",
"ProductNDC": "0065-0418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genteal Tears (mild)",
"NonProprietaryName": "Dextran 70 And Hypromellose 2910",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)",
"StrengthNumber": "1; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N"
},
{
"NDCCode": "12634-418-80",
"PackageDescription": "20 TABLET in 1 BOTTLE (12634-418-80)",
"NDC11Code": "12634-0418-80",
"ProductNDC": "12634-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091179",
"LabelerName": "Apotheca, Inc",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake."
},
{
"NDCCode": "43744-418-80",
"PackageDescription": "20000 g in 1 DRUM (43744-418-80)",
"NDC11Code": "43744-0418-80",
"ProductNDC": "43744-418",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Flunixin Meglumine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120801",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "FLUNIXIN MEGLUMINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "10812-418-01",
"PackageDescription": "198 mL in 1 BOTTLE, PUMP (10812-418-01) ",
"NDC11Code": "10812-0418-01",
"ProductNDC": "10812-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Beach Defense Water Plus Sun Protection",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120601",
"EndMarketingDate": "20211224",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "27; 80; 50; 35; 40",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120601",
"EndMarketingDatePackage": "20211224",
"SamplePackage": "N"
},
{
"NDCCode": "35573-418-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-418-30) ",
"NDC11Code": "35573-0418-30",
"ProductNDC": "35573-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170530",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "49502-418-02",
"PackageDescription": "2 TRAY in 1 KIT (49502-418-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-482-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-483-06) / 1 mL in 1 PACKET",
"NDC11Code": "49502-0418-02",
"ProductNDC": "49502-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-fkjp",
"DosageFormName": "KIT",
"StartMarketingDate": "20230702",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761154",
"LabelerName": "Viatris Specialty LLC",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230702",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH."
},
{
"NDCCode": "61919-418-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (61919-418-60) ",
"NDC11Code": "61919-0418-60",
"ProductNDC": "61919-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077870",
"LabelerName": "DirectRX",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151203",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide USP and metformin hydrochloride USP. Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound. The structural formula is represented below. [Glyburide Chemical Structure]. Metformin hydrochloride USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown. [Metformin Chemical Structure]. Glyburide and metformin hydrochloride tablets, USP are available for oral administration containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake."
},
{
"NDCCode": "62135-418-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-418-90) ",
"NDC11Code": "62135-0418-90",
"ProductNDC": "62135-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215141",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221020",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below:. Fluphenazine Hydrochloride Tablets, USP for oral administration, contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains D&C Yellow No. 10 Al. Lake (2.5 mg and 5 mg tablets), FD&C Blue No. 1 Al. Lake (5 mg tablets), FD&C Yellow No. 6 Al. Lake (2.5 mg, 5 mg and 10 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, purified water, talc, and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "67877-418-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-418-05) ",
"NDC11Code": "67877-0418-05",
"ProductNDC": "67877-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205536",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2."
},
{
"NDCCode": "67877-418-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (67877-418-10) ",
"NDC11Code": "67877-0418-10",
"ProductNDC": "67877-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205536",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2."
},
{
"NDCCode": "67877-418-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (67877-418-90) ",
"NDC11Code": "67877-0418-90",
"ProductNDC": "67877-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205536",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2."
},
{
"NDCCode": "68645-418-54",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68645-418-54)",
"NDC11Code": "68645-0418-54",
"ProductNDC": "68645-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Legacy Pharmaceutical Packaging",
"SubstanceName": "ATORVASTATIN CALCIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "70934-418-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70934-418-30) ",
"NDC11Code": "70934-0418-30",
"ProductNDC": "70934-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190805",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190805",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"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 indicated 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.",
"Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide."
},
{
"NDCCode": "82645-418-96",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (82645-418-96) ",
"NDC11Code": "82645-0418-96",
"ProductNDC": "82645-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calamine",
"NonProprietaryName": "Calamine And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230516",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Pharma Nobis, LLC",
"SubstanceName": "FERRIC OXIDE RED; ZINC OXIDE",
"StrengthNumber": "80; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230516",
"SamplePackage": "N",
"IndicationAndUsage": "Dries the oozing and weeping of poison ivy, poison oak, and poison sumac."
},
{
"NDCCode": "0065-8000-03",
"PackageDescription": "10000 mL in 1 BOTTLE (0065-8000-03) ",
"NDC11Code": "00065-8000-03",
"ProductNDC": "0065-8000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Antiseptic 80%",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200403",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200403",
"SamplePackage": "N"
},
{
"NDCCode": "0065-8000-04",
"PackageDescription": "10000 mL in 1 BOTTLE (0065-8000-04) ",
"NDC11Code": "00065-8000-04",
"ProductNDC": "0065-8000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Antiseptic 80%",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200403",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200403",
"SamplePackage": "N"
},
{
"NDCCode": "0179-0036-80",
"PackageDescription": "10 mL in 1 CUP, UNIT-DOSE (0179-0036-80)",
"NDC11Code": "00179-0036-80",
"ProductNDC": "0179-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Re-pb Hyos Elixir",
"NonProprietaryName": "Belladonna Alkaloids W/ Phenobarbital",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20091020",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1037; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "0179-0088-80",
"PackageDescription": "10 mL in 1 CUP, UNIT-DOSE (0179-0088-80)",
"NDC11Code": "00179-0088-80",
"ProductNDC": "0179-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donnatal",
"NonProprietaryName": "Belladonna Alkaloids W/ Phenobarbital",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1037; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "27241-065-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (27241-065-06) ",
"NDC11Code": "27241-0065-06",
"ProductNDC": "27241-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206714",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: : 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) , 2 Acute Maxillary Sinusitis (1.2) , 3 Community-Acquired Pneumonia (1.3) , 4 Pharyngitis/Tonsillitis (1.4) , 5 Uncomplicated Skin and Skin Structure Infections (1.5) , 6 Acute Otitis Media in Pediatric Patients (1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) , 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8).",
"Description": "Clarithromycin, USP is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Figure 1: Structure of Clarithromycin Clarithromycin, USP is a white or almost white, crystalline powder. It is soluble in acetone; in methylene chloride, slightly soluble in dehydrated alcohol, in methanol and in acetonitrile and in phosphate buffer at pH values of 2 to 5, practically insoluble in water. Clarithromycin, USP is available as immediate-release tablets. Each yellow to light yellow colored, oval shaped, film-coated clarithromycin tablets, USP contain 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: 250 mg and 500 mg tablets: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, propylene glycol, hydroxypropyl cellulose, polysorbate 80, D&C Yellow # 10, aluminum lake, sorbic acid, vanillin, and iron oxide yellow."
},
{
"NDCCode": "33342-065-10",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (33342-065-10) ",
"NDC11Code": "33342-0065-10",
"ProductNDC": "33342-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202696",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160919",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxides (yellow, black and/or red), microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "33342-065-15",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (33342-065-15) ",
"NDC11Code": "33342-0065-15",
"ProductNDC": "33342-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202696",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160919",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxides (yellow, black and/or red), microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "41163-065-05",
"PackageDescription": "355 mL in 1 BOTTLE (41163-065-05) ",
"NDC11Code": "41163-0065-05",
"ProductNDC": "41163-065",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Antacid Cherry",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Simethicone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "UNITED NATURAL FOODS, INC. DBA UNFI",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "800; 800; 80",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "relieves."
},
{
"NDCCode": "42291-065-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-065-30) ",
"NDC11Code": "42291-0065-30",
"ProductNDC": "42291-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079022",
"LabelerName": "AvKARE",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220412",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1).",
"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "55513-065-01",
"PackageDescription": "1 VIAL in 1 CARTON (55513-065-01) / .05 mL in 1 VIAL",
"NDC11Code": "55513-0065-01",
"ProductNDC": "55513-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pavblu",
"NonProprietaryName": "Aflibercept-ayyh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761298",
"LabelerName": "Amgen, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "PAVBLU is indicated for the treatment of.",
"Description": "Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2."
},
{
"NDCCode": "55513-065-96",
"PackageDescription": "1 VIAL in 1 CARTON (55513-065-96) / .05 mL in 1 VIAL",
"NDC11Code": "55513-0065-96",
"ProductNDC": "55513-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pavblu",
"NonProprietaryName": "Aflibercept-ayyh",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761298",
"LabelerName": "Amgen, Inc",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "2",
"StrengthUnit": "mg/.05mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "PAVBLU is indicated for the treatment of.",
"Description": "Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2."
},
{
"NDCCode": "57319-065-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (57319-065-01) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "57319-0065-01",
"ProductNDC": "57319-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040069",
"LabelerName": "Phoenix Pharmaceutical, Inc.",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of the following conditions. Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.",
"Description": "Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%."
},
{
"NDCCode": "58151-065-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (58151-065-93) ",
"NDC11Code": "58151-0065-93",
"ProductNDC": "58151-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caduet",
"NonProprietaryName": "Amlodipine And Atorvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021540",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260225",
"SamplePackage": "N",
"IndicationAndUsage": "CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.",
"Description": "CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [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. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium 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. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium."
}
]
}
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<NDC>
<NDCCode>0065-0418-80</NDCCode>
<PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (0065-0418-80) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
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<ProductNDC>0065-0418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genteal Tears (mild)</ProprietaryName>
<NonProprietaryName>Dextran 70 And Hypromellose 2910</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)</SubstanceName>
<StrengthNumber>1; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>0065-1431-80</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-1431-80</NDC11Code>
<ProductNDC>0065-1431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Systane Ultra</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400 And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye . for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.</IndicationAndUsage>
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<NDC>
<NDCCode>0065-0418-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, DROPPER (0065-0418-15)</PackageDescription>
<NDC11Code>00065-0418-15</NDC11Code>
<ProductNDC>0065-0418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tears Naturale Ii Polyquad</ProprietaryName>
<NonProprietaryName>Dextran 70 And Hypromellose 2910</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19900801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)</SubstanceName>
<StrengthNumber>1; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0065-0418-81</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0418-81) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0418-81</NDC11Code>
<ProductNDC>0065-0418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genteal Tears (mild)</ProprietaryName>
<NonProprietaryName>Dextran 70 And Hypromellose 2910</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)</SubstanceName>
<StrengthNumber>1; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12634-418-80</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (12634-418-80)</PackageDescription>
<NDC11Code>12634-0418-80</NDC11Code>
<ProductNDC>12634-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091179</ApplicationNumber>
<LabelerName>Apotheca, Inc</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake.</Description>
</NDC>
<NDC>
<NDCCode>43744-418-80</NDCCode>
<PackageDescription>20000 g in 1 DRUM (43744-418-80)</PackageDescription>
<NDC11Code>43744-0418-80</NDC11Code>
<ProductNDC>43744-418</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Flunixin Meglumine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120801</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>FLUNIXIN MEGLUMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10812-418-01</NDCCode>
<PackageDescription>198 mL in 1 BOTTLE, PUMP (10812-418-01) </PackageDescription>
<NDC11Code>10812-0418-01</NDC11Code>
<ProductNDC>10812-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Beach Defense Water Plus Sun Protection</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<EndMarketingDate>20211224</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>27; 80; 50; 35; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<EndMarketingDatePackage>20211224</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>35573-418-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (35573-418-30) </PackageDescription>
<NDC11Code>35573-0418-30</NDC11Code>
<ProductNDC>35573-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>49502-418-02</NDCCode>
<PackageDescription>2 TRAY in 1 KIT (49502-418-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-482-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-483-06) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>49502-0418-02</NDC11Code>
<ProductNDC>49502-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-fkjp</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230702</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761154</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients., 7 Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 8 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 9 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 10 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-fkjp is a tumor necrosis factor blocker. Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody. Adalimumab-fkjp is produced by recombinant DNA technology in a mammalian cell expression system (Chinese Hamster Ovary Cells) and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-fkjp is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-fkjp Pen) or as a single-dose, 1 mL prefilled plastic syringe. Enclosed within the pen is a single- dose, 1 mL prefilled plastic syringe. The solution of Adalimumab-fkjp is clear to slightly opalescent, colorless to pale brownish-yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-fkjp contains adalimumab-fkjp (40 mg), methionine (0.60 mg), monosodium glutamate (1.50 mg), polysorbate 80 (0.80 mg), sorbitol (38.2 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-fkjp contains adalimumab-fkjp (20 mg), methionine (0.30 mg), monosodium glutamate (0.75 mg), polysorbate 80 (0.40 mg), sorbitol (19.1 mg) and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-418-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (61919-418-60) </PackageDescription>
<NDC11Code>61919-0418-60</NDC11Code>
<ProductNDC>61919-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077870</ApplicationNumber>
<LabelerName>DirectRX</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide USP and metformin hydrochloride USP. Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound. The structural formula is represented below. [Glyburide Chemical Structure]. Metformin hydrochloride USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown. [Metformin Chemical Structure]. Glyburide and metformin hydrochloride tablets, USP are available for oral administration containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>62135-418-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-418-90) </PackageDescription>
<NDC11Code>62135-0418-90</NDC11Code>
<ProductNDC>62135-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215141</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below:. Fluphenazine Hydrochloride Tablets, USP for oral administration, contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains D&C Yellow No. 10 Al. Lake (2.5 mg and 5 mg tablets), FD&C Blue No. 1 Al. Lake (5 mg tablets), FD&C Yellow No. 6 Al. Lake (2.5 mg, 5 mg and 10 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, purified water, talc, and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>67877-418-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-418-05) </PackageDescription>
<NDC11Code>67877-0418-05</NDC11Code>
<ProductNDC>67877-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205536</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>67877-418-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (67877-418-10) </PackageDescription>
<NDC11Code>67877-0418-10</NDC11Code>
<ProductNDC>67877-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205536</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>67877-418-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (67877-418-90) </PackageDescription>
<NDC11Code>67877-0418-90</NDC11Code>
<ProductNDC>67877-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205536</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68645-418-54</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68645-418-54)</PackageDescription>
<NDC11Code>68645-0418-54</NDC11Code>
<ProductNDC>68645-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Legacy Pharmaceutical Packaging</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>70934-418-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70934-418-30) </PackageDescription>
<NDC11Code>70934-0418-30</NDC11Code>
<ProductNDC>70934-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190805</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190805</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 indicated 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.</IndicationAndUsage>
<Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide.</Description>
</NDC>
<NDC>
<NDCCode>82645-418-96</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (82645-418-96) </PackageDescription>
<NDC11Code>82645-0418-96</NDC11Code>
<ProductNDC>82645-418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calamine</ProprietaryName>
<NonProprietaryName>Calamine And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Pharma Nobis, LLC</LabelerName>
<SubstanceName>FERRIC OXIDE RED; ZINC OXIDE</SubstanceName>
<StrengthNumber>80; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-8000-03</NDCCode>
<PackageDescription>10000 mL in 1 BOTTLE (0065-8000-03) </PackageDescription>
<NDC11Code>00065-8000-03</NDC11Code>
<ProductNDC>0065-8000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Antiseptic 80%</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-8000-04</NDCCode>
<PackageDescription>10000 mL in 1 BOTTLE (0065-8000-04) </PackageDescription>
<NDC11Code>00065-8000-04</NDC11Code>
<ProductNDC>0065-8000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Antiseptic 80%</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0179-0036-80</NDCCode>
<PackageDescription>10 mL in 1 CUP, UNIT-DOSE (0179-0036-80)</PackageDescription>
<NDC11Code>00179-0036-80</NDC11Code>
<ProductNDC>0179-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Re-pb Hyos Elixir</ProprietaryName>
<NonProprietaryName>Belladonna Alkaloids W/ Phenobarbital</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>0179-0088-80</NDCCode>
<PackageDescription>10 mL in 1 CUP, UNIT-DOSE (0179-0088-80)</PackageDescription>
<NDC11Code>00179-0088-80</NDC11Code>
<ProductNDC>0179-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donnatal</ProprietaryName>
<NonProprietaryName>Belladonna Alkaloids W/ Phenobarbital</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>27241-065-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (27241-065-06) </PackageDescription>
<NDC11Code>27241-0065-06</NDC11Code>
<ProductNDC>27241-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206714</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: : 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) , 2 Acute Maxillary Sinusitis (1.2) , 3 Community-Acquired Pneumonia (1.3) , 4 Pharyngitis/Tonsillitis (1.4) , 5 Uncomplicated Skin and Skin Structure Infections (1.5) , 6 Acute Otitis Media in Pediatric Patients (1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) , 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8).</IndicationAndUsage>
<Description>Clarithromycin, USP is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Figure 1: Structure of Clarithromycin Clarithromycin, USP is a white or almost white, crystalline powder. It is soluble in acetone; in methylene chloride, slightly soluble in dehydrated alcohol, in methanol and in acetonitrile and in phosphate buffer at pH values of 2 to 5, practically insoluble in water. Clarithromycin, USP is available as immediate-release tablets. Each yellow to light yellow colored, oval shaped, film-coated clarithromycin tablets, USP contain 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: 250 mg and 500 mg tablets: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, propylene glycol, hydroxypropyl cellulose, polysorbate 80, D&C Yellow # 10, aluminum lake, sorbic acid, vanillin, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>33342-065-10</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-065-10) </PackageDescription>
<NDC11Code>33342-0065-10</NDC11Code>
<ProductNDC>33342-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202696</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxides (yellow, black and/or red), microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>33342-065-15</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (33342-065-15) </PackageDescription>
<NDC11Code>33342-0065-15</NDC11Code>
<ProductNDC>33342-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202696</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, iron oxides (yellow, black and/or red), microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>41163-065-05</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (41163-065-05) </PackageDescription>
<NDC11Code>41163-0065-05</NDC11Code>
<ProductNDC>41163-065</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Antacid Cherry</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Simethicone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>UNITED NATURAL FOODS, INC. DBA UNFI</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>800; 800; 80</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-065-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-065-30) </PackageDescription>
<NDC11Code>42291-0065-30</NDC11Code>
<ProductNDC>42291-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079022</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1).</IndicationAndUsage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>55513-065-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (55513-065-01) / .05 mL in 1 VIAL</PackageDescription>
<NDC11Code>55513-0065-01</NDC11Code>
<ProductNDC>55513-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pavblu</ProprietaryName>
<NonProprietaryName>Aflibercept-ayyh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761298</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PAVBLU is indicated for the treatment of.</IndicationAndUsage>
<Description>Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-065-96</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (55513-065-96) / .05 mL in 1 VIAL</PackageDescription>
<NDC11Code>55513-0065-96</NDC11Code>
<ProductNDC>55513-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pavblu</ProprietaryName>
<NonProprietaryName>Aflibercept-ayyh</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761298</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PAVBLU is indicated for the treatment of.</IndicationAndUsage>
<Description>Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept-ayyh is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept-ayyh is produced in recombinant Chinese hamster ovary (CHO) cells. PAVBLU (aflibercept-ayyh) injection is a sterile, clear to opalescent and colorless to slightly yellow solution. PAVBLU does not contain anti-microbial preservative and is supplied as an aqueous solution for intravitreal injection in a single-dose prefilled plastic syringe or a single-dose glass vial designed to deliver 0.05 mL (50 microliters) of solution containing 2 mg of aflibercept-ayyh in polysorbate 80 (0.005 mg), sucrose (2.5 mg), trehalose (1.58 mg) and water for injection with a pH of 6.2.</Description>
</NDC>
<NDC>
<NDCCode>57319-065-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (57319-065-01) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>57319-0065-01</NDC11Code>
<ProductNDC>57319-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040069</ApplicationNumber>
<LabelerName>Phoenix Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of the following conditions. Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula. C22H28FNa2O8P. Mol. wt. 516.41. Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble at 25°C than hydrocortisone. Each mL Contains: ACTIVE: Dexamethasone Sodium Phosphate, [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. INACTIVES: Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6 - 7.8). PRESERVATIVES ADDED: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%.</Description>
</NDC>
<NDC>
<NDCCode>58151-065-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58151-065-93) </PackageDescription>
<NDC11Code>58151-0065-93</NDC11Code>
<ProductNDC>58151-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caduet</ProprietaryName>
<NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021540</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
<Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S. Atorvastatin calcium is chemically described as [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. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium 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. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
</NDC>
</NDCList>