{
"NDC": [
{
"NDCCode": "43598-719-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43598-719-10) ",
"NDC11Code": "43598-0719-10",
"ProductNDC": "43598-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210742",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.",
"Description": "Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, Sodium Starch glycolate type-A, talc."
},
{
"NDCCode": "43598-719-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (43598-719-01) ",
"NDC11Code": "43598-0719-01",
"ProductNDC": "43598-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210742",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.",
"Description": "Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, Sodium Starch glycolate type-A, talc."
},
{
"NDCCode": "10135-719-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (10135-719-20) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "10135-0719-20",
"ProductNDC": "10135-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate",
"NonProprietaryName": "Alendronate Sodium Tablet",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090258",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for. : 1 Treatment and prevention of osteoporosis in postmenopausal women ( 1.1, 1.2) , 2 Treatment to increase bone mass in men with osteoporosis ( 1.3) , 3 Treatment of glucocorticoid-induced osteoporosis ( 1.4) , 4 Treatment of Paget's disease of bone ( 1.5) .",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The molecular formula of alendronate sodium is C 4H 12NNaO 7P 23H 2O and its formula weight is. 325.12. The structural formula is. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP for oral administration contain 6.53, 13.06, 45.69, or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5 mg, 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, Croscarmellose sodium, and magnesium stearate."
},
{
"NDCCode": "13811-719-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13811-719-10) ",
"NDC11Code": "13811-0719-10",
"ProductNDC": "13811-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"NonProprietaryName": "Nitrofurantoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208516",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2023-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals) is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl] methylene] amino]-2, 4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl] methylene] amino]-2, 4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-719-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-719-10) ",
"NDC11Code": "16571-0719-10",
"ProductNDC": "16571-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091388",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "41226-719-06",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (41226-719-06) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "41226-0719-06",
"ProductNDC": "41226-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Original Strength Heartburn Prevention",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230505",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "49281-719-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (49281-719-10) > .5 mL in 1 SYRINGE (49281-719-88) ",
"NDC11Code": "49281-0719-10",
"ProductNDC": "49281-719",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flublok Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125285",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN",
"StrengthNumber": "45; 45; 45; 45",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N"
},
{
"NDCCode": "50594-719-10",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (50594-719-10) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "50594-0719-10",
"ProductNDC": "50594-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sound Body Nasal",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190320",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Big Lots Stores, Inc.",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190320",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely."
},
{
"NDCCode": "55289-719-10",
"PackageDescription": "10 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-10) ",
"NDC11Code": "55289-0719-10",
"ProductNDC": "55289-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076003",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140715",
"SamplePackage": "N"
},
{
"NDCCode": "59923-719-10",
"PackageDescription": "10 AMPULE in 1 CARTON (59923-719-10) > 10 mL in 1 AMPULE",
"NDC11Code": "59923-0719-10",
"ProductNDC": "59923-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20190712",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Areva Pharmaceuticals",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190712",
"SamplePackage": "N"
},
{
"NDCCode": "63868-719-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (63868-719-20) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63868-0719-20",
"ProductNDC": "63868-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Cold Flu And Sore Throat",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130924",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130924",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "66220-719-30",
"PackageDescription": "30 POUCH in 1 CARTON (66220-719-30) > 10 g in 1 POUCH (66220-719-01) ",
"NDC11Code": "66220-0719-30",
"ProductNDC": "66220-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kristalose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074712",
"LabelerName": "Cumberland Pharmaceuticals Inc.",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/10g",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120120",
"SamplePackage": "N",
"IndicationAndUsage": "KRISTALOSE® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "KRISTALOSE (lactulose) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular formula is C12H22O11. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "67414-719-30",
"PackageDescription": "30 POUCH in 1 CARTON (67414-719-30) > 10 g in 1 POUCH (67414-719-01) ",
"NDC11Code": "67414-0719-30",
"ProductNDC": "67414-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kristalose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074712",
"LabelerName": "Jones Contract Packaging Services",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/10g",
"Pharm_Classes": "Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180124",
"SamplePackage": "N"
},
{
"NDCCode": "67877-719-31",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (67877-719-31) / 10 TABLET in 1 BLISTER PACK (67877-719-33) ",
"NDC11Code": "67877-0719-31",
"ProductNDC": "67877-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214138",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211127",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk (1.3) Recipients of transplanted organs other than kidney or liver (1.3, 5.7) Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R) 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36 dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "68016-719-20",
"PackageDescription": "2 CARTON in 1 BLISTER PACK (68016-719-20) > 10 CAPSULE in 1 CARTON",
"NDC11Code": "68016-0719-20",
"ProductNDC": "68016-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu Relief Plus",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150923",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Chain Drug Consortium, LCC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71205-719-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71205-719-10) ",
"NDC11Code": "71205-0719-10",
"ProductNDC": "71205-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221116",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
"Description": "Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. Tablets - Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium."
},
{
"NDCCode": "71288-719-11",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-10) ",
"NDC11Code": "71288-0719-11",
"ProductNDC": "71288-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20211019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214514",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211019",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4·2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl]-, dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, crystalline powder, very soluble in water. It has the following structural formula. Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) multi-dose fliptop vials contains: 20 mg of succinylcholine chloride anhydrous (equivalent to 22 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben, NF and 0.2 mg of propylparaben, NF as preservatives, 4.7 mg of sodium chloride, USP as iso-osmotic agent, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters in water for injection, USP. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "71288-719-92",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-91) ",
"NDC11Code": "71288-0719-92",
"ProductNDC": "71288-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20211019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214514",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211019",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4·2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl]-, dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, crystalline powder, very soluble in water. It has the following structural formula. Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) multi-dose fliptop vials contains: 20 mg of succinylcholine chloride anhydrous (equivalent to 22 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben, NF and 0.2 mg of propylparaben, NF as preservatives, 4.7 mg of sodium chloride, USP as iso-osmotic agent, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters in water for injection, USP. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "71919-719-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-719-10) ",
"NDC11Code": "71919-0719-10",
"ProductNDC": "71919-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wyethia Helenioides",
"NonProprietaryName": "Wyethia Helenioides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "76420-719-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-719-10) ",
"NDC11Code": "76420-0719-10",
"ProductNDC": "76420-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "43598-001-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) ",
"NDC11Code": "43598-0001-10",
"ProductNDC": "43598-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-10",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) ",
"NDC11Code": "43598-0002-10",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-008-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) ",
"NDC11Code": "43598-0008-10",
"ProductNDC": "43598-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-009-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) ",
"NDC11Code": "43598-0009-10",
"ProductNDC": "43598-009",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-027-48",
"PackageDescription": "1 KIT in 1 CARTON (43598-027-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-029-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-028-35) ",
"NDC11Code": "43598-0027-48",
"ProductNDC": "43598-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203655",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"Status": "Deprecated",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210426",
"SamplePackage": "N",
"IndicationAndUsage": "Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
"Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously."
},
{
"NDCCode": "43598-032-37",
"PackageDescription": "10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "43598-0032-37",
"ProductNDC": "43598-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20261005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215820",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261005",
"SamplePackage": "N",
"Description": "Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0."
},
{
"NDCCode": "43598-053-11",
"PackageDescription": "1 VIAL in 1 CARTON (43598-053-11) > 10 mL in 1 VIAL",
"NDC11Code": "43598-0053-11",
"ProductNDC": "43598-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215961",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2022-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220912",
"SamplePackage": "N",
"Description": "Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "43598-078-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) ",
"NDC11Code": "43598-0078-58",
"ProductNDC": "43598-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalaprilat",
"NonProprietaryName": "Enalaprilat",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075578",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ENALAPRILAT",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).",
"Description": "Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative."
},
{
"NDCCode": "43598-086-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0086-58",
"ProductNDC": "43598-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"ProprietaryNameSuffix": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218753",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).",
"Description": "Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3."
},
{
"NDCCode": "43598-087-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58) / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) ",
"NDC11Code": "43598-0087-58",
"ProductNDC": "43598-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217718",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43598-719-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43598-719-10) </PackageDescription>
<NDC11Code>43598-0719-10</NDC11Code>
<ProductNDC>43598-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210742</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, Sodium Starch glycolate type-A, talc.</Description>
</NDC>
<NDC>
<NDCCode>43598-719-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43598-719-01) </PackageDescription>
<NDC11Code>43598-0719-01</NDC11Code>
<ProductNDC>43598-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210742</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, Sodium Starch glycolate type-A, talc.</Description>
</NDC>
<NDC>
<NDCCode>10135-719-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (10135-719-20) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>10135-0719-20</NDC11Code>
<ProductNDC>10135-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate</ProprietaryName>
<NonProprietaryName>Alendronate Sodium Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090258</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for. : 1 Treatment and prevention of osteoporosis in postmenopausal women ( 1.1, 1.2) , 2 Treatment to increase bone mass in men with osteoporosis ( 1.3) , 3 Treatment of glucocorticoid-induced osteoporosis ( 1.4) , 4 Treatment of Paget's disease of bone ( 1.5) .</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The molecular formula of alendronate sodium is C 4H 12NNaO 7P 23H 2O and its formula weight is. 325.12. The structural formula is. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP for oral administration contain 6.53, 13.06, 45.69, or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5 mg, 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, Croscarmellose sodium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>13811-719-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13811-719-10) </PackageDescription>
<NDC11Code>13811-0719-10</NDC11Code>
<ProductNDC>13811-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208516</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals) is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl] methylene] amino]-2, 4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl] methylene] amino]-2, 4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-719-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16571-719-10) </PackageDescription>
<NDC11Code>16571-0719-10</NDC11Code>
<ProductNDC>16571-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091388</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>41226-719-06</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (41226-719-06) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41226-0719-06</NDC11Code>
<ProductNDC>41226-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Original Strength Heartburn Prevention</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49281-719-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (49281-719-10) > .5 mL in 1 SYRINGE (49281-719-88) </PackageDescription>
<NDC11Code>49281-0719-10</NDC11Code>
<ProductNDC>49281-719</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flublok Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/brisbane/02/2018 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/kansas/14/2017 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125285</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
<StrengthNumber>45; 45; 45; 45</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50594-719-10</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (50594-719-10) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>50594-0719-10</NDC11Code>
<ProductNDC>50594-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sound Body Nasal</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190320</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Big Lots Stores, Inc.</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-719-10</NDCCode>
<PackageDescription>10 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-10) </PackageDescription>
<NDC11Code>55289-0719-10</NDC11Code>
<ProductNDC>55289-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076003</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59923-719-10</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (59923-719-10) > 10 mL in 1 AMPULE</PackageDescription>
<NDC11Code>59923-0719-10</NDC11Code>
<ProductNDC>59923-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20190712</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Areva Pharmaceuticals</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63868-719-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (63868-719-20) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63868-0719-20</NDC11Code>
<ProductNDC>63868-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Cold Flu And Sore Throat</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130924</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130924</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66220-719-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (66220-719-30) > 10 g in 1 POUCH (66220-719-01) </PackageDescription>
<NDC11Code>66220-0719-30</NDC11Code>
<ProductNDC>66220-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kristalose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074712</ApplicationNumber>
<LabelerName>Cumberland Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KRISTALOSE® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>KRISTALOSE (lactulose) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular formula is C12H22O11. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>67414-719-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (67414-719-30) > 10 g in 1 POUCH (67414-719-01) </PackageDescription>
<NDC11Code>67414-0719-30</NDC11Code>
<ProductNDC>67414-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kristalose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074712</ApplicationNumber>
<LabelerName>Jones Contract Packaging Services</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-719-31</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (67877-719-31) / 10 TABLET in 1 BLISTER PACK (67877-719-33) </PackageDescription>
<NDC11Code>67877-0719-31</NDC11Code>
<ProductNDC>67877-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214138</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk (1.3) Recipients of transplanted organs other than kidney or liver (1.3, 5.7) Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R) 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36 dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>68016-719-20</NDCCode>
<PackageDescription>2 CARTON in 1 BLISTER PACK (68016-719-20) > 10 CAPSULE in 1 CARTON</PackageDescription>
<NDC11Code>68016-0719-20</NDC11Code>
<ProductNDC>68016-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Cold And Flu Relief Plus</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Chain Drug Consortium, LCC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71205-719-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71205-719-10) </PackageDescription>
<NDC11Code>71205-0719-10</NDC11Code>
<ProductNDC>71205-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. Tablets - Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>71288-719-11</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-10) </PackageDescription>
<NDC11Code>71288-0719-11</NDC11Code>
<ProductNDC>71288-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20211019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214514</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4·2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl]-, dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, crystalline powder, very soluble in water. It has the following structural formula. Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) multi-dose fliptop vials contains: 20 mg of succinylcholine chloride anhydrous (equivalent to 22 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben, NF and 0.2 mg of propylparaben, NF as preservatives, 4.7 mg of sodium chloride, USP as iso-osmotic agent, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters in water for injection, USP. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>71288-719-92</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-719-92) / 10 mL in 1 VIAL, MULTI-DOSE (71288-719-91) </PackageDescription>
<NDC11Code>71288-0719-92</NDC11Code>
<ProductNDC>71288-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20211019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214514</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4·2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl]-, dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, crystalline powder, very soluble in water. It has the following structural formula. Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection, USP 200 mg per 10 mL (20 mg per mL) multi-dose fliptop vials contains: 20 mg of succinylcholine chloride anhydrous (equivalent to 22 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben, NF and 0.2 mg of propylparaben, NF as preservatives, 4.7 mg of sodium chloride, USP as iso-osmotic agent, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters in water for injection, USP. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>71919-719-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-719-10) </PackageDescription>
<NDC11Code>71919-0719-10</NDC11Code>
<ProductNDC>71919-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wyethia Helenioides</ProprietaryName>
<NonProprietaryName>Wyethia Helenioides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76420-719-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (76420-719-10) </PackageDescription>
<NDC11Code>76420-0719-10</NDC11Code>
<ProductNDC>76420-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-001-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) </PackageDescription>
<NDC11Code>43598-0001-10</NDC11Code>
<ProductNDC>43598-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-10</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) </PackageDescription>
<NDC11Code>43598-0002-10</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-008-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) </PackageDescription>
<NDC11Code>43598-0008-10</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-009-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) </PackageDescription>
<NDC11Code>43598-0009-10</NDC11Code>
<ProductNDC>43598-009</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-027-48</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43598-027-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-029-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-028-35) </PackageDescription>
<NDC11Code>43598-0027-48</NDC11Code>
<ProductNDC>43598-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203655</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
<Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>43598-032-37</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>43598-0032-37</NDC11Code>
<ProductNDC>43598-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215820</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>43598-053-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (43598-053-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>43598-0053-11</NDC11Code>
<ProductNDC>43598-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215961</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>43598-078-58</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) </PackageDescription>
<NDC11Code>43598-0078-58</NDC11Code>
<ProductNDC>43598-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalaprilat</ProprietaryName>
<NonProprietaryName>Enalaprilat</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075578</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ENALAPRILAT</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>43598-086-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>43598-0086-58</NDC11Code>
<ProductNDC>43598-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<ProprietaryNameSuffix>Doxycycline</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218753</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).</IndicationAndUsage>
<Description>Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
</NDC>
<NDC>
<NDCCode>43598-087-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58) / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) </PackageDescription>
<NDC11Code>43598-0087-58</NDC11Code>
<ProductNDC>43598-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217718</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
</NDCList>