{
"NDC": [
{
"NDCCode": "63304-772-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (63304-772-10) ",
"NDC11Code": "63304-0772-10",
"ProductNDC": "63304-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES INC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "63304-772-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (63304-772-01) ",
"NDC11Code": "63304-0772-01",
"ProductNDC": "63304-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES INC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "63304-772-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (63304-772-05) ",
"NDC11Code": "63304-0772-05",
"ProductNDC": "63304-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES INC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "63304-772-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63304-772-30)",
"NDC11Code": "63304-0772-30",
"ProductNDC": "63304-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63304-772-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-772-90) ",
"NDC11Code": "63304-0772-90",
"ProductNDC": "63304-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES INC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "10515-772-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-772-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0772-00",
"ProductNDC": "10515-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062772",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080306",
"SamplePackage": "N"
},
{
"NDCCode": "16571-772-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-772-10) ",
"NDC11Code": "16571-0772-10",
"ProductNDC": "16571-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091163",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110330",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, 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. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "23155-772-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-772-10) ",
"NDC11Code": "23155-0772-10",
"ProductNDC": "23155-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075479",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP 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 enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, 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, Head and Neck Angioedema).",
"Description": "Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake."
},
{
"NDCCode": "31722-772-32",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (31722-772-32) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0772-32",
"ProductNDC": "31722-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210236",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "42291-772-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (42291-772-10) ",
"NDC11Code": "42291-0772-10",
"ProductNDC": "42291-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extended Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040765",
"LabelerName": "AvKARE",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200825",
"SamplePackage": "N",
"IndicationAndUsage": "Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.",
"Description": "Phenytoin sodium, USP is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 5."
},
{
"NDCCode": "45865-772-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (45865-772-01) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "45865-0772-01",
"ProductNDC": "45865-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20050121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076673",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:.",
"Description": "Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: acetic acid, edetate disodium 0.05%, mannitol 4.6%, purified water, sodium acetate, hydrochloric acid and/or sodium hydroxide may be used to adjust pH. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
},
{
"NDCCode": "46708-772-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (46708-772-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "46708-0772-10",
"ProductNDC": "46708-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217278",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile."
},
{
"NDCCode": "50844-772-03",
"PackageDescription": "10 PACKET in 1 CARTON (50844-772-03) / 17 g in 1 PACKET",
"NDC11Code": "50844-0772-03",
"ProductNDC": "50844-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217505",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "51991-772-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51991-772-10) ",
"NDC11Code": "51991-0772-10",
"ProductNDC": "51991-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121218",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121218",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "60429-772-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (60429-772-10) ",
"NDC11Code": "60429-0772-10",
"ProductNDC": "60429-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110708",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "62157-772-01",
"PackageDescription": "10 g in 1 JAR (62157-772-01)",
"NDC11Code": "62157-0772-01",
"ProductNDC": "62157-772",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cidofovir Dihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "CIDOFOVIR",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "62332-772-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62332-772-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "62332-0772-10",
"ProductNDC": "62332-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217278",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile."
},
{
"NDCCode": "63868-772-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (63868-772-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "63868-0772-10",
"ProductNDC": "63868-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rest Simply",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140613",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140613",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness."
},
{
"NDCCode": "65601-772-10",
"PackageDescription": "900 mL in 1 BAG (65601-772-10)",
"NDC11Code": "65601-0772-10",
"ProductNDC": "65601-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Winning Hands Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65841-772-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30) ",
"NDC11Code": "65841-0772-77",
"ProductNDC": "65841-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201676",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230216",
"SamplePackage": "N"
},
{
"NDCCode": "68382-772-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-772-77) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-772-30) ",
"NDC11Code": "68382-0772-77",
"ProductNDC": "68382-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200816",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release orally disintegrating tablets are proton pump inhbitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H.pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release orally disintegrating tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5 and approximately 18 hours at pH 7. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each lansoprazole delayed-release orally disintegrating tablet intended for oral administration contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole and contains the following inactive ingredients: anhydrous colloidal silica, aspartame**, anhydrous citric acid, crospovidone, corn starch, ferric oxide red, flavour strawberry, glyceryl monostearate, hydrochloric acid, hypromellose, mannitol, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, microcrystalline cellulose silicified, microcrystalline cellulose spheres, magnesium stearate, magnesium carbonate, polyethylene glycol, polysorbate 80, polyacrylate dispersion, sodium hydroxide, sodium starch glycolate, talc, triethyl citrate and xanthan gum. ** Phenylketonurics: Contains Phenylalanine 1.6 mg per 15 mg tablet and 3.28 mg per 30 mg tablet."
},
{
"NDCCode": "68462-772-10",
"PackageDescription": "10 VIAL in 1 CARTON (68462-772-10) / 5 mL in 1 VIAL",
"NDC11Code": "68462-0772-10",
"ProductNDC": "68462-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219273",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "MICAFUNGIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)], 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. .",
"Description": "Micafungin for Injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "68479-772-01",
"PackageDescription": "10 mL in 1 BOTTLE (68479-772-01) ",
"NDC11Code": "68479-0772-01",
"ProductNDC": "68479-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breakout Clearing Booster",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210409",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Dermalogica, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "72611-779-02",
"PackageDescription": "1 KIT in 1 CARTON (72611-779-02) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-776-01) ",
"NDC11Code": "72611-0779-02",
"ProductNDC": "72611-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204817",
"LabelerName": "Almaject, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201101",
"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. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. 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 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 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan hydrochloride for injection is administered intravenously."
},
{
"NDCCode": "76420-772-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL (72266-118-01) ",
"NDC11Code": "76420-0772-01",
"ProductNDC": "76420-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorocaine Lm Kit",
"NonProprietaryName": "Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine",
"DosageFormName": "KIT",
"RouteName": "EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL",
"StartMarketingDate": "20140811",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Asclemed USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210923",
"SamplePackage": "N"
},
{
"NDCCode": "63304-076-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-10) ",
"NDC11Code": "63304-0076-10",
"ProductNDC": "63304-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride Extended-release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076368",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191120",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "The Potassium Chloride Extended Release Tablets, USP, 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets, USP, 10mEq are an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets, USP, 10mEq are a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets, USP, 10 mEq begin disintegrating into micro-encapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. FDA approved dissolution test specifications differ from USP. Inactive Ingredients:Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethylcellulose, microcrystalline cellulose."
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{
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"PackageDescription": "1000 TABLET, SUGAR COATED in 1 BOTTLE (63304-083-10) ",
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"ProductNDC": "63304-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine",
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"RouteName": "ORAL",
"StartMarketingDate": "20201118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214256",
"LabelerName": "Sun Pharmaceutical Industries Inc",
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"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. C 17H 19ClN 2S. HCl. M.W.355.33 g/mol. Chlorpromazine hydrochloride occurs as white or slightly creamy white, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: calcium sulfate dihydrate, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, polyethylene glycol, propylene glycol, shellac glaze, sucrose and talc. FDA approved dissolution test specifications differ from USP."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erlotinib",
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"LabelerName": "Sun Pharmaceutical Industries, Inc.",
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"IndicationAndUsage": "Erlotinib tablets are kinase inhibitors indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
"Description": "Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)‑4-quinazolinamine hydrochloride. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride is off-white to pale yellow powder and has the molecular formula C22H24ClN3O4 and a molecular weight of 429.90. The molecule has a pKa of about 4.44 at 25°C. Erlotinib hydrochloride is slightly soluble in methanol; practically insoluble in acetonitrile and in acetone. Erlotinib hydrochloride is insoluble over the pH range of 1.2 to 8.0. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide."
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"Description": "Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)‑4-quinazolinamine hydrochloride. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride is off-white to pale yellow powder and has the molecular formula C22H24ClN3O4 and a molecular weight of 429.90. The molecule has a pKa of about 4.44 at 25°C. Erlotinib hydrochloride is slightly soluble in methanol; practically insoluble in acetonitrile and in acetone. Erlotinib hydrochloride is insoluble over the pH range of 1.2 to 8.0. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide."
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{
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"ProductNDC": "63304-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. C 17H 19ClN 2S. HCl. M.W.355.33 g/mol. Chlorpromazine hydrochloride occurs as white or slightly creamy white, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: calcium sulfate dihydrate, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, polyethylene glycol, propylene glycol, shellac glaze, sucrose and talc. FDA approved dissolution test specifications differ from USP."
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<StartMarketingDatePackage>20110330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, 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. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>23155-772-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-772-10) </PackageDescription>
<NDC11Code>23155-0772-10</NDC11Code>
<ProductNDC>23155-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075479</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP 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 enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, 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, Head and Neck Angioedema).</IndicationAndUsage>
<Description>Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>31722-772-32</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (31722-772-32) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0772-32</NDC11Code>
<ProductNDC>31722-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210236</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>42291-772-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (42291-772-10) </PackageDescription>
<NDC11Code>42291-0772-10</NDC11Code>
<ProductNDC>42291-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extended Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040765</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.</IndicationAndUsage>
<Description>Phenytoin sodium, USP is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: D&C Red #28, D&C Red #33, FD&C Blue #1, gelatin, hydroxypropyl cellulose, mannitol, magnesium stearate, talc and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>45865-772-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (45865-772-01) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>45865-0772-01</NDC11Code>
<ProductNDC>45865-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20050121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076673</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:.</IndicationAndUsage>
<Description>Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: acetic acid, edetate disodium 0.05%, mannitol 4.6%, purified water, sodium acetate, hydrochloric acid and/or sodium hydroxide may be used to adjust pH. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>46708-772-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (46708-772-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46708-0772-10</NDC11Code>
<ProductNDC>46708-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217278</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>50844-772-03</NDCCode>
<PackageDescription>10 PACKET in 1 CARTON (50844-772-03) / 17 g in 1 PACKET</PackageDescription>
<NDC11Code>50844-0772-03</NDC11Code>
<ProductNDC>50844-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217505</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51991-772-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51991-772-10) </PackageDescription>
<NDC11Code>51991-0772-10</NDC11Code>
<ProductNDC>51991-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121218</StartMarketingDate>
<EndMarketingDate>20210531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121218</StartMarketingDatePackage>
<EndMarketingDatePackage>20210531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-772-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (60429-772-10) </PackageDescription>
<NDC11Code>60429-0772-10</NDC11Code>
<ProductNDC>60429-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110708</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62157-772-01</NDCCode>
<PackageDescription>10 g in 1 JAR (62157-772-01)</PackageDescription>
<NDC11Code>62157-0772-01</NDC11Code>
<ProductNDC>62157-772</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cidofovir Dihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>CIDOFOVIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62332-772-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (62332-772-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0772-10</NDC11Code>
<ProductNDC>62332-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217278</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>63868-772-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (63868-772-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>63868-0772-10</NDC11Code>
<ProductNDC>63868-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rest Simply</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140613</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140613</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65601-772-10</NDCCode>
<PackageDescription>900 mL in 1 BAG (65601-772-10)</PackageDescription>
<NDC11Code>65601-0772-10</NDC11Code>
<ProductNDC>65601-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Winning Hands Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65841-772-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30) </PackageDescription>
<NDC11Code>65841-0772-77</NDC11Code>
<ProductNDC>65841-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201676</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-772-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-772-77) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-772-30) </PackageDescription>
<NDC11Code>68382-0772-77</NDC11Code>
<ProductNDC>68382-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200816</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release orally disintegrating tablets are proton pump inhbitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H.pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release orally disintegrating tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5 and approximately 18 hours at pH 7. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each lansoprazole delayed-release orally disintegrating tablet intended for oral administration contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole and contains the following inactive ingredients: anhydrous colloidal silica, aspartame**, anhydrous citric acid, crospovidone, corn starch, ferric oxide red, flavour strawberry, glyceryl monostearate, hydrochloric acid, hypromellose, mannitol, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, microcrystalline cellulose silicified, microcrystalline cellulose spheres, magnesium stearate, magnesium carbonate, polyethylene glycol, polysorbate 80, polyacrylate dispersion, sodium hydroxide, sodium starch glycolate, talc, triethyl citrate and xanthan gum. ** Phenylketonurics: Contains Phenylalanine 1.6 mg per 15 mg tablet and 3.28 mg per 30 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>68462-772-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (68462-772-10) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>68462-0772-10</NDC11Code>
<ProductNDC>68462-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micafungin</ProprietaryName>
<NonProprietaryName>Micafungin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219273</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>MICAFUNGIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin for injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)], 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]., 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. .</IndicationAndUsage>
<Description>Micafungin for Injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
</NDC>
<NDC>
<NDCCode>68479-772-01</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (68479-772-01) </PackageDescription>
<NDC11Code>68479-0772-01</NDC11Code>
<ProductNDC>68479-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breakout Clearing Booster</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Dermalogica, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72611-779-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72611-779-02) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72611-776-01) </PackageDescription>
<NDC11Code>72611-0779-02</NDC11Code>
<ProductNDC>72611-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204817</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</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. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. 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 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 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan hydrochloride for injection is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>76420-772-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL (72266-118-01) </PackageDescription>
<NDC11Code>76420-0772-01</NDC11Code>
<ProductNDC>76420-772</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorocaine Lm Kit</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL</RouteName>
<StartMarketingDate>20140811</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63304-076-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-076-10) </PackageDescription>
<NDC11Code>63304-0076-10</NDC11Code>
<ProductNDC>63304-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride Extended-release</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076368</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>The Potassium Chloride Extended Release Tablets, USP, 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets, USP, 10mEq are an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets, USP, 10mEq are a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets, USP, 10 mEq begin disintegrating into micro-encapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. FDA approved dissolution test specifications differ from USP. Inactive Ingredients:Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethylcellulose, microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>63304-083-10</NDCCode>
<PackageDescription>1000 TABLET, SUGAR COATED in 1 BOTTLE (63304-083-10) </PackageDescription>
<NDC11Code>63304-0083-10</NDC11Code>
<ProductNDC>63304-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214256</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Inc</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. C 17H 19ClN 2S. HCl. M.W.355.33 g/mol. Chlorpromazine hydrochloride occurs as white or slightly creamy white, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: calcium sulfate dihydrate, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, polyethylene glycol, propylene glycol, shellac glaze, sucrose and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>63304-095-11</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (63304-095-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-095-31) </PackageDescription>
<NDC11Code>63304-0095-11</NDC11Code>
<ProductNDC>63304-095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erlotinib</ProprietaryName>
<NonProprietaryName>Erlotinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210300</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ERLOTINIB</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erlotinib tablets are kinase inhibitors indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
<Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)‑4-quinazolinamine hydrochloride. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride is off-white to pale yellow powder and has the molecular formula C22H24ClN3O4 and a molecular weight of 429.90. The molecule has a pKa of about 4.44 at 25°C. Erlotinib hydrochloride is slightly soluble in methanol; practically insoluble in acetonitrile and in acetone. Erlotinib hydrochloride is insoluble over the pH range of 1.2 to 8.0. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide.</Description>
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<NDCCode>63304-096-11</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (63304-096-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-096-31) </PackageDescription>
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<ProductNDC>63304-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erlotinib</ProprietaryName>
<NonProprietaryName>Erlotinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210300</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ERLOTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erlotinib tablets are kinase inhibitors indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
<Description>Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)‑4-quinazolinamine hydrochloride. Erlotinib tablets contain erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride is off-white to pale yellow powder and has the molecular formula C22H24ClN3O4 and a molecular weight of 429.90. The molecule has a pKa of about 4.44 at 25°C. Erlotinib hydrochloride is slightly soluble in methanol; practically insoluble in acetonitrile and in acetone. Erlotinib hydrochloride is insoluble over the pH range of 1.2 to 8.0. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63304-114-10</NDCCode>
<PackageDescription>1000 TABLET, SUGAR COATED in 1 BOTTLE (63304-114-10) </PackageDescription>
<NDC11Code>63304-0114-10</NDC11Code>
<ProductNDC>63304-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214256</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Inc</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, USP, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. C 17H 19ClN 2S. HCl. M.W.355.33 g/mol. Chlorpromazine hydrochloride occurs as white or slightly creamy white, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: calcium sulfate dihydrate, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, polyethylene glycol, propylene glycol, shellac glaze, sucrose and talc. FDA approved dissolution test specifications differ from USP.</Description>
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