{
"NDC": [
{
"NDCCode": "62332-633-30",
"PackageDescription": "30 POUCH in 1 CARTON (62332-633-30) / 1 VIAL in 1 POUCH (62332-633-01) / 2 mL in 1 VIAL",
"NDC11Code": "62332-0633-30",
"ProductNDC": "62332-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arformoterol Tartrate",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214779",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220510",
"SamplePackage": "N",
"IndicationAndUsage": "Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEBTM 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
},
{
"NDCCode": "62332-633-60",
"PackageDescription": "60 POUCH in 1 CARTON (62332-633-60) / 4 VIAL in 1 POUCH (62332-633-04) / 2 mL in 1 VIAL",
"NDC11Code": "62332-0633-60",
"ProductNDC": "62332-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arformoterol Tartrate",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20220510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214779",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220510",
"SamplePackage": "N",
"IndicationAndUsage": "Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEBTM 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
},
{
"NDCCode": "10544-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-633-30)",
"NDC11Code": "10544-0633-30",
"ProductNDC": "10544-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075657",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.",
"Description": "Enalapril Maleate 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]-Lproline, ( Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, 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 is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and the 10 mg and 20 mg tablets also contain iron oxide red."
},
{
"NDCCode": "13537-633-18",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-633-18) > 30 mL in 1 BOTTLE (13537-633-17) ",
"NDC11Code": "13537-0633-18",
"ProductNDC": "13537-633",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hydro-nutritive Foundation Spf 15",
"ProprietaryNameSuffix": "(rosa 3) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".05; .02",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "36800-633-65",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-633-65) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "36800-0633-65",
"ProductNDC": "36800-633",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Anti Diarrheal Anti Gas",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209837",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N"
},
{
"NDCCode": "42783-633-30",
"PackageDescription": "1 KIT in 1 KIT (42783-633-30) * 30 TABLET, FILM COATED in 1 BOTTLE (42783-601-30) * 104 mL in 1 TUBE (42783-635-04)",
"NDC11Code": "42783-0633-30",
"ProductNDC": "42783-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzodox 30 Kit",
"NonProprietaryName": "Doxycycline Tablets And Advanced Acne Wash",
"DosageFormName": "KIT",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Elorac, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Doxycycline tablets, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent to 100 mg of doxycycline for oral administration. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Structural formula. Doxycycline tablets, USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form."
},
{
"NDCCode": "43744-633-30",
"PackageDescription": "50 g in 1 DRUM (43744-633-30)",
"NDC11Code": "43744-0633-30",
"ProductNDC": "43744-633",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mupirocin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MUPIROCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "45865-633-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-633-30) ",
"NDC11Code": "45865-0633-30",
"ProductNDC": "45865-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206674",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablet (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .",
"Description": "Bupropion hydrochloride USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hydroxy propyl methyl cellulose, diluted hydrochloric acid, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, the 100 mg-tablet contains FD&C Blue No. 1 Aluminum lake, the 150 mg- tablet contains FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake and the 200 mg-tablet contains FD&C Red No. 40 Aluminum lake. USP Dissolution Test Pending."
},
{
"NDCCode": "46672-633-01",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (46672-633-01) ",
"NDC11Code": "46672-0633-01",
"ProductNDC": "46672-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20030131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040387",
"LabelerName": "Mikart, LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2020-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20030131",
"SamplePackage": "N"
},
{
"NDCCode": "55289-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55289-633-30) ",
"NDC11Code": "55289-0633-30",
"ProductNDC": "55289-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorzoxazone",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110831",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.",
"Description": "Chlorzoxazone, USP is a centrally-acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone, USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone Tablets, USP contain the inactive ingredients docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellullose, pregelatinized starch, sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (55700-633-30) ",
"NDC11Code": "55700-0633-30",
"ProductNDC": "55700-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202413",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180525",
"SamplePackage": "N"
},
{
"NDCCode": "60429-633-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-633-30) ",
"NDC11Code": "60429-0633-30",
"ProductNDC": "60429-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091151",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210222",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5 H-pyrrolo[3,4- b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: black iron oxide, colloidal silicon dioxide, croscarmellose sodium type A, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "61269-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (61269-633-30) ",
"NDC11Code": "61269-0633-30",
"ProductNDC": "61269-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyprexa",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020592",
"LabelerName": "H2-Pharma LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961001",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPREXA® (olanzapine) is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
},
{
"NDCCode": "62756-633-83",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-633-83)",
"NDC11Code": "62756-0633-83",
"ProductNDC": "62756-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "63187-633-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (63187-633-30) ",
"NDC11Code": "63187-0633-30",
"ProductNDC": "63187-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib 200 Mg",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2019-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151124",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake."
},
{
"NDCCode": "64850-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (64850-633-30) ",
"NDC11Code": "64850-0633-30",
"ProductNDC": "64850-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209924",
"LabelerName": "Elite Laboratories, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181116",
"SamplePackage": "N"
},
{
"NDCCode": "64980-633-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-633-03) ",
"NDC11Code": "64980-0633-03",
"ProductNDC": "64980-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212949",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240726",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy 3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 4.5 mg esomeprazole magnesium trihydrate) in the form of entericcoatedgranules with the following inactive ingredients: FD&C Blue #1, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium bicarbonate, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "65841-633-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-633-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65841-0633-30",
"ProductNDC": "65841-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N"
},
{
"NDCCode": "70934-633-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70934-633-30) ",
"NDC11Code": "70934-0633-30",
"ProductNDC": "70934-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076059",
"LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200321",
"SamplePackage": "N"
},
{
"NDCCode": "71205-633-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71205-633-30) ",
"NDC11Code": "71205-0633-30",
"ProductNDC": "71205-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "OROPHARYNGEAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091166",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220120",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
},
{
"NDCCode": "71610-633-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) ",
"NDC11Code": "71610-0633-30",
"ProductNDC": "71610-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220207",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "71919-633-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-633-08) ",
"NDC11Code": "71919-0633-08",
"ProductNDC": "71919-633",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solanum Nigrum",
"NonProprietaryName": "Solanum Nigrum Whole",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090612",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SOLANUM NIGRUM WHOLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090612",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. SOLANUM NIG Headache."
},
{
"NDCCode": "72189-633-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72189-633-30) ",
"NDC11Code": "72189-0633-30",
"ProductNDC": "72189-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hcl",
"NonProprietaryName": "Doxepin Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215113",
"LabelerName": "Direct_Rx",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250722",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of. Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white, crystalline powder freely soluble in water, in ethanol and in dichloromethane. Soluble in chloroform and in methanol. It may be represented by the following structural formula. [stru]. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethyl-,hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin hydrochloride capsules, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac. FDA approved dissolution method differs from the USP dissolution method."
},
{
"NDCCode": "75622-633-30",
"PackageDescription": "50 CLOTH in 1 CANISTER (75622-633-30) ",
"NDC11Code": "75622-0633-30",
"ProductNDC": "75622-633",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Deyo",
"NonProprietaryName": "Disinfecting Wet Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Henan Yeesain Health Technology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "mL/1",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201009",
"SamplePackage": "N",
"IndicationAndUsage": "For sanitizing to help in reducing bacteria on the skin."
},
{
"NDCCode": "76420-633-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-30) ",
"NDC11Code": "76420-0633-30",
"ProductNDC": "76420-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "84682-633-01",
"PackageDescription": "30 g in 1 BOX (84682-633-01) ",
"NDC11Code": "84682-0633-01",
"ProductNDC": "84682-633",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyaluronic Acidintensive Cream",
"NonProprietaryName": "Hyaluronic Acidintensive Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241024",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241024",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "62332-001-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62332-001-30) ",
"NDC11Code": "62332-0001-30",
"ProductNDC": "62332-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078916",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "62332-002-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62332-002-30) ",
"NDC11Code": "62332-0002-30",
"ProductNDC": "62332-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078916",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "62332-008-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62332-008-30) ",
"NDC11Code": "62332-0008-30",
"ProductNDC": "62332-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078932",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone."
},
{
"NDCCode": "62332-009-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62332-009-30) ",
"NDC11Code": "62332-0009-30",
"ProductNDC": "62332-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078932",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62332-633-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (62332-633-30) / 1 VIAL in 1 POUCH (62332-633-01) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0633-30</NDC11Code>
<ProductNDC>62332-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arformoterol Tartrate</ProprietaryName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214779</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEBTM 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
</NDC>
<NDC>
<NDCCode>62332-633-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (62332-633-60) / 4 VIAL in 1 POUCH (62332-633-04) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0633-60</NDC11Code>
<ProductNDC>62332-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arformoterol Tartrate</ProprietaryName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20220510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214779</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arformoterol tartrate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>Arformoterol tartrate inhalation solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. Arformoterol tartrate inhalation solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.Arformoterol tartrate inhalation solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEBTM 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol tartrate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
</NDC>
<NDC>
<NDCCode>10544-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-633-30)</PackageDescription>
<NDC11Code>10544-0633-30</NDC11Code>
<ProductNDC>10544-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075657</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril Maleate 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]-Lproline, ( Z)-2-butenedioate salt (1:1). Its empirical formula is C 20H 28N 2O 5C 4H 4O 4, 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 is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and the 10 mg and 20 mg tablets also contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>13537-633-18</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-633-18) > 30 mL in 1 BOTTLE (13537-633-17) </PackageDescription>
<NDC11Code>13537-0633-18</NDC11Code>
<ProductNDC>13537-633</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hydro-nutritive Foundation Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(rosa 3) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.05; .02</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-633-65</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-633-65) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0633-65</NDC11Code>
<ProductNDC>36800-633</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Anti Diarrheal Anti Gas</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209837</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42783-633-30</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42783-633-30) * 30 TABLET, FILM COATED in 1 BOTTLE (42783-601-30) * 104 mL in 1 TUBE (42783-635-04)</PackageDescription>
<NDC11Code>42783-0633-30</NDC11Code>
<ProductNDC>42783-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzodox 30 Kit</ProprietaryName>
<NonProprietaryName>Doxycycline Tablets And Advanced Acne Wash</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Elorac, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Doxycycline tablets, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent to 100 mg of doxycycline for oral administration. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Structural formula. Doxycycline tablets, USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.</Description>
</NDC>
<NDC>
<NDCCode>43744-633-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-633-30)</PackageDescription>
<NDC11Code>43744-0633-30</NDC11Code>
<ProductNDC>43744-633</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mupirocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MUPIROCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-633-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-633-30) </PackageDescription>
<NDC11Code>45865-0633-30</NDC11Code>
<ProductNDC>45865-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (sr)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206674</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)] . The efficacy of bupropion hydrochloride extended-release tablet (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hydroxy propyl methyl cellulose, diluted hydrochloric acid, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, the 100 mg-tablet contains FD&C Blue No. 1 Aluminum lake, the 150 mg- tablet contains FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake and the 200 mg-tablet contains FD&C Red No. 40 Aluminum lake. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>46672-633-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (46672-633-01) </PackageDescription>
<NDC11Code>46672-0633-01</NDC11Code>
<ProductNDC>46672-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040387</ApplicationNumber>
<LabelerName>Mikart, LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55289-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-633-30) </PackageDescription>
<NDC11Code>55289-0633-30</NDC11Code>
<ProductNDC>55289-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorzoxazone</ProprietaryName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089859</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Chlorzoxazone, USP is a centrally-acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is. Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone, USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone Tablets, USP contain the inactive ingredients docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellullose, pregelatinized starch, sodium benzoate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>55700-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (55700-633-30) </PackageDescription>
<NDC11Code>55700-0633-30</NDC11Code>
<ProductNDC>55700-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202413</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-633-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-633-30) </PackageDescription>
<NDC11Code>60429-0633-30</NDC11Code>
<ProductNDC>60429-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091151</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5 H-pyrrolo[3,4- b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: black iron oxide, colloidal silicon dioxide, croscarmellose sodium type A, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>61269-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (61269-633-30) </PackageDescription>
<NDC11Code>61269-0633-30</NDC11Code>
<ProductNDC>61269-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyprexa</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020592</ApplicationNumber>
<LabelerName>H2-Pharma LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>62756-633-83</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-633-83)</PackageDescription>
<NDC11Code>62756-0633-83</NDC11Code>
<ProductNDC>62756-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-633-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (63187-633-30) </PackageDescription>
<NDC11Code>63187-0633-30</NDC11Code>
<ProductNDC>63187-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib 200 Mg</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>64850-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (64850-633-30) </PackageDescription>
<NDC11Code>64850-0633-30</NDC11Code>
<ProductNDC>64850-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209924</ApplicationNumber>
<LabelerName>Elite Laboratories, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-633-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-633-03) </PackageDescription>
<NDC11Code>64980-0633-03</NDC11Code>
<ProductNDC>64980-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212949</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy 3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 4.5 mg esomeprazole magnesium trihydrate) in the form of entericcoatedgranules with the following inactive ingredients: FD&C Blue #1, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium bicarbonate, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65841-633-30</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-633-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65841-0633-30</NDC11Code>
<ProductNDC>65841-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70934-633-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70934-633-30) </PackageDescription>
<NDC11Code>70934-0633-30</NDC11Code>
<ProductNDC>70934-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076059</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-633-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71205-633-30) </PackageDescription>
<NDC11Code>71205-0633-30</NDC11Code>
<ProductNDC>71205-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>OROPHARYNGEAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091166</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>71610-633-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) </PackageDescription>
<NDC11Code>71610-0633-30</NDC11Code>
<ProductNDC>71610-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-633-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-633-08) </PackageDescription>
<NDC11Code>71919-0633-08</NDC11Code>
<ProductNDC>71919-633</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solanum Nigrum</ProprietaryName>
<NonProprietaryName>Solanum Nigrum Whole</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SOLANUM NIGRUM WHOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. SOLANUM NIG Headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72189-633-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72189-633-30) </PackageDescription>
<NDC11Code>72189-0633-30</NDC11Code>
<ProductNDC>72189-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hcl</ProprietaryName>
<NonProprietaryName>Doxepin Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215113</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of. Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white, crystalline powder freely soluble in water, in ethanol and in dichloromethane. Soluble in chloroform and in methanol. It may be represented by the following structural formula. [stru]. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethyl-,hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin hydrochloride capsules, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac. FDA approved dissolution method differs from the USP dissolution method.</Description>
</NDC>
<NDC>
<NDCCode>75622-633-30</NDCCode>
<PackageDescription>50 CLOTH in 1 CANISTER (75622-633-30) </PackageDescription>
<NDC11Code>75622-0633-30</NDC11Code>
<ProductNDC>75622-633</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Deyo</ProprietaryName>
<NonProprietaryName>Disinfecting Wet Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Henan Yeesain Health Technology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For sanitizing to help in reducing bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-633-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-30) </PackageDescription>
<NDC11Code>76420-0633-30</NDC11Code>
<ProductNDC>76420-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>84682-633-01</NDCCode>
<PackageDescription>30 g in 1 BOX (84682-633-01) </PackageDescription>
<NDC11Code>84682-0633-01</NDC11Code>
<ProductNDC>84682-633</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyaluronic Acidintensive Cream</ProprietaryName>
<NonProprietaryName>Hyaluronic Acidintensive Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241024</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241024</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62332-001-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62332-001-30) </PackageDescription>
<NDC11Code>62332-0001-30</NDC11Code>
<ProductNDC>62332-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078916</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>62332-002-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62332-002-30) </PackageDescription>
<NDC11Code>62332-0002-30</NDC11Code>
<ProductNDC>62332-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078916</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>62332-008-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62332-008-30) </PackageDescription>
<NDC11Code>62332-0008-30</NDC11Code>
<ProductNDC>62332-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078932</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>62332-009-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62332-009-30) </PackageDescription>
<NDC11Code>62332-0009-30</NDC11Code>
<ProductNDC>62332-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078932</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
</NDC>
</NDCList>