{
"NDC": [
{
"NDCCode": "69339-184-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-184-03) ",
"NDC11Code": "69339-0184-03",
"ProductNDC": "69339-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-136-34",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) ",
"NDC11Code": "69339-0136-34",
"ProductNDC": "69339-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210363",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
"Description": "Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative."
},
{
"NDCCode": "69339-168-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) ",
"NDC11Code": "69339-0168-03",
"ProductNDC": "69339-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gefitinib",
"NonProprietaryName": "Gefitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212827",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "GEFITINIB",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230605",
"SamplePackage": "N",
"IndicationAndUsage": "Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [seeClinical Studies (14)].",
"Description": "Gefitinib is a kinase inhibitor. The chemical name of gefitinib is N-(3ʹ-Chloro-4ʹ-fluorophenyl)-7-methoxy-6-{3-(4- morpholinyl)proproxy}-4-quinazolinamine and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a White to off-white crystalline powder. Gefitinib is a free base. The molecule has pKa1 is 6.5 & pKa2 is 6.9. Gefitinib can be defined as soluble at pH 1, but insoluble above pH 7, freely soluble in dimethylformamide and acetic acid, slightly soluble in methanol. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, and sodium lauryl sulfate and magnesium stearate. Tablet coating contains: polyvinyl alcohol, polyethylene glycol/PEG, talc, titanium dioxide, yellow iron oxide and red iron oxide."
},
{
"NDCCode": "69339-169-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-169-03) ",
"NDC11Code": "69339-0169-03",
"ProductNDC": "69339-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209555",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "69339-170-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-170-03) ",
"NDC11Code": "69339-0170-03",
"ProductNDC": "69339-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209555",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "69339-171-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-171-03) ",
"NDC11Code": "69339-0171-03",
"ProductNDC": "69339-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221024",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "69339-172-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-172-03) ",
"NDC11Code": "69339-0172-03",
"ProductNDC": "69339-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221024",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3."
},
{
"NDCCode": "69339-177-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-177-03) ",
"NDC11Code": "69339-0177-03",
"ProductNDC": "69339-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202768",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230323",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch."
},
{
"NDCCode": "69339-178-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-178-03) ",
"NDC11Code": "69339-0178-03",
"ProductNDC": "69339-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202768",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230323",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch."
},
{
"NDCCode": "69339-179-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-179-03) ",
"NDC11Code": "69339-0179-03",
"ProductNDC": "69339-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202768",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230323",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch."
},
{
"NDCCode": "69339-180-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-180-03) ",
"NDC11Code": "69339-0180-03",
"ProductNDC": "69339-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202768",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230323",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch."
},
{
"NDCCode": "69339-181-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-181-03) ",
"NDC11Code": "69339-0181-03",
"ProductNDC": "69339-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-182-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03) ",
"NDC11Code": "69339-0182-03",
"ProductNDC": "69339-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-183-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-183-03) ",
"NDC11Code": "69339-0183-03",
"ProductNDC": "69339-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-185-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-185-03) ",
"NDC11Code": "69339-0185-03",
"ProductNDC": "69339-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-186-03",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-186-03) ",
"NDC11Code": "69339-0186-03",
"ProductNDC": "69339-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20231014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231014",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "69339-236-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (69339-236-03) ",
"NDC11Code": "69339-0236-03",
"ProductNDC": "69339-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075831",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241125",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "BISOPROLOL FUMARATE USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2- (1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2- butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta- blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide."
},
{
"NDCCode": "69339-237-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (69339-237-03) ",
"NDC11Code": "69339-0237-03",
"ProductNDC": "69339-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075831",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241125",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "BISOPROLOL FUMARATE USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2- (1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2- butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta- blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide."
},
{
"NDCCode": "0135-0460-03",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0460-03) / 184.3 g in 1 TUBE",
"NDC11Code": "00135-0460-03",
"ProductNDC": "0135-0460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne Pronamel",
"ProprietaryNameSuffix": "Daily Protection",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20101018",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.15",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101018",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "16714-184-03",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-184-03) ",
"NDC11Code": "16714-0184-03",
"ProductNDC": "16714-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078406",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070725",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake."
},
{
"NDCCode": "24236-184-03",
"PackageDescription": "20 TABLET in 1 VIAL (24236-184-03)",
"NDC11Code": "24236-0184-03",
"ProductNDC": "24236-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-03-18"
},
{
"NDCCode": "49035-184-03",
"PackageDescription": "833 mL in 1 BOTTLE, PLASTIC (49035-184-03) ",
"NDC11Code": "49035-0184-03",
"ProductNDC": "49035-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Everyday Clean 2 In 1 Dandruff",
"ProprietaryNameSuffix": "Anti-dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "54340-184-03",
"PackageDescription": "8 BOTTLE, PUMP in 1 CARTON (54340-184-03) / 296 mL in 1 BOTTLE, PUMP",
"NDC11Code": "54340-0184-03",
"ProductNDC": "54340-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Foaming Antibacterial Defense Coconut Water",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "For handwasing to decrease bacteria on the skin."
},
{
"NDCCode": "62362-184-03",
"PackageDescription": "1 PACKAGE in 1 POUCH (62362-184-03) > 2 mL in 1 PACKAGE (62362-184-07)",
"NDC11Code": "62362-0184-03",
"ProductNDC": "62362-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neova Day Therapy",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Homosalate, Octocrylene, Octisalate, Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "PhotoMedex, Inc.",
"SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
"StrengthNumber": "7; 6; 5; 3",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63545-184-03",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-184-03) ",
"NDC11Code": "63545-0184-03",
"ProductNDC": "63545-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Bromatum",
"NonProprietaryName": "Arsenicum Bromatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210323",
"SamplePackage": "N"
},
{
"NDCCode": "64220-184-03",
"PackageDescription": "15 kg in 1 CANISTER (64220-184-03) ",
"NDC11Code": "64220-0184-03",
"ProductNDC": "64220-184",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140923",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-06-23",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "23-SEP-14"
},
{
"NDCCode": "64380-184-03",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-03) ",
"NDC11Code": "64380-0184-03",
"ProductNDC": "64380-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260523",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20oC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains Titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "64980-184-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-184-03)",
"NDC11Code": "64980-0184-03",
"ProductNDC": "64980-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202545",
"LabelerName": "Rising Pharmaceuticals, Inc",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate."
},
{
"NDCCode": "66506-184-03",
"PackageDescription": "1 TUBE in 1 PACKAGE (66506-184-03) / 20 g in 1 TUBE (66506-184-04) ",
"NDC11Code": "66506-0184-03",
"ProductNDC": "66506-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cheezheng Pain Relief Cream",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Tibet Cheezheng Tibetan Medicine Co. Ltd",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240527",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joint associated with. arthritis strains simple backache sprains."
},
{
"NDCCode": "68428-184-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-184-03) ",
"NDC11Code": "68428-0184-03",
"ProductNDC": "68428-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Agaricus Muscarius",
"NonProprietaryName": "Amanita Muscaria Var. Muscaria",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20091022",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69339-184-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-184-03) </PackageDescription>
<NDC11Code>69339-0184-03</NDC11Code>
<ProductNDC>69339-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-136-34</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) </PackageDescription>
<NDC11Code>69339-0136-34</NDC11Code>
<ProductNDC>69339-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210363</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures (See WARNINGS). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with a molecular weight of 284.74 and with the following molecular structure. M.W. 284.74Diazepam Injection, USP is a sterile solution and each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative.</Description>
</NDC>
<NDC>
<NDCCode>69339-168-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) </PackageDescription>
<NDC11Code>69339-0168-03</NDC11Code>
<ProductNDC>69339-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gefitinib</ProprietaryName>
<NonProprietaryName>Gefitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212827</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>GEFITINIB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [seeClinical Studies (14)].</IndicationAndUsage>
<Description>Gefitinib is a kinase inhibitor. The chemical name of gefitinib is N-(3ʹ-Chloro-4ʹ-fluorophenyl)-7-methoxy-6-{3-(4- morpholinyl)proproxy}-4-quinazolinamine and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a White to off-white crystalline powder. Gefitinib is a free base. The molecule has pKa1 is 6.5 & pKa2 is 6.9. Gefitinib can be defined as soluble at pH 1, but insoluble above pH 7, freely soluble in dimethylformamide and acetic acid, slightly soluble in methanol. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, and sodium lauryl sulfate and magnesium stearate. Tablet coating contains: polyvinyl alcohol, polyethylene glycol/PEG, talc, titanium dioxide, yellow iron oxide and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69339-169-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-169-03) </PackageDescription>
<NDC11Code>69339-0169-03</NDC11Code>
<ProductNDC>69339-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209555</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>69339-170-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-170-03) </PackageDescription>
<NDC11Code>69339-0170-03</NDC11Code>
<ProductNDC>69339-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209555</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>69339-171-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-171-03) </PackageDescription>
<NDC11Code>69339-0171-03</NDC11Code>
<ProductNDC>69339-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>69339-172-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-172-03) </PackageDescription>
<NDC11Code>69339-0172-03</NDC11Code>
<ProductNDC>69339-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.5. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>69339-177-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-177-03) </PackageDescription>
<NDC11Code>69339-0177-03</NDC11Code>
<ProductNDC>69339-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202768</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69339-178-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-178-03) </PackageDescription>
<NDC11Code>69339-0178-03</NDC11Code>
<ProductNDC>69339-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202768</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69339-179-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-179-03) </PackageDescription>
<NDC11Code>69339-0179-03</NDC11Code>
<ProductNDC>69339-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202768</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69339-180-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-180-03) </PackageDescription>
<NDC11Code>69339-0180-03</NDC11Code>
<ProductNDC>69339-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202768</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl] acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is freely soluble in dimethyl formamide, soluble in methanol, insoluble in water.Armodafinil tablets contain 50,150,200 and 250 mg of armodafinil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>69339-181-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-181-03) </PackageDescription>
<NDC11Code>69339-0181-03</NDC11Code>
<ProductNDC>69339-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-182-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03) </PackageDescription>
<NDC11Code>69339-0182-03</NDC11Code>
<ProductNDC>69339-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-183-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-183-03) </PackageDescription>
<NDC11Code>69339-0183-03</NDC11Code>
<ProductNDC>69339-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-185-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-185-03) </PackageDescription>
<NDC11Code>69339-0185-03</NDC11Code>
<ProductNDC>69339-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-186-03</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-186-03) </PackageDescription>
<NDC11Code>69339-0186-03</NDC11Code>
<ProductNDC>69339-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone orally disintegrating tablets, USP contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-α]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.48. The structural formula is. Risperidone, USP is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.Risperidone orally disintegrating tablets are available in 0.25 mg (white), 0.5 mg (white), 1 mg (white), 2 mg (peach), 3 mg (green), and 4 mg (blue) strengths. Risperidone orally disintegrating tablets contain the following inactive ingredients: amino methacrylate copolymer, aspartame, crospovidone, magnesium stearate, mannitol, lactose monohydrate, peppermint flavor, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol and stearic acid. The 2 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and the 3 mg and 4 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>69339-236-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (69339-236-03) </PackageDescription>
<NDC11Code>69339-0236-03</NDC11Code>
<ProductNDC>69339-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075831</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>BISOPROLOL FUMARATE USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2- (1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2- butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta- blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>69339-237-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (69339-237-03) </PackageDescription>
<NDC11Code>69339-0237-03</NDC11Code>
<ProductNDC>69339-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075831</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>BISOPROLOL FUMARATE USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2- (1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol (E)-2- butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta- blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>0135-0460-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0460-03) / 184.3 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0460-03</NDC11Code>
<ProductNDC>0135-0460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne Pronamel</ProprietaryName>
<ProprietaryNameSuffix>Daily Protection</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate And Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 1.15</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-184-03</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-184-03) </PackageDescription>
<NDC11Code>16714-0184-03</NDC11Code>
<ProductNDC>16714-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070725</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: : 1 Major depressive disorder (MDD) , 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD) , 4 Social anxiety disorder (SAD) , 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.Inactive ingredients consist of dibasic calcium phosphate dihydrate, lactose monohydrate, sodium starch glycolate, dibasic calcium phosphate anhydrous, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition to this, 10 mg tablet contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake. 20 mg and 40 mg tablets contain D&C Red #30 Aluminum Lake. 30 mg tablet contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>24236-184-03</NDCCode>
<PackageDescription>20 TABLET in 1 VIAL (24236-184-03)</PackageDescription>
<NDC11Code>24236-0184-03</NDC11Code>
<ProductNDC>24236-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-03-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>49035-184-03</NDCCode>
<PackageDescription>833 mL in 1 BOTTLE, PLASTIC (49035-184-03) </PackageDescription>
<NDC11Code>49035-0184-03</NDC11Code>
<ProductNDC>49035-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Everyday Clean 2 In 1 Dandruff</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54340-184-03</NDCCode>
<PackageDescription>8 BOTTLE, PUMP in 1 CARTON (54340-184-03) / 296 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>54340-0184-03</NDC11Code>
<ProductNDC>54340-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Foaming Antibacterial Defense Coconut Water</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwasing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62362-184-03</NDCCode>
<PackageDescription>1 PACKAGE in 1 POUCH (62362-184-03) > 2 mL in 1 PACKAGE (62362-184-07)</PackageDescription>
<NDC11Code>62362-0184-03</NDC11Code>
<ProductNDC>62362-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neova Day Therapy</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>PhotoMedex, Inc.</LabelerName>
<SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE</SubstanceName>
<StrengthNumber>7; 6; 5; 3</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63545-184-03</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (63545-184-03) </PackageDescription>
<NDC11Code>63545-0184-03</NDC11Code>
<ProductNDC>63545-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Bromatum</ProprietaryName>
<NonProprietaryName>Arsenicum Bromatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-184-03</NDCCode>
<PackageDescription>15 kg in 1 CANISTER (64220-184-03) </PackageDescription>
<NDC11Code>64220-0184-03</NDC11Code>
<ProductNDC>64220-184</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140923</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-06-23</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64380-184-03</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-03) </PackageDescription>
<NDC11Code>64380-0184-03</NDC11Code>
<ProductNDC>64380-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: : 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING].</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20oC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains Titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>64980-184-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-184-03)</PackageDescription>
<NDC11Code>64980-0184-03</NDC11Code>
<ProductNDC>64980-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202545</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>66506-184-03</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (66506-184-03) / 20 g in 1 TUBE (66506-184-04) </PackageDescription>
<NDC11Code>66506-0184-03</NDC11Code>
<ProductNDC>66506-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cheezheng Pain Relief Cream</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Tibet Cheezheng Tibetan Medicine Co. Ltd</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joint associated with. arthritis strains simple backache sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-184-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-184-03) </PackageDescription>
<NDC11Code>68428-0184-03</NDC11Code>
<ProductNDC>68428-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Agaricus Muscarius</ProprietaryName>
<NonProprietaryName>Amanita Muscaria Var. Muscaria</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>