{
"NDC": [
{
"NDCCode": "57664-540-27",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (57664-540-27)",
"NDC11Code": "57664-0540-27",
"ProductNDC": "57664-540",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077499",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-541-27",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (57664-541-27)",
"NDC11Code": "57664-0541-27",
"ProductNDC": "57664-541",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077499",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-540-26",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (57664-540-26)",
"NDC11Code": "57664-0540-26",
"ProductNDC": "57664-540",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077499",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-540-83",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (57664-540-83)",
"NDC11Code": "57664-0540-83",
"ProductNDC": "57664-540",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077499",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-540-88",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (57664-540-88)",
"NDC11Code": "57664-0540-88",
"ProductNDC": "57664-540",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077499",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-058-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-058-88) ",
"NDC11Code": "57664-0058-88",
"ProductNDC": "57664-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levorphanol Tartrate",
"NonProprietaryName": "Levorphanol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213906",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LEVORPHANOL TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240615",
"SamplePackage": "N",
"IndicationAndUsage": "Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Levorphanol tartrate tablets USP, contain levorphanol, an opioid agonist with a molecular formula of C 17H 23NO C 4H 6O 6 2H 2O and molecular weight 443.5. Each milligram of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Levorphanol's chemical name is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17- methylmorphinan 3-ol tartrate (1:1) (Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:. Levorphanol tartrate, USP is a white crystalline powder, soluble in water and ether, but insoluble in chloroform. Levorphanol tartrate tablets, USP, for oral administration, are available in two strengths. 2 mg tablet: white to off-white, flat face beveled edge tablet, bisect scored on one side and debossed with “762” on other side. 3 mg tablet: white to off-white, oval tablet, debossed with “058” on one side. In addition, each tablet contains microcrystalline cellulose, anhydrous lactose, pregelatinized starch, and magnesium stearate."
},
{
"NDCCode": "57664-146-31",
"PackageDescription": "118 mL in 1 BOTTLE (57664-146-31)",
"NDC11Code": "57664-0146-31",
"ProductNDC": "57664-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040891",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-146-34",
"PackageDescription": "473 mL in 1 BOTTLE (57664-146-34)",
"NDC11Code": "57664-0146-34",
"ProductNDC": "57664-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040891",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57664-187-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-187-88) ",
"NDC11Code": "57664-0187-88",
"ProductNDC": "57664-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "57664-223-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-223-88) ",
"NDC11Code": "57664-0223-88",
"ProductNDC": "57664-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "57664-224-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-224-88) ",
"NDC11Code": "57664-0224-88",
"ProductNDC": "57664-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "57664-370-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-370-88) ",
"NDC11Code": "57664-0370-88",
"ProductNDC": "57664-370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "57664-371-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-371-88) ",
"NDC11Code": "57664-0371-88",
"ProductNDC": "57664-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "57664-437-33",
"PackageDescription": "5000 TABLET in 1 BOTTLE (57664-437-33)",
"NDC11Code": "57664-0437-33",
"ProductNDC": "57664-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076363",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "57664-441-33",
"PackageDescription": "5000 TABLET in 1 BOTTLE (57664-441-33)",
"NDC11Code": "57664-0441-33",
"ProductNDC": "57664-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076363",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "57664-499-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-499-18) ",
"NDC11Code": "57664-0499-18",
"ProductNDC": "57664-499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-499-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-499-83) ",
"NDC11Code": "57664-0499-83",
"ProductNDC": "57664-499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-500-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-500-18) ",
"NDC11Code": "57664-0500-18",
"ProductNDC": "57664-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-500-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-500-83) ",
"NDC11Code": "57664-0500-83",
"ProductNDC": "57664-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-501-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-501-18) ",
"NDC11Code": "57664-0501-18",
"ProductNDC": "57664-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-501-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-501-83) ",
"NDC11Code": "57664-0501-83",
"ProductNDC": "57664-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-510-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (57664-510-83) ",
"NDC11Code": "57664-0510-83",
"ProductNDC": "57664-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076541",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040422",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black)."
},
{
"NDCCode": "57664-606-88",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-606-88) ",
"NDC11Code": "57664-0606-88",
"ProductNDC": "57664-606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205135",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57664-607-88",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-607-88) ",
"NDC11Code": "57664-0607-88",
"ProductNDC": "57664-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205135",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "27",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57664-608-88",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88) ",
"NDC11Code": "57664-0608-88",
"ProductNDC": "57664-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205135",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57664-609-88",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-609-88) ",
"NDC11Code": "57664-0609-88",
"ProductNDC": "57664-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205135",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200820",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57664-683-31",
"PackageDescription": "300 mL in 1 BAG (57664-683-31)",
"NDC11Code": "57664-0683-31",
"ProductNDC": "57664-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207354",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-06-27"
},
{
"NDCCode": "57664-687-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18) ",
"NDC11Code": "57664-0687-18",
"ProductNDC": "57664-687",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19870714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089399",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870714",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "57664-687-88",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88) ",
"NDC11Code": "57664-0687-88",
"ProductNDC": "57664-687",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19870714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089399",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870714",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "57664-688-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-18) ",
"NDC11Code": "57664-0688-18",
"ProductNDC": "57664-688",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19870714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089399",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870714",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>57664-540-27</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (57664-540-27)</PackageDescription>
<NDC11Code>57664-0540-27</NDC11Code>
<ProductNDC>57664-540</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077499</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-541-27</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (57664-541-27)</PackageDescription>
<NDC11Code>57664-0541-27</NDC11Code>
<ProductNDC>57664-541</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077499</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-540-26</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (57664-540-26)</PackageDescription>
<NDC11Code>57664-0540-26</NDC11Code>
<ProductNDC>57664-540</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077499</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-540-83</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (57664-540-83)</PackageDescription>
<NDC11Code>57664-0540-83</NDC11Code>
<ProductNDC>57664-540</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077499</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-540-88</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (57664-540-88)</PackageDescription>
<NDC11Code>57664-0540-88</NDC11Code>
<ProductNDC>57664-540</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077499</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-058-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-058-88) </PackageDescription>
<NDC11Code>57664-0058-88</NDC11Code>
<ProductNDC>57664-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levorphanol Tartrate</ProprietaryName>
<NonProprietaryName>Levorphanol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213906</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LEVORPHANOL TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Levorphanol tartrate tablets USP, contain levorphanol, an opioid agonist with a molecular formula of C 17H 23NO C 4H 6O 6 2H 2O and molecular weight 443.5. Each milligram of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Levorphanol's chemical name is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17- methylmorphinan 3-ol tartrate (1:1) (Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:. Levorphanol tartrate, USP is a white crystalline powder, soluble in water and ether, but insoluble in chloroform. Levorphanol tartrate tablets, USP, for oral administration, are available in two strengths. 2 mg tablet: white to off-white, flat face beveled edge tablet, bisect scored on one side and debossed with “762” on other side. 3 mg tablet: white to off-white, oval tablet, debossed with “058” on one side. In addition, each tablet contains microcrystalline cellulose, anhydrous lactose, pregelatinized starch, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>57664-146-31</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (57664-146-31)</PackageDescription>
<NDC11Code>57664-0146-31</NDC11Code>
<ProductNDC>57664-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040891</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-146-34</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (57664-146-34)</PackageDescription>
<NDC11Code>57664-0146-34</NDC11Code>
<ProductNDC>57664-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040891</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-187-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-187-88) </PackageDescription>
<NDC11Code>57664-0187-88</NDC11Code>
<ProductNDC>57664-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>57664-223-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-223-88) </PackageDescription>
<NDC11Code>57664-0223-88</NDC11Code>
<ProductNDC>57664-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>57664-224-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-224-88) </PackageDescription>
<NDC11Code>57664-0224-88</NDC11Code>
<ProductNDC>57664-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>57664-370-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-370-88) </PackageDescription>
<NDC11Code>57664-0370-88</NDC11Code>
<ProductNDC>57664-370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>57664-371-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-371-88) </PackageDescription>
<NDC11Code>57664-0371-88</NDC11Code>
<ProductNDC>57664-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>57664-437-33</NDCCode>
<PackageDescription>5000 TABLET in 1 BOTTLE (57664-437-33)</PackageDescription>
<NDC11Code>57664-0437-33</NDC11Code>
<ProductNDC>57664-437</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076363</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>57664-441-33</NDCCode>
<PackageDescription>5000 TABLET in 1 BOTTLE (57664-441-33)</PackageDescription>
<NDC11Code>57664-0441-33</NDC11Code>
<ProductNDC>57664-441</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076363</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>57664-499-18</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-499-18) </PackageDescription>
<NDC11Code>57664-0499-18</NDC11Code>
<ProductNDC>57664-499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-499-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-499-83) </PackageDescription>
<NDC11Code>57664-0499-83</NDC11Code>
<ProductNDC>57664-499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-500-18</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-500-18) </PackageDescription>
<NDC11Code>57664-0500-18</NDC11Code>
<ProductNDC>57664-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-500-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-500-83) </PackageDescription>
<NDC11Code>57664-0500-83</NDC11Code>
<ProductNDC>57664-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-501-18</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-501-18) </PackageDescription>
<NDC11Code>57664-0501-18</NDC11Code>
<ProductNDC>57664-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-501-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-501-83) </PackageDescription>
<NDC11Code>57664-0501-83</NDC11Code>
<ProductNDC>57664-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-510-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57664-510-83) </PackageDescription>
<NDC11Code>57664-0510-83</NDC11Code>
<ProductNDC>57664-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076541</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro- 2-methylpyrazino [2,1-a] pyrido [2,3-c] [2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine, USP is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, magnesium stearate, pregelatinized starch, and titanium dioxide. The 7.5 mg and 15 mg tablets also contains iron oxide (yellow) and the 30 mg tablets also contains iron oxides (yellow, red and black).</Description>
</NDC>
<NDC>
<NDCCode>57664-606-88</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-606-88) </PackageDescription>
<NDC11Code>57664-0606-88</NDC11Code>
<ProductNDC>57664-606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205135</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57664-607-88</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-607-88) </PackageDescription>
<NDC11Code>57664-0607-88</NDC11Code>
<ProductNDC>57664-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205135</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>27</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57664-608-88</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-608-88) </PackageDescription>
<NDC11Code>57664-0608-88</NDC11Code>
<ProductNDC>57664-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205135</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57664-609-88</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-609-88) </PackageDescription>
<NDC11Code>57664-0609-88</NDC11Code>
<ProductNDC>57664-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205135</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivitydisorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patientsyounger than 6 years of age because they had higher plasma exposure and a higher incidence of adversereactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions(5.7) and Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57664-683-31</NDCCode>
<PackageDescription>300 mL in 1 BAG (57664-683-31)</PackageDescription>
<NDC11Code>57664-0683-31</NDC11Code>
<ProductNDC>57664-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207354</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>57664-687-18</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18) </PackageDescription>
<NDC11Code>57664-0687-18</NDC11Code>
<ProductNDC>57664-687</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089399</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>57664-687-88</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88) </PackageDescription>
<NDC11Code>57664-0687-88</NDC11Code>
<ProductNDC>57664-687</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089399</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>57664-688-18</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-18) </PackageDescription>
<NDC11Code>57664-0688-18</NDC11Code>
<ProductNDC>57664-688</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089399</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl is 3-(10,11-dihydro-5 H-dibenzo [ a,d] cycloheptene-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C 20H 23N ∙ HCl and its structural formula is:. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
</NDCList>