{
"NDC": [
{
"NDCCode": "0781-1818-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1818-05)",
"NDC11Code": "00781-1818-05",
"ProductNDC": "0781-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19811019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018569",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-02-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0781-1818-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-1818-01) ",
"NDC11Code": "00781-1818-01",
"ProductNDC": "0781-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19811019",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018569",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19811019",
"EndMarketingDatePackage": "20210831",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1818-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0781-1818-10) ",
"NDC11Code": "00781-1818-10",
"ProductNDC": "0781-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19811019",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018569",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19811019",
"EndMarketingDatePackage": "20210831",
"SamplePackage": "N"
},
{
"NDCCode": "67296-1818-5",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (67296-1818-5) ",
"NDC11Code": "67296-1818-05",
"ProductNDC": "67296-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tivicay",
"NonProprietaryName": "Dolutegravir Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204790",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "DOLUTEGRAVIR SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130813",
"SamplePackage": "N",
"IndicationAndUsage": "‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve)aged at least 4 weeks and weighing at least 3 kg [ see Microbiology (12.4)]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.",
"Description": "TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R,12a S)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H-pyrido[1',2':4,5]pyrazino[2,1- b][1,3]oxazin-7-olate. The empirical formula is C 20H 18F 2N 3NaO 5 and the molecular weight is 441.36 g per mol. It has the following structural formula:. Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Each film-coated tablet of TIVICAY for oral administration contains 10.5, 26.3, or 52.6 mg of dolutegravir sodium, which is equivalent to 10, 25, or 50 mg dolutegravir free acid, respectively, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. Each TIVICAY PD tablet for oral suspension contains 5.26 mg of dolutegravir sodium which is equivalent to 5 mg dolutegravir free acid and the following inactive ingredients: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "68071-1818-5",
"PackageDescription": "1 mL in 1 BOX (68071-1818-5) ",
"NDC11Code": "68071-1818-05",
"ProductNDC": "68071-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20040914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076553",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "70470-1818-5",
"PackageDescription": "50 mL in 1 BOTTLE (70470-1818-5)",
"NDC11Code": "70470-1818-05",
"ProductNDC": "70470-1818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stretch Marks Remover",
"ProprietaryNameSuffix": "Stretch Marks Remover",
"NonProprietaryName": "Cocoa Butter",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "PHYTOPIA CO., LTD.",
"SubstanceName": "COCOA BUTTER",
"StrengthNumber": "3.2",
"StrengthUnit": "mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions. Apply on skin and gentlely massage around abdomen."
},
{
"NDCCode": "71335-1818-5",
"PackageDescription": "15 TABLET in 1 BOTTLE (71335-1818-5) ",
"NDC11Code": "71335-1818-05",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210504",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "0527-1818-43",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0527-1818-43) / .1 mL in 1 BLISTER PACK",
"NDC11Code": "00527-1818-43",
"ProductNDC": "0527-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20160219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204841",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "SUMATRIPTAN",
"StrengthNumber": "5",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160219",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan nasal spray, USP is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan nasal spray, USP have not been established for cluster headache.",
"Description": "Sumatriptan nasal spray, USP contains sumatriptan, a selective 5-HT1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure. The empirical formula is C14H21N3O2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan nasal spray, USP contains 5 or 20 mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing purified water USP, sulfuric acid NF, sodium hydroxide NF, monobasic potassium phosphate NF, and anhydrous dibasic sodium phosphate USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg sumatriptan nasal spray, USP, respectively."
},
{
"NDCCode": "55154-1818-7",
"PackageDescription": "14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55154-1818-7)",
"NDC11Code": "55154-1818-07",
"ProductNDC": "55154-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Cardinal Health",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "71335-1818-0",
"PackageDescription": "40 TABLET in 1 BOTTLE (71335-1818-0) ",
"NDC11Code": "71335-1818-00",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241007",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-1",
"PackageDescription": "6 TABLET in 1 BOTTLE (71335-1818-1) ",
"NDC11Code": "71335-1818-01",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241007",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (71335-1818-2) ",
"NDC11Code": "71335-1818-02",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210420",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1818-3) ",
"NDC11Code": "71335-1818-03",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-4",
"PackageDescription": "84 TABLET in 1 BOTTLE (71335-1818-4) ",
"NDC11Code": "71335-1818-04",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241007",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-6",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-1818-6) ",
"NDC11Code": "71335-1818-06",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241007",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-7",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-1818-7) ",
"NDC11Code": "71335-1818-07",
"ProductNDC": "71335-1818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210325",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-8",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1818-8) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "71335-1818-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1818-9) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Bryant Ranch Prepack",
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"LastUpdate": "2026-05-15",
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"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "0378-0781-05",
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{
"NDCCode": "0781-1008-05",
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{
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{
"NDCCode": "0781-1032-05",
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{
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{
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{
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"SamplePackage": "N"
},
{
"NDCCode": "0781-1048-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0781-1048-05) ",
"NDC11Code": "00781-1048-05",
"ProductNDC": "0781-1048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881208",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089685",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19881208",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1061-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1061-05) ",
"NDC11Code": "00781-1061-05",
"ProductNDC": "0781-1061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951229",
"EndMarketingDate": "20270319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074112",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951229",
"EndMarketingDatePackage": "20270319",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake."
},
{
"NDCCode": "0781-1077-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1077-05) ",
"NDC11Code": "00781-1077-05",
"ProductNDC": "0781-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951229",
"EndMarketingDate": "20270319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074112",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951229",
"EndMarketingDatePackage": "20270319",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake."
},
{
"NDCCode": "0781-1078-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1078-05)",
"NDC11Code": "00781-1078-05",
"ProductNDC": "0781-1078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074052",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-07-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0781-1079-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1079-05) ",
"NDC11Code": "00781-1079-05",
"ProductNDC": "0781-1079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951229",
"EndMarketingDate": "20270319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074112",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951229",
"EndMarketingDatePackage": "20270319",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0781-1818-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1818-05)</PackageDescription>
<NDC11Code>00781-1818-05</NDC11Code>
<ProductNDC>0781-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018569</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-1818-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-1818-01) </PackageDescription>
<NDC11Code>00781-1818-01</NDC11Code>
<ProductNDC>0781-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811019</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018569</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19811019</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1818-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0781-1818-10) </PackageDescription>
<NDC11Code>00781-1818-10</NDC11Code>
<ProductNDC>0781-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811019</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018569</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19811019</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67296-1818-5</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (67296-1818-5) </PackageDescription>
<NDC11Code>67296-1818-05</NDC11Code>
<ProductNDC>67296-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tivicay</ProprietaryName>
<NonProprietaryName>Dolutegravir Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204790</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>DOLUTEGRAVIR SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>‑ TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑ 1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve)aged at least 4 weeks and weighing at least 3 kg [ see Microbiology (12.4)]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.</IndicationAndUsage>
<Description>TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R,12a S)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H-pyrido[1',2':4,5]pyrazino[2,1- b][1,3]oxazin-7-olate. The empirical formula is C 20H 18F 2N 3NaO 5 and the molecular weight is 441.36 g per mol. It has the following structural formula:. Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Each film-coated tablet of TIVICAY for oral administration contains 10.5, 26.3, or 52.6 mg of dolutegravir sodium, which is equivalent to 10, 25, or 50 mg dolutegravir free acid, respectively, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. Each TIVICAY PD tablet for oral suspension contains 5.26 mg of dolutegravir sodium which is equivalent to 5 mg dolutegravir free acid and the following inactive ingredients: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1818-5</NDCCode>
<PackageDescription>1 mL in 1 BOX (68071-1818-5) </PackageDescription>
<NDC11Code>68071-1818-05</NDC11Code>
<ProductNDC>68071-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20040914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076553</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70470-1818-5</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (70470-1818-5)</PackageDescription>
<NDC11Code>70470-1818-05</NDC11Code>
<ProductNDC>70470-1818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stretch Marks Remover</ProprietaryName>
<ProprietaryNameSuffix>Stretch Marks Remover</ProprietaryNameSuffix>
<NonProprietaryName>Cocoa Butter</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>PHYTOPIA CO., LTD.</LabelerName>
<SubstanceName>COCOA BUTTER</SubstanceName>
<StrengthNumber>3.2</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Apply on skin and gentlely massage around abdomen.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1818-5</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (71335-1818-5) </PackageDescription>
<NDC11Code>71335-1818-05</NDC11Code>
<ProductNDC>71335-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211610</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0527-1818-43</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0527-1818-43) / .1 mL in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00527-1818-43</NDC11Code>
<ProductNDC>0527-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204841</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan nasal spray, USP is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan nasal spray, USP have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan nasal spray, USP contains sumatriptan, a selective 5-HT1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure. The empirical formula is C14H21N3O2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan nasal spray, USP contains 5 or 20 mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing purified water USP, sulfuric acid NF, sodium hydroxide NF, monobasic potassium phosphate NF, and anhydrous dibasic sodium phosphate USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg sumatriptan nasal spray, USP, respectively.</Description>
</NDC>
<NDC>
<NDCCode>55154-1818-7</NDCCode>
<PackageDescription>14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55154-1818-7)</PackageDescription>
<NDC11Code>55154-1818-07</NDC11Code>
<ProductNDC>55154-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
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<PackageDescription>40 TABLET in 1 BOTTLE (71335-1818-0) </PackageDescription>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
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<LastUpdate>2026-05-15</LastUpdate>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<DEASchedule>CIII</DEASchedule>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
</NDC>
<NDC>
<NDCCode>71335-1818-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1818-9) </PackageDescription>
<NDC11Code>71335-1818-09</NDC11Code>
<ProductNDC>71335-1818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211610</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). · Have not been tolerated, or are not expected to be tolerated. · Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0378-0781-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-05) </PackageDescription>
<NDC11Code>00378-0781-05</NDC11Code>
<ProductNDC>0378-0781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077081</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1008-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1008-05) </PackageDescription>
<NDC11Code>00781-1008-05</NDC11Code>
<ProductNDC>0781-1008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880617</StartMarketingDate>
<EndMarketingDate>20201130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072011</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880617</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1030-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1030-05) </PackageDescription>
<NDC11Code>00781-1030-05</NDC11Code>
<ProductNDC>0781-1030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085785</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1032-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1032-05) </PackageDescription>
<NDC11Code>00781-1032-05</NDC11Code>
<ProductNDC>0781-1032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085786</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1034-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1034-05) </PackageDescription>
<NDC11Code>00781-1034-05</NDC11Code>
<ProductNDC>0781-1034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085789</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1036-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1036-05) </PackageDescription>
<NDC11Code>00781-1036-05</NDC11Code>
<ProductNDC>0781-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trifluoperazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Trifluoperazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085788</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRIFLUOPERAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1047-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1047-05) </PackageDescription>
<NDC11Code>00781-1047-05</NDC11Code>
<ProductNDC>0781-1047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881208</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089685</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19881208</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1048-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0781-1048-05) </PackageDescription>
<NDC11Code>00781-1048-05</NDC11Code>
<ProductNDC>0781-1048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881208</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089685</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19881208</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1061-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1061-05) </PackageDescription>
<NDC11Code>00781-1061-05</NDC11Code>
<ProductNDC>0781-1061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951229</StartMarketingDate>
<EndMarketingDate>20270319</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074112</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951229</StartMarketingDatePackage>
<EndMarketingDatePackage>20270319</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-1077-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1077-05) </PackageDescription>
<NDC11Code>00781-1077-05</NDC11Code>
<ProductNDC>0781-1077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951229</StartMarketingDate>
<EndMarketingDate>20270319</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074112</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951229</StartMarketingDatePackage>
<EndMarketingDatePackage>20270319</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-1078-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1078-05)</PackageDescription>
<NDC11Code>00781-1078-05</NDC11Code>
<ProductNDC>0781-1078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074052</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-1079-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1079-05) </PackageDescription>
<NDC11Code>00781-1079-05</NDC11Code>
<ProductNDC>0781-1079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951229</StartMarketingDate>
<EndMarketingDate>20270319</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074112</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951229</StartMarketingDatePackage>
<EndMarketingDatePackage>20270319</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
</NDCList>