{
"NDC": [
{
"NDCCode": "76270-116-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (76270-116-24) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "76270-0116-24",
"ProductNDC": "76270-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Docusate Sodium 50 Mg",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "PuraVation Pharmaceuticals Inc",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "76270-116-20",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (76270-116-20) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "76270-0116-20",
"ProductNDC": "76270-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Docusate Sodium 50 Mg",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "PuraVation Pharmaceuticals Inc",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "76270-101-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (76270-101-24) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "76270-0101-24",
"ProductNDC": "76270-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Gentle Relief",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "PuraVation Pharmaceuticals Inc",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "12546-725-24",
"PackageDescription": "1 KIT in 1 KIT (12546-725-24) * 80 LOZENGE in 1 BAG (12546-109-80) * 80 LOZENGE in 1 BAG (12546-116-80) * 80 LOZENGE in 1 BAG (12546-110-80) ",
"NDC11Code": "12546-0725-24",
"ProductNDC": "12546-725",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Halls",
"ProprietaryNameSuffix": "Variety Pack Mentholyptus Honey Lemon Cherry",
"NonProprietaryName": "Menthol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20260720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Mondelez Global LLC",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260720",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to cold, 2 occasional minor irritation or sore throat."
},
{
"NDCCode": "16714-116-02",
"PackageDescription": "30 POUCH in 1 CARTON (16714-116-02) / 24 h in 1 POUCH (16714-116-01) ",
"NDC11Code": "16714-0116-02",
"ProductNDC": "16714-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206318",
"LabelerName": "Northstar Rx LLC.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer's type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson's disease (PD) (1.2).",
"Description": "Rivastigmine transdermal system contains rivastigmine USP, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino)ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a four-layer laminate containing (1) a foam backing with adhesive layer, (2) a polyester film, (3) an adhesive matrix containing rivastigmine, and (4) a fluoropolymer coated polyester release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Layer 1: Copolymer foam backing with adhesive layer. Layer 2: Polyester Film. Layer 3: Adhesive Matrix. Layer 4: Fluoropolymer coated Release Liner (removed at time of use). The active component of the system is rivastigmine. The remaining components of the system (colloidal silicon dioxide, light mineral oil, polyisobutylene adhesive, copolymer foam and polyester film) are pharmacologically inactive. Additionally, rivastigmine transdermal system is printed with pharmaceutical grade brown ink which contains acrylic polymers, carbon black, ethoxylated 2,4,7,9-tetramethyl 5 decyn-4,7-diol, iron oxide, octylphenoxypolyethoxyethanol, polyethylene glycol, polyethylene wax and polytetrafluoroethylene."
},
{
"NDCCode": "21130-116-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-116-02) > 24 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "21130-0116-02",
"ProductNDC": "21130-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Acid Control",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170120",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091429",
"LabelerName": "Safeway",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170120",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "49354-116-24",
"PackageDescription": "24 TUBE, WITH APPLICATOR in 1 CARTON (49354-116-24) > 30 mL in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "49354-0116-24",
"ProductNDC": "49354-116",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "HK Kolmar Canada, Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "126",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2022-07-14",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-SEP-21"
},
{
"NDCCode": "49738-116-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (49738-116-02) > 24 TABLET in 1 BOTTLE",
"NDC11Code": "49738-0116-02",
"ProductNDC": "49738-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Sense Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078653",
"LabelerName": "Kmart Corporation",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "58602-116-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-116-24) > 118 mL in 1 BOTTLE",
"NDC11Code": "58602-0116-24",
"ProductNDC": "58602-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aurotussin Peak Cold Maximum Strength Cough Plus Chest Congestion Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150810",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "58602-160-37",
"PackageDescription": "1 KIT in 1 CARTON (58602-160-37) * 1 BOTTLE in 1 CARTON (58602-116-24) > 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (58602-159-24) > 118 mL in 1 BOTTLE",
"NDC11Code": "58602-0160-37",
"ProductNDC": "58602-160",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aurotussin Maximum Strength Daytime And Nighttime Cough Relief",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "KIT",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Aurohealth LLC",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160527",
"SamplePackage": "N"
},
{
"NDCCode": "66949-116-24",
"PackageDescription": "15140 mL in 1 CASE (66949-116-24) ",
"NDC11Code": "66949-0116-24",
"ProductNDC": "66949-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Fs Antimicrobial Foaming Hand Cleaner",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060412",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Zep Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060412",
"SamplePackage": "N",
"IndicationAndUsage": "Hand washing to decrease bacteria on the skin. For use in food processing facilities."
},
{
"NDCCode": "67091-116-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (67091-116-24) > 24 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "67091-0116-24",
"ProductNDC": "67091-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Maximum Strength Nighttime",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "WinCo Foods, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20141231",
"SamplePackage": "N"
},
{
"NDCCode": "69517-116-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (69517-116-24) > 24 TABLET in 1 BOTTLE",
"NDC11Code": "69517-0116-24",
"ProductNDC": "69517-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gentle Laxative",
"NonProprietaryName": "Gentle Laxative",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Healthlife of USA",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170531",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6 to 12 hours."
},
{
"NDCCode": "0054-0936-21",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0936-21) ",
"NDC11Code": "00054-0936-21",
"ProductNDC": "0054-0936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA200533",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "0054-0937-21",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0937-21) ",
"NDC11Code": "00054-0937-21",
"ProductNDC": "0054-0937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA200533",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "0054-0938-21",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0938-21) ",
"NDC11Code": "00054-0938-21",
"ProductNDC": "0054-0938",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA200533",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "0054-0939-21",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0939-21) ",
"NDC11Code": "00054-0939-21",
"ProductNDC": "0054-0939",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA200533",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "0054-0940-21",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0940-21) ",
"NDC11Code": "00054-0940-21",
"ProductNDC": "0054-0940",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA200533",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.",
"Description": "Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)."
},
{
"NDCCode": "0054-0942-25",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25) ",
"NDC11Code": "00054-0942-25",
"ProductNDC": "0054-0942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022304",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake."
},
{
"NDCCode": "0054-0943-25",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0943-25) ",
"NDC11Code": "00054-0943-25",
"ProductNDC": "0054-0943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022304",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake."
},
{
"NDCCode": "0054-0945-25",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0945-25) ",
"NDC11Code": "00054-0945-25",
"ProductNDC": "0054-0945",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022304",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake."
},
{
"NDCCode": "10631-116-31",
"PackageDescription": "3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69) ",
"NDC11Code": "10631-0116-31",
"ProductNDC": "10631-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Absorica",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120608",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021951",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120608",
"SamplePackage": "N",
"IndicationAndUsage": "ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment[see Dosage and Administration (2.2)].",
"Description": "ABSORICA. ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems. 10 mg – iron oxide (yellow) and titanium dioxide;. 20 mg – iron oxide (red), and titanium dioxide;. 25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14)], FD&C Yellow #6 and titanium dioxide;. 30 mg – iron oxide (black, red and yellow) and titanium dioxide;. 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;. 40 mg – iron oxide (black, red and yellow) and titanium dioxide. ABSORICA LD. ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems. 8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide. 16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide. 28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide. The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide. The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze. Isotretinoin. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is. ABSORICA meets USP Dissolution Test 3. For ABSORICA LD, FDA approved dissolution test differs from the USP."
},
{
"NDCCode": "11673-635-41",
"PackageDescription": "116 g in 1 CANISTER (11673-635-41) ",
"NDC11Code": "11673-0635-41",
"ProductNDC": "11673-635",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calamine Plus Pramoxine Hcl",
"NonProprietaryName": "Calamine Plus Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Target Corporation",
"SubstanceName": "FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE",
"StrengthNumber": ".345; 2.72; 24.16",
"StrengthUnit": "mg/116g; mg/116g; mg/116g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain and itching associated with: 1 insect bites, 2 rashes, 3 minor skin irritations, 4 minor cuts, 5 dries the oozing and weeping of poison ivy, poison oak and poison sumac."
},
{
"NDCCode": "13668-116-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (13668-116-10) ",
"NDC11Code": "13668-0116-10",
"ProductNDC": "13668-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090528",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101006",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "13668-116-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-116-30) ",
"NDC11Code": "13668-0116-30",
"ProductNDC": "13668-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090528",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101006",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "13668-116-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (13668-116-90) ",
"NDC11Code": "13668-0116-90",
"ProductNDC": "13668-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090528",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
"StrengthNumber": "12.5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101006",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "16571-116-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-116-01) ",
"NDC11Code": "16571-0116-01",
"ProductNDC": "16571-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230719",
"EndMarketingDate": "20260208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217995",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230719",
"EndMarketingDatePackage": "20260208",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-116-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-116-50) ",
"NDC11Code": "16571-0116-50",
"ProductNDC": "16571-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230719",
"EndMarketingDate": "20260208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217995",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230719",
"EndMarketingDatePackage": "20260208",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "21130-116-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-116-71) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "21130-0116-71",
"ProductNDC": "21130-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Acid Control",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091429",
"LabelerName": "Safeway",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-07-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "24510-050-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "24510-0050-01",
"ProductNDC": "24510-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "Collegium Pharmaceutical, Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "N",
"IndicationAndUsage": "NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.",
"Description": "NUCYNTA (tapentadol) tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in NUCYNTA tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake."
}
]
}
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<NDCList>
<NDC>
<NDCCode>76270-116-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76270-116-24) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76270-0116-24</NDC11Code>
<ProductNDC>76270-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Docusate Sodium 50 Mg</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>PuraVation Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>76270-116-20</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76270-116-20) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76270-0116-20</NDC11Code>
<ProductNDC>76270-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Docusate Sodium 50 Mg</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>PuraVation Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>76270-101-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (76270-101-24) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>76270-0101-24</NDC11Code>
<ProductNDC>76270-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Gentle Relief</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>PuraVation Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>12546-725-24</NDCCode>
<PackageDescription>1 KIT in 1 KIT (12546-725-24) * 80 LOZENGE in 1 BAG (12546-109-80) * 80 LOZENGE in 1 BAG (12546-116-80) * 80 LOZENGE in 1 BAG (12546-110-80) </PackageDescription>
<NDC11Code>12546-0725-24</NDC11Code>
<ProductNDC>12546-725</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Halls</ProprietaryName>
<ProprietaryNameSuffix>Variety Pack Mentholyptus Honey Lemon Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Mondelez Global LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to cold, 2 occasional minor irritation or sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-116-02</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (16714-116-02) / 24 h in 1 POUCH (16714-116-01) </PackageDescription>
<NDC11Code>16714-0116-02</NDC11Code>
<ProductNDC>16714-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206318</ApplicationNumber>
<LabelerName>Northstar Rx LLC.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>9.5</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: 1 Mild, moderate, and severe dementia of the Alzheimer's type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson's disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine USP, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino)ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a four-layer laminate containing (1) a foam backing with adhesive layer, (2) a polyester film, (3) an adhesive matrix containing rivastigmine, and (4) a fluoropolymer coated polyester release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System. Layer 1: Copolymer foam backing with adhesive layer. Layer 2: Polyester Film. Layer 3: Adhesive Matrix. Layer 4: Fluoropolymer coated Release Liner (removed at time of use). The active component of the system is rivastigmine. The remaining components of the system (colloidal silicon dioxide, light mineral oil, polyisobutylene adhesive, copolymer foam and polyester film) are pharmacologically inactive. Additionally, rivastigmine transdermal system is printed with pharmaceutical grade brown ink which contains acrylic polymers, carbon black, ethoxylated 2,4,7,9-tetramethyl 5 decyn-4,7-diol, iron oxide, octylphenoxypolyethoxyethanol, polyethylene glycol, polyethylene wax and polytetrafluoroethylene.</Description>
</NDC>
<NDC>
<NDCCode>21130-116-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-116-02) > 24 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0116-02</NDC11Code>
<ProductNDC>21130-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Acid Control</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170120</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091429</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170120</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49354-116-24</NDCCode>
<PackageDescription>24 TUBE, WITH APPLICATOR in 1 CARTON (49354-116-24) > 30 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>49354-0116-24</NDC11Code>
<ProductNDC>49354-116</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>HK Kolmar Canada, Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>126</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-07-14</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-SEP-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49738-116-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49738-116-02) > 24 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>49738-0116-02</NDC11Code>
<ProductNDC>49738-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Sense Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078653</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>58602-116-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58602-116-24) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0116-24</NDC11Code>
<ProductNDC>58602-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aurotussin Peak Cold Maximum Strength Cough Plus Chest Congestion Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>58602-160-37</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58602-160-37) * 1 BOTTLE in 1 CARTON (58602-116-24) > 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (58602-159-24) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0160-37</NDC11Code>
<ProductNDC>58602-160</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aurotussin Maximum Strength Daytime And Nighttime Cough Relief</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66949-116-24</NDCCode>
<PackageDescription>15140 mL in 1 CASE (66949-116-24) </PackageDescription>
<NDC11Code>66949-0116-24</NDC11Code>
<ProductNDC>66949-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zep Fs Antimicrobial Foaming Hand Cleaner</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060412</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Zep Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand washing to decrease bacteria on the skin. For use in food processing facilities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67091-116-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (67091-116-24) > 24 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>67091-0116-24</NDC11Code>
<ProductNDC>67091-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141231</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>WinCo Foods, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69517-116-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69517-116-24) > 24 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69517-0116-24</NDC11Code>
<ProductNDC>69517-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gentle Laxative</ProprietaryName>
<NonProprietaryName>Gentle Laxative</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Healthlife of USA</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-0936-21</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0936-21) </PackageDescription>
<NDC11Code>00054-0936-21</NDC11Code>
<ProductNDC>0054-0936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0054-0937-21</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0937-21) </PackageDescription>
<NDC11Code>00054-0937-21</NDC11Code>
<ProductNDC>0054-0937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0054-0938-21</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0938-21) </PackageDescription>
<NDC11Code>00054-0938-21</NDC11Code>
<ProductNDC>0054-0938</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0054-0939-21</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0939-21) </PackageDescription>
<NDC11Code>00054-0939-21</NDC11Code>
<ProductNDC>0054-0939</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0054-0940-21</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0940-21) </PackageDescription>
<NDC11Code>00054-0940-21</NDC11Code>
<ProductNDC>0054-0940</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol extended-release tablets are indicated for the management of: 1 Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate., 2 Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
<Description>Tapentadol extended-release tablet is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NOHCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0054-0942-25</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25) </PackageDescription>
<NDC11Code>00054-0942-25</NDC11Code>
<ProductNDC>0054-0942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0054-0943-25</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0943-25) </PackageDescription>
<NDC11Code>00054-0943-25</NDC11Code>
<ProductNDC>0054-0943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0054-0945-25</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0945-25) </PackageDescription>
<NDC11Code>00054-0945-25</NDC11Code>
<ProductNDC>0054-0945</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>10631-116-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69) </PackageDescription>
<NDC11Code>10631-0116-31</NDC11Code>
<ProductNDC>10631-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Absorica</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120608</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021951</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment[see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>ABSORICA. ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems. 10 mg – iron oxide (yellow) and titanium dioxide;. 20 mg – iron oxide (red), and titanium dioxide;. 25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14)], FD&C Yellow #6 and titanium dioxide;. 30 mg – iron oxide (black, red and yellow) and titanium dioxide;. 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;. 40 mg – iron oxide (black, red and yellow) and titanium dioxide. ABSORICA LD. ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems. 8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide. 16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide. 28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide. The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide. The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze. Isotretinoin. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is. ABSORICA meets USP Dissolution Test 3. For ABSORICA LD, FDA approved dissolution test differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>11673-635-41</NDCCode>
<PackageDescription>116 g in 1 CANISTER (11673-635-41) </PackageDescription>
<NDC11Code>11673-0635-41</NDC11Code>
<ProductNDC>11673-635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calamine Plus Pramoxine Hcl</ProprietaryName>
<NonProprietaryName>Calamine Plus Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.345; 2.72; 24.16</StrengthNumber>
<StrengthUnit>mg/116g; mg/116g; mg/116g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves pain and itching associated with: 1 insect bites, 2 rashes, 3 minor skin irritations, 4 minor cuts, 5 dries the oozing and weeping of poison ivy, poison oak and poison sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-116-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (13668-116-10) </PackageDescription>
<NDC11Code>13668-0116-10</NDC11Code>
<ProductNDC>13668-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090528</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101006</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>13668-116-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-116-30) </PackageDescription>
<NDC11Code>13668-0116-30</NDC11Code>
<ProductNDC>13668-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090528</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101006</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>13668-116-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (13668-116-90) </PackageDescription>
<NDC11Code>13668-0116-90</NDC11Code>
<ProductNDC>13668-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090528</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>12.5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101006</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>16571-116-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16571-116-01) </PackageDescription>
<NDC11Code>16571-0116-01</NDC11Code>
<ProductNDC>16571-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<EndMarketingDate>20260208</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217995</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<EndMarketingDatePackage>20260208</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-116-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-116-50) </PackageDescription>
<NDC11Code>16571-0116-50</NDC11Code>
<ProductNDC>16571-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<EndMarketingDate>20260208</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217995</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<EndMarketingDatePackage>20260208</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>21130-116-71</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-116-71) > 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0116-71</NDC11Code>
<ProductNDC>21130-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Acid Control</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091429</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24510-050-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24510-0050-01</NDC11Code>
<ProductNDC>24510-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.</IndicationAndUsage>
<Description>NUCYNTA (tapentadol) tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure. The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO∙HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in NUCYNTA tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake.</Description>
</NDC>
</NDCList>