{
"NDC": [
{
"NDCCode": "73408-406-20",
"PackageDescription": "6 CELLO PACK in 1 BOX (73408-406-20) > 6 TABLET, CHEWABLE in 1 CELLO PACK",
"NDC11Code": "73408-0406-20",
"ProductNDC": "73408-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crane Safety Bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20200117",
"EndMarketingDate": "20241129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Crane Safety LLC",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200117",
"EndMarketingDatePackage": "20241129",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching, 9 fullness."
},
{
"NDCCode": "73408-030-71",
"PackageDescription": "20 PACKET in 1 BOX (73408-030-71) / 1.4 mL in 1 PACKET",
"NDC11Code": "73408-0030-71",
"ProductNDC": "73408-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crane Safety Antiseptic",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200117",
"EndMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Crane Safety LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200117",
"EndMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "73408-032-71",
"PackageDescription": "20 PACKET in 1 BOX (73408-032-71) / 1.4 mL in 1 PACKET",
"NDC11Code": "73408-0032-71",
"ProductNDC": "73408-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thompson Antiseptic",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Thompson",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.33",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. First aid to help prevent infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "73408-407-20",
"PackageDescription": "6 CELLO PACK in 1 BOX (73408-407-20) / 6 TABLET, CHEWABLE in 1 CELLO PACK",
"NDC11Code": "73408-0407-20",
"ProductNDC": "73408-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thompson Chewable Bismuth Tabs",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210811",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Thompson Safety LLC",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210811",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching, fullness."
},
{
"NDCCode": "11673-406-20",
"PackageDescription": "200 APPLICATOR in 1 BOX (11673-406-20) > .46 mL in 1 APPLICATOR",
"NDC11Code": "11673-0406-20",
"ProductNDC": "11673-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Alcohol Prep Pad",
"NonProprietaryName": "Antiseptic",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Target Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-406-20",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (14445-406-20) / 20 mL in 1 VIAL, GLASS",
"NDC11Code": "14445-0406-20",
"ProductNDC": "14445-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214301",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220409",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Injection is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "47682-406-20",
"PackageDescription": "6 PACKET in 1 BOX (47682-406-20) / 6 TABLET, CHEWABLE in 1 PACKET (47682-406-69) ",
"NDC11Code": "47682-0406-20",
"ProductNDC": "47682-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Pep-t-med",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. relieves : 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: , 4 heartburn indigestionnauseagasbelchingfullness."
},
{
"NDCCode": "50742-406-20",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50742-406-20) / 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50742-0406-20",
"ProductNDC": "50742-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181029",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207562",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181029",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor., 2 treatment of advanced colorectal cancer.",
"Description": "Oxaliplatin,USP is a platinum-based drug with the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)-O,O'] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP for intravenous use is supplied in a single-dose vial containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. The pH is 4.0 to 7.0. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively. Water for Injection, USP is also present as an inactive ingredient."
},
{
"NDCCode": "52125-406-20",
"PackageDescription": "100 TABLET in 1 VIAL (52125-406-20)",
"NDC11Code": "52125-0406-20",
"ProductNDC": "52125-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "63029-406-20",
"PackageDescription": "20 LOZENGE in 1 BAG (63029-406-20) ",
"NDC11Code": "63029-0406-20",
"ProductNDC": "63029-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Little Remedies",
"ProprietaryNameSuffix": "Sore Throat Pops",
"NonProprietaryName": "Pectin",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Medtech Products Inc.",
"SubstanceName": "PECTIN",
"StrengthNumber": "5.4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat."
},
{
"NDCCode": "63187-406-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (63187-406-20) ",
"NDC11Code": "63187-0406-20",
"ProductNDC": "63187-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040105",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains: 1 Oxycodone hydrochloride, USP ................................................................. 5 mg (equivalent to 4.4815 mg of Oxycodone) Acetaminophen, USP .............................................................................. 325 mg."
},
{
"NDCCode": "66336-406-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (66336-406-20)",
"NDC11Code": "66336-0406-20",
"ProductNDC": "66336-406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040143",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "68196-406-20",
"PackageDescription": "2 BOTTLE in 1 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02) ",
"NDC11Code": "68196-0406-20",
"ProductNDC": "68196-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210375",
"LabelerName": "SAM'S WEST INC",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231027",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "73408-225-02",
"PackageDescription": ".0591 L in 1 BOTTLE, SPRAY (73408-225-02) ",
"NDC11Code": "73408-0225-02",
"ProductNDC": "73408-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crane Safety Burn",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Crane Safety LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/L",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200117",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary pain relief associated with minor burns."
},
{
"NDCCode": "0007-3370-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3370-13) ",
"NDC11Code": "00007-3370-13",
"ProductNDC": "0007-3370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070209",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070209",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3371-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3371-13) ",
"NDC11Code": "00007-3371-13",
"ProductNDC": "0007-3371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070206",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3372-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3372-13) ",
"NDC11Code": "00007-3372-13",
"ProductNDC": "0007-3372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070214",
"EndMarketingDate": "20230531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070214",
"EndMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3373-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3373-13) ",
"NDC11Code": "00007-3373-13",
"ProductNDC": "0007-3373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070220",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070220",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3383-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3383-13) ",
"NDC11Code": "00007-3383-13",
"ProductNDC": "0007-3383",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191101",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191101",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3385-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3385-13) ",
"NDC11Code": "00007-3385-13",
"ProductNDC": "0007-3385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191101",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0007-3387-13",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3387-13) ",
"NDC11Code": "00007-3387-13",
"ProductNDC": "0007-3387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coreg",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191101",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022012",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "0069-5471-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01) ",
"NDC11Code": "00069-5471-02",
"ProductNDC": "0069-5471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cerebyx",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20131028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020450",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131028",
"SamplePackage": "N",
"IndicationAndUsage": "CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "0069-5474-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01) ",
"NDC11Code": "00069-5474-02",
"ProductNDC": "0069-5474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cerebyx",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20131028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020450",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131028",
"SamplePackage": "N",
"IndicationAndUsage": "CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "0115-1248-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) ",
"NDC11Code": "00115-1248-01",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-03",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) ",
"NDC11Code": "00115-1248-03",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-08",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) ",
"NDC11Code": "00115-1248-08",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1248-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10) ",
"NDC11Code": "00115-1248-10",
"ProductNDC": "0115-1248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-01) ",
"NDC11Code": "00115-1249-01",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-03",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-03) ",
"NDC11Code": "00115-1249-03",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0115-1249-08",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-08) ",
"NDC11Code": "00115-1249-08",
"ProductNDC": "0115-1249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 ½ EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>73408-406-20</NDCCode>
<PackageDescription>6 CELLO PACK in 1 BOX (73408-406-20) > 6 TABLET, CHEWABLE in 1 CELLO PACK</PackageDescription>
<NDC11Code>73408-0406-20</NDC11Code>
<ProductNDC>73408-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crane Safety Bismuth</ProprietaryName>
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<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
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<LastUpdate>2024-11-30</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200117</StartMarketingDatePackage>
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<IndicationAndUsage>Temporarily relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching, 9 fullness.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNDC>73408-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
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<EndMarketingDate>20251101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Crane Safety LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200117</StartMarketingDatePackage>
<EndMarketingDatePackage>20251101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73408-032-71</NDCCode>
<PackageDescription>20 PACKET in 1 BOX (73408-032-71) / 1.4 mL in 1 PACKET</PackageDescription>
<NDC11Code>73408-0032-71</NDC11Code>
<ProductNDC>73408-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thompson Antiseptic</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Thompson</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.33</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. First aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73408-407-20</NDCCode>
<PackageDescription>6 CELLO PACK in 1 BOX (73408-407-20) / 6 TABLET, CHEWABLE in 1 CELLO PACK</PackageDescription>
<NDC11Code>73408-0407-20</NDC11Code>
<ProductNDC>73408-407</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thompson Chewable Bismuth Tabs</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210811</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Thompson Safety LLC</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. relieves: 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching, fullness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-406-20</NDCCode>
<PackageDescription>200 APPLICATOR in 1 BOX (11673-406-20) > .46 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>11673-0406-20</NDC11Code>
<ProductNDC>11673-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Alcohol Prep Pad</ProprietaryName>
<NonProprietaryName>Antiseptic</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-406-20</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (14445-406-20) / 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>14445-0406-20</NDC11Code>
<ProductNDC>14445-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214301</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Injection is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>47682-406-20</NDCCode>
<PackageDescription>6 PACKET in 1 BOX (47682-406-20) / 6 TABLET, CHEWABLE in 1 PACKET (47682-406-69) </PackageDescription>
<NDC11Code>47682-0406-20</NDC11Code>
<ProductNDC>47682-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Pep-t-med</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. relieves : 1 traveler's diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: , 4 heartburn indigestionnauseagasbelchingfullness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50742-406-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50742-406-20) / 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50742-0406-20</NDC11Code>
<ProductNDC>50742-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181029</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207562</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181029</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor., 2 treatment of advanced colorectal cancer.</IndicationAndUsage>
<Description>Oxaliplatin,USP is a platinum-based drug with the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)-O,O'] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP for intravenous use is supplied in a single-dose vial containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. The pH is 4.0 to 7.0. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively. Water for Injection, USP is also present as an inactive ingredient.</Description>
</NDC>
<NDC>
<NDCCode>52125-406-20</NDCCode>
<PackageDescription>100 TABLET in 1 VIAL (52125-406-20)</PackageDescription>
<NDC11Code>52125-0406-20</NDC11Code>
<ProductNDC>52125-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>63029-406-20</NDCCode>
<PackageDescription>20 LOZENGE in 1 BAG (63029-406-20) </PackageDescription>
<NDC11Code>63029-0406-20</NDC11Code>
<ProductNDC>63029-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Little Remedies</ProprietaryName>
<ProprietaryNameSuffix>Sore Throat Pops</ProprietaryNameSuffix>
<NonProprietaryName>Pectin</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Medtech Products Inc.</LabelerName>
<SubstanceName>PECTIN</SubstanceName>
<StrengthNumber>5.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-406-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (63187-406-20) </PackageDescription>
<NDC11Code>63187-0406-20</NDC11Code>
<ProductNDC>63187-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040105</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains: 1 Oxycodone hydrochloride, USP ................................................................. 5 mg (equivalent to 4.4815 mg of Oxycodone) Acetaminophen, USP .............................................................................. 325 mg.</Description>
</NDC>
<NDC>
<NDCCode>66336-406-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (66336-406-20)</PackageDescription>
<NDC11Code>66336-0406-20</NDC11Code>
<ProductNDC>66336-406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040143</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-406-20</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02) </PackageDescription>
<NDC11Code>68196-0406-20</NDC11Code>
<ProductNDC>68196-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210375</ApplicationNumber>
<LabelerName>SAM'S WEST INC</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73408-225-02</NDCCode>
<PackageDescription>.0591 L in 1 BOTTLE, SPRAY (73408-225-02) </PackageDescription>
<NDC11Code>73408-0225-02</NDC11Code>
<ProductNDC>73408-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crane Safety Burn</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Crane Safety LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary pain relief associated with minor burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0007-3370-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3370-13) </PackageDescription>
<NDC11Code>00007-3370-13</NDC11Code>
<ProductNDC>0007-3370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070209</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070209</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3371-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3371-13) </PackageDescription>
<NDC11Code>00007-3371-13</NDC11Code>
<ProductNDC>0007-3371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070206</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3372-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3372-13) </PackageDescription>
<NDC11Code>00007-3372-13</NDC11Code>
<ProductNDC>0007-3372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070214</StartMarketingDate>
<EndMarketingDate>20230531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070214</StartMarketingDatePackage>
<EndMarketingDatePackage>20230531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3373-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3373-13) </PackageDescription>
<NDC11Code>00007-3373-13</NDC11Code>
<ProductNDC>0007-3373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070220</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070220</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3383-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3383-13) </PackageDescription>
<NDC11Code>00007-3383-13</NDC11Code>
<ProductNDC>0007-3383</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3385-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3385-13) </PackageDescription>
<NDC11Code>00007-3385-13</NDC11Code>
<ProductNDC>0007-3385</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0007-3387-13</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3387-13) </PackageDescription>
<NDC11Code>00007-3387-13</NDC11Code>
<ProductNDC>0007-3387</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coreg</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022012</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 H2O. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0069-5471-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01) </PackageDescription>
<NDC11Code>00069-5471-02</NDC11Code>
<ProductNDC>0069-5471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cerebyx</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20131028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020450</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>0069-5474-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01) </PackageDescription>
<NDC11Code>00069-5474-02</NDC11Code>
<ProductNDC>0069-5474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cerebyx</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20131028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020450</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) </PackageDescription>
<NDC11Code>00115-1248-01</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-03</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) </PackageDescription>
<NDC11Code>00115-1248-03</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-08</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) </PackageDescription>
<NDC11Code>00115-1248-08</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1248-10</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10) </PackageDescription>
<NDC11Code>00115-1248-10</NDC11Code>
<ProductNDC>0115-1248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1249-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-01) </PackageDescription>
<NDC11Code>00115-1249-01</NDC11Code>
<ProductNDC>0115-1249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1249-03</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-03) </PackageDescription>
<NDC11Code>00115-1249-03</NDC11Code>
<ProductNDC>0115-1249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0115-1249-08</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-08) </PackageDescription>
<NDC11Code>00115-1249-08</NDC11Code>
<ProductNDC>0115-1249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol Phosphate</ProprietaryName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204717</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).</IndicationAndUsage>
<Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO4 &frac12; EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac.</Description>
</NDC>
</NDCList>