{
"NDC": [
{
"NDCCode": "70482-170-61",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61) ",
"NDC11Code": "70482-0170-61",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-085-61",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61) ",
"NDC11Code": "70482-0085-61",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-170-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21) ",
"NDC11Code": "70482-0170-21",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-170-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-60) ",
"NDC11Code": "70482-0170-60",
"ProductNDC": "70482-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "10237-628-61",
"PackageDescription": "1 TUBE in 1 CARTON (10237-628-61) > 170 g in 1 TUBE",
"NDC11Code": "10237-0628-61",
"ProductNDC": "10237-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aim Tartar Control",
"ProprietaryNameSuffix": "Plus Mouthwash And Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20040301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10237-635-61",
"PackageDescription": "1 TUBE in 1 CARTON (10237-635-61) > 170 g in 1 TUBE",
"NDC11Code": "10237-0635-61",
"ProductNDC": "10237-635",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aim Tartar Control",
"ProprietaryNameSuffix": "Plus Mouthwash And Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20040301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "53407-170-61",
"PackageDescription": "1 JAR in 1 BOX (53407-170-61) > 7 mL in 1 JAR",
"NDC11Code": "53407-0170-61",
"ProductNDC": "53407-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sublime Defense Anti-aging Blurring Moisturizer Spf 30",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Terravia, Inc.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "1.5; 6",
"StrengthUnit": "g/60mL; g/60mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn : 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "58980-330-61",
"PackageDescription": "1 TUBE in 1 BOX (58980-330-61) > 170.1 g in 1 TUBE",
"NDC11Code": "58980-0330-61",
"ProductNDC": "58980-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cerisa",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090406",
"MarketingCategoryName": "UNAPPROVED OTHER",
"LabelerName": "Stratus Pharamceuticals, Inc",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-07"
},
{
"NDCCode": "58980-340-61",
"PackageDescription": "1 BOTTLE in 1 BOX (58980-340-61) > 170.3 g in 1 BOTTLE",
"NDC11Code": "58980-0340-61",
"ProductNDC": "58980-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 10 Sulfur 5 Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "RINSE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "10; 5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "65862-170-61",
"PackageDescription": "6000 TABLET in 1 BAG (65862-170-61) ",
"NDC11Code": "65862-0170-61",
"ProductNDC": "65862-170",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"StartMarketingDate": "20071031",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-06-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "31-OCT-07"
},
{
"NDCCode": "71921-170-61",
"PackageDescription": "6 CONTAINER in 1 BOX (71921-170-61) > 1 SPRAY in 1 CONTAINER",
"NDC11Code": "71921-0170-61",
"ProductNDC": "71921-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20210515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208967",
"LabelerName": "Florida Pharmaceutical Products, LLC.",
"SubstanceName": "SUMATRIPTAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210515",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.",
"Description": "Sumatriptan nasal spray contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure:. The empirical formula is C 14H 21N 3O 2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is very slightly soluble in water and in saline. Each sumatriptan nasal spray contains 20 mg of sumatriptan in a 100-MicroL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5 and 20 mg sumatriptan nasal spray, respectively."
},
{
"NDCCode": "70482-085-21",
"PackageDescription": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) ",
"NDC11Code": "70482-0085-21",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "Y",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "70482-085-60",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) ",
"NDC11Code": "70482-0085-60",
"ProductNDC": "70482-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gocovri",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208944",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE",
"StrengthNumber": "68.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N",
"IndicationAndUsage": "GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes.",
"Description": "GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule."
},
{
"NDCCode": "0904-7123-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7123-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7123-61",
"ProductNDC": "0904-7123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2."
},
{
"NDCCode": "0904-7124-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7124-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7124-61",
"ProductNDC": "0904-7124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2."
},
{
"NDCCode": "0904-7125-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7125-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7125-61",
"ProductNDC": "0904-7125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2."
},
{
"NDCCode": "0990-7922-61",
"PackageDescription": "32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG",
"NDC11Code": "00990-7922-61",
"ProductNDC": "0990-7922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016367",
"LabelerName": "ICU Medical, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.",
"Description": "Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "63323-624-61",
"PackageDescription": "50 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06) ",
"NDC11Code": "63323-0624-61",
"ProductNDC": "63323-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207449",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161021",
"SamplePackage": "N",
"IndicationAndUsage": "Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.",
"Description": "5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6H 12O 6 H 2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "70482-075-07",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (70482-075-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "70482-0075-07",
"ProductNDC": "70482-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "129",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180601",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "Y",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "70482-075-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14) ",
"NDC11Code": "70482-0075-14",
"ProductNDC": "70482-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "129",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180601",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "Y",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "70482-075-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-30) ",
"NDC11Code": "70482-0075-30",
"ProductNDC": "70482-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "129",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180601",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "70482-076-07",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (70482-076-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "70482-0076-07",
"ProductNDC": "70482-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "193",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "Y",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "70482-076-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-14) ",
"NDC11Code": "70482-0076-14",
"ProductNDC": "70482-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "193",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "Y",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "70482-076-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-30) ",
"NDC11Code": "70482-0076-30",
"ProductNDC": "70482-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmolex Er",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209410",
"LabelerName": "Adamas Pharma, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "193",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.",
"Description": "OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40."
},
{
"NDCCode": "0002-0152-61",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-0152-61",
"ProductNDC": "0002-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepbound",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217806",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "Y",
"IndicationAndUsage": "ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .",
"Description": "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
},
{
"NDCCode": "0002-1433-61",
"PackageDescription": "2 SYRINGE in 1 CARTON (0002-1433-61) / .5 mL in 1 SYRINGE",
"NDC11Code": "00002-1433-61",
"ProductNDC": "0002-1433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trulicity",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140918",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125469",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141107",
"SamplePackage": "Y",
"IndicationAndUsage": "TRULICITY® is indicated: : 1 As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. .",
"Description": "Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection."
},
{
"NDCCode": "0002-1434-61",
"PackageDescription": "2 SYRINGE in 1 CARTON (0002-1434-61) / .5 mL in 1 SYRINGE",
"NDC11Code": "00002-1434-61",
"ProductNDC": "0002-1434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trulicity",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140918",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125469",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141107",
"SamplePackage": "Y",
"IndicationAndUsage": "TRULICITY® is indicated: : 1 As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. .",
"Description": "Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection."
},
{
"NDCCode": "0002-1436-61",
"PackageDescription": "2 SYRINGE in 1 CARTON (0002-1436-61) / 1 mL in 1 SYRINGE",
"NDC11Code": "00002-1436-61",
"ProductNDC": "0002-1436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emgality",
"NonProprietaryName": "Galcanezumab-gnlm",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761063",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "GALCANEZUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180927",
"SamplePackage": "Y",
"IndicationAndUsage": "EMGALITY® is a calcitonin-gene related peptide antagonist indicated in adults for the: : 1 preventive treatment of migraine. (1.1) , 2 treatment of episodic cluster headache. (1.2) .",
"Description": "Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 147 kDa. EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1 mL single-dose prefilled pen to deliver 120 mg of galcanezumab-gnlm or a 1 mL single-dose prefilled syringe to deliver 100 mg or 120 mg of galcanezumab-gnlm. Each mL of solution contains 100 mg or 120 mg of galcanezumab-gnlm; L-histidine (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80 (0.5 mg); Sodium Chloride (8.8 mg); Water for Injection, USP. The pH range is 5.3 - 6.3."
},
{
"NDCCode": "0002-1445-61",
"PackageDescription": "1 SYRINGE in 1 CARTON (0002-1445-61) / 1 mL in 1 SYRINGE",
"NDC11Code": "00002-1445-61",
"ProductNDC": "0002-1445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taltz",
"NonProprietaryName": "Ixekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125521",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "IXEKIZUMAB",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "Y",
"IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
"Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2."
},
{
"NDCCode": "0002-1506-61",
"PackageDescription": "4 SYRINGE in 1 CARTON (0002-1506-61) / .5 mL in 1 SYRINGE",
"NDC11Code": "00002-1506-61",
"ProductNDC": "0002-1506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mounjaro",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220513",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215866",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220608",
"SamplePackage": "Y",
"IndicationAndUsage": "MOUNJARO® is indicated: : 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. .",
"Description": "MOUNJARO (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a once weekly GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. MOUNJARO is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. MOUNJARO has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
}
]
}
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<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-61) </PackageDescription>
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<ProductNDC>70482-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<NDC>
<NDCCode>70482-085-61</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61) </PackageDescription>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
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<NDC>
<NDCCode>70482-170-21</NDCCode>
<PackageDescription>21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-170-21) </PackageDescription>
<NDC11Code>70482-0170-21</NDC11Code>
<ProductNDC>70482-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
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<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
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<ProprietaryName>Gocovri</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
<NDC>
<NDCCode>10237-628-61</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-628-61) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0628-61</NDC11Code>
<ProductNDC>10237-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aim Tartar Control</ProprietaryName>
<ProprietaryNameSuffix>Plus Mouthwash And Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10237-635-61</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-635-61) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0635-61</NDC11Code>
<ProductNDC>10237-635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aim Tartar Control</ProprietaryName>
<ProprietaryNameSuffix>Plus Mouthwash And Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>53407-170-61</NDCCode>
<PackageDescription>1 JAR in 1 BOX (53407-170-61) > 7 mL in 1 JAR</PackageDescription>
<NDC11Code>53407-0170-61</NDC11Code>
<ProductNDC>53407-170</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sublime Defense Anti-aging Blurring Moisturizer Spf 30</ProprietaryName>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Terravia, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.5; 6</StrengthNumber>
<StrengthUnit>g/60mL; g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn : 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58980-330-61</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (58980-330-61) > 170.1 g in 1 TUBE</PackageDescription>
<NDC11Code>58980-0330-61</NDC11Code>
<ProductNDC>58980-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cerisa</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharamceuticals, Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>58980-340-61</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (58980-340-61) > 170.3 g in 1 BOTTLE</PackageDescription>
<NDC11Code>58980-0340-61</NDC11Code>
<ProductNDC>58980-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 10 Sulfur 5 Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Stratus Pharmaceuticals</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>65862-170-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (65862-170-61) </PackageDescription>
<NDC11Code>65862-0170-61</NDC11Code>
<ProductNDC>65862-170</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20071031</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-06-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-OCT-07</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71921-170-61</NDCCode>
<PackageDescription>6 CONTAINER in 1 BOX (71921-170-61) > 1 SPRAY in 1 CONTAINER</PackageDescription>
<NDC11Code>71921-0170-61</NDC11Code>
<ProductNDC>71921-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208967</ApplicationNumber>
<LabelerName>Florida Pharmaceutical Products, LLC.</LabelerName>
<SubstanceName>SUMATRIPTAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan nasal spray contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure:. The empirical formula is C 14H 21N 3O 2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is very slightly soluble in water and in saline. Each sumatriptan nasal spray contains 20 mg of sumatriptan in a 100-MicroL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5 and 20 mg sumatriptan nasal spray, respectively.</Description>
</NDC>
<NDC>
<NDCCode>70482-085-21</NDCCode>
<PackageDescription>21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) </PackageDescription>
<NDC11Code>70482-0085-21</NDC11Code>
<ProductNDC>70482-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>68.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
<NDC>
<NDCCode>70482-085-60</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) </PackageDescription>
<NDC11Code>70482-0085-60</NDC11Code>
<ProductNDC>70482-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gocovri</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208944</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE</SubstanceName>
<StrengthNumber>68.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GOCOVRI ®is indicated: : 1 For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, 2 As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.</IndicationAndUsage>
<Description>GOCOVRI contains amantadine in an extended-release formulation. The active ingredient in GOCOVRI is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:. The molecular formula is C 10H 17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol. GOCOVRI capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.</Description>
</NDC>
<NDC>
<NDCCode>0904-7123-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7123-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7123-61</NDC11Code>
<ProductNDC>0904-7123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>0904-7124-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7124-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7124-61</NDC11Code>
<ProductNDC>0904-7124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>0904-7125-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7125-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7125-61</NDC11Code>
<ProductNDC>0904-7125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration.The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red.Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>0990-7922-61</NDCCode>
<PackageDescription>32 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7922-61</NDC11Code>
<ProductNDC>0990-7922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016367</ApplicationNumber>
<LabelerName>ICU Medical, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 ∙ H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula. Water for Injection, USP is chemically designated H2O. Dextrose Injection, USP (5% and 10%) solutions are sterile and nonpyrogenic. They are parenteral solutions containing various concentrations of dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose, hydrous 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. Each 100 mL of 10% Dextrose Injection, USP, contains dextrose, hydrous 10 g in water for injection. The caloric value is 340 kcal/L. The osmolarity is 505 mOsmol/L (calc.), which is hypertonic. The pH for both concentrations is 4.3 (range is 3.2 to 6.5). The solutions contain no bacteriostatic, antimicrobial agent or added buffer and each is supplied as single-dose containers. Dextrose is derived from corn. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>63323-624-61</NDCCode>
<PackageDescription>50 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06) </PackageDescription>
<NDC11Code>63323-0624-61</NDC11Code>
<ProductNDC>63323-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207449</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic. The solution pH is 4.3 (3.2 to 6.5). This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 5% Dextrose Injection, USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6H 12O 6 H 2O), a hexose sugar freely soluble in water. It has the following structural formula:. Water for Injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>70482-075-07</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (70482-075-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70482-0075-07</NDC11Code>
<ProductNDC>70482-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>129</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>70482-075-14</NDCCode>
<PackageDescription>14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14) </PackageDescription>
<NDC11Code>70482-0075-14</NDC11Code>
<ProductNDC>70482-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>129</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>70482-075-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-30) </PackageDescription>
<NDC11Code>70482-0075-30</NDC11Code>
<ProductNDC>70482-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>129</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>70482-076-07</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (70482-076-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70482-0076-07</NDC11Code>
<ProductNDC>70482-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>193</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>70482-076-14</NDCCode>
<PackageDescription>14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-14) </PackageDescription>
<NDC11Code>70482-0076-14</NDC11Code>
<ProductNDC>70482-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>193</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>70482-076-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-30) </PackageDescription>
<NDC11Code>70482-0076-30</NDC11Code>
<ProductNDC>70482-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmolex Er</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209410</ApplicationNumber>
<LabelerName>Adamas Pharma, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>193</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OSMOLEX ER is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.</IndicationAndUsage>
<Description>OSMOLEX ER contains amantadine in an extended-release tablet. The active ingredient in OSMOLEX ER is amantadine hydrochloride. The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride, and it has the following structural formula:. The molecular formula is C10H17NHCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and alcohol, and soluble in chloroform. OSMOLEX ER tablets are for oral use. Each tablet contains 129 mg, or 193 mg amantadine (as 160 mg or 240 mg, amantadine hydrochloride, respectively) in an extended-release core and an outer immediate-release layer. Amantadine release from the extended-release core is controlled by an osmotic pump system. Osmotic pump systems consist of a drug core contained within a semipermeable polymer membrane that is permeable to water molecules, but not to the drug, with a laser drilled orifice for drug delivery. Amantadine release is driven by the existence of an osmotic gradient between the contents of the drug core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant after the immediate-release layer dissolves. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell. Inactive ingredients: cellulose acetate, colloidal silicon dioxide, copovidone, D&C Yellow No. 10, FD&C Yellow No. 6, ferrosoferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium chloride, and titanium dioxide. OSMOLEX ER 129 mg tablets also contain lactose monohydrate and triacetin. OSMOLEX ER 193 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>0002-0152-61</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-0152-61</NDC11Code>
<ProductNDC>0002-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepbound</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217806</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
<Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
<NDC>
<NDCCode>0002-1433-61</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-1433-61) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1433-61</NDC11Code>
<ProductNDC>0002-1433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trulicity</ProprietaryName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140918</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125469</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141107</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRULICITY® is indicated: : 1 As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. .</IndicationAndUsage>
<Description>Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0002-1434-61</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-1434-61) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1434-61</NDC11Code>
<ProductNDC>0002-1434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trulicity</ProprietaryName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140918</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125469</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141107</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TRULICITY® is indicated: : 1 As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. .</IndicationAndUsage>
<Description>Dulaglutide is a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons. TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0002-1436-61</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-1436-61) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1436-61</NDC11Code>
<ProductNDC>0002-1436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emgality</ProprietaryName>
<NonProprietaryName>Galcanezumab-gnlm</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761063</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>GALCANEZUMAB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180927</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EMGALITY® is a calcitonin-gene related peptide antagonist indicated in adults for the: : 1 preventive treatment of migraine. (1.1) , 2 treatment of episodic cluster headache. (1.2) .</IndicationAndUsage>
<Description>Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains and has an overall molecular weight of approximately 147 kDa. EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1 mL single-dose prefilled pen to deliver 120 mg of galcanezumab-gnlm or a 1 mL single-dose prefilled syringe to deliver 100 mg or 120 mg of galcanezumab-gnlm. Each mL of solution contains 100 mg or 120 mg of galcanezumab-gnlm; L-histidine (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80 (0.5 mg); Sodium Chloride (8.8 mg); Water for Injection, USP. The pH range is 5.3 - 6.3.</Description>
</NDC>
<NDC>
<NDCCode>0002-1445-61</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-1445-61) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1445-61</NDC11Code>
<ProductNDC>0002-1445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taltz</ProprietaryName>
<NonProprietaryName>Ixekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125521</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>IXEKIZUMAB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .</IndicationAndUsage>
<Description>Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.</Description>
</NDC>
<NDC>
<NDCCode>0002-1506-61</NDCCode>
<PackageDescription>4 SYRINGE in 1 CARTON (0002-1506-61) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1506-61</NDC11Code>
<ProductNDC>0002-1506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mounjaro</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220513</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215866</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220608</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MOUNJARO® is indicated: : 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. .</IndicationAndUsage>
<Description>MOUNJARO (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a once weekly GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. MOUNJARO is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. MOUNJARO has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
</NDCList>