{
"NDC": [
{
"NDCCode": "72658-0812-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0812-2) ",
"NDC11Code": "72658-0812-02",
"ProductNDC": "72658-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0812-1",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72658-0812-1) ",
"NDC11Code": "72658-0812-01",
"ProductNDC": "72658-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0812-3",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (72658-0812-3) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "72658-0812-03",
"ProductNDC": "72658-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0812-5",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72658-0812-5) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "72658-0812-05",
"ProductNDC": "72658-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0812-6",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (72658-0812-6) ",
"NDC11Code": "72658-0812-06",
"ProductNDC": "72658-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "11822-0812-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (11822-0812-2) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "11822-0812-02",
"ProductNDC": "11822-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930402",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930402",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesbackachethe common coldtoothacheminor pain of arthritispremenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "11822-0812-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (11822-0812-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11822-0812-03",
"ProductNDC": "11822-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930402",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19930402",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0812-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0812-2) ",
"NDC11Code": "37662-0812-02",
"ProductNDC": "37662-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indium Metallicum",
"NonProprietaryName": "Indium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220711",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "INDIUM",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220711",
"SamplePackage": "N"
},
{
"NDCCode": "39892-0812-2",
"PackageDescription": "500 POUCH in 1 CASE (39892-0812-2) / 6 g in 1 POUCH",
"NDC11Code": "39892-0812-02",
"ProductNDC": "39892-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medichoice Pvp",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "O&M HALYARD, INC.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170829",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "39892-0812-3",
"PackageDescription": "10 BOX in 1 CASE (39892-0812-3) / 25 PACKET in 1 BOX / 3 PATCH in 1 PACKET / 2.5 g in 1 PATCH",
"NDC11Code": "39892-0812-03",
"ProductNDC": "39892-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medichoice Pvp",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "O&M HALYARD, INC.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170829",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "50090-0812-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-0812-2)",
"NDC11Code": "50090-0812-02",
"ProductNDC": "50090-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076416",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "69167-0812-9",
"PackageDescription": "1 KIT in 1 CARTON (69167-0812-9) * 2.5 g in 1 PACKAGE * 2.5 g in 1 PACKAGE * 113 g in 1 BOTTLE * 4 g in 1 PACKAGE * 3 g in 1 PACKAGE",
"NDC11Code": "69167-0812-09",
"ProductNDC": "69167-0812",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diclofenac Sodium, Amitriptyline Hydrochloride, Prilocaine Hydrochloride And Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20141215",
"EndMarketingDate": "20150717",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Accumix Pharmaceuticals",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20150717"
},
{
"NDCCode": "71335-0812-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-0812-2) ",
"NDC11Code": "71335-0812-02",
"ProductNDC": "71335-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207029",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180504",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone tablets are indicated in the following conditions.",
"Description": "Hydrocortisone tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215º C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "72658-0808-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0808-2) ",
"NDC11Code": "72658-0808-02",
"ProductNDC": "72658-0808",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0809-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0809-2) ",
"NDC11Code": "72658-0809-02",
"ProductNDC": "72658-0809",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0810-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0810-2) ",
"NDC11Code": "72658-0810-02",
"ProductNDC": "72658-0810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0811-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0811-2) ",
"NDC11Code": "72658-0811-02",
"ProductNDC": "72658-0811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0813-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0813-2) ",
"NDC11Code": "72658-0813-02",
"ProductNDC": "72658-0813",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0814-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0814-2) ",
"NDC11Code": "72658-0814-02",
"ProductNDC": "72658-0814",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-0849-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (72658-0849-2) ",
"NDC11Code": "72658-0849-02",
"ProductNDC": "72658-0849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "72658-1253-2",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1253-2) ",
"NDC11Code": "72658-1253-02",
"ProductNDC": "72658-1253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218755",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251002",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "72658-1254-2",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2) ",
"NDC11Code": "72658-1254-02",
"ProductNDC": "72658-1254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218755",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251002",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "72658-1255-2",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1255-2) ",
"NDC11Code": "72658-1255-02",
"ProductNDC": "72658-1255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218755",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251002",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "72658-1256-2",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1256-2) ",
"NDC11Code": "72658-1256-02",
"ProductNDC": "72658-1256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218755",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251002",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "72658-1879-2",
"PackageDescription": "10 VIAL in 1 BOX (72658-1879-2) / 10 mL in 1 VIAL (72658-1879-1) ",
"NDC11Code": "72658-1879-02",
"ProductNDC": "72658-1879",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Chloride",
"NonProprietaryName": "Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217463",
"LabelerName": "Eskayef Pharmaceuticals Limited",
"SubstanceName": "CALCIUM CHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use. The safety and effectiveness of calcium chloride injection for long-term use has not been established.",
"Description": "10% calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca ++and Cl -) in water for injection. It is provided in a 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl 2·2H 2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [seeWarnings and Precautions (5.2)] ."
},
{
"NDCCode": "0054-0812-21",
"PackageDescription": "60 TABLET in 1 CONTAINER (0054-0812-21) ",
"NDC11Code": "00054-0812-21",
"ProductNDC": "0054-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrazinamide",
"NonProprietaryName": "Pyrazinamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081319",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "PYRAZINAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240830",
"SamplePackage": "N",
"IndicationAndUsage": "Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4). (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.). (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4.",
"Description": "Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid."
},
{
"NDCCode": "0054-0812-22",
"PackageDescription": "90 TABLET in 1 CONTAINER (0054-0812-22) ",
"NDC11Code": "00054-0812-22",
"ProductNDC": "0054-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrazinamide",
"NonProprietaryName": "Pyrazinamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240830",
"MarketingCategoryName": "ANDA",
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"Description": "Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid."
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{
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"Description": "Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid."
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"Description": "TOSYMRA contains sumatriptan, a selective 5-HT 1B/1Dreceptor agonist. Sumatriptan is chemically designated as 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]- N-methylmethanesulfonamide, and it has the following structure:. The empirical formula is C 14H 21N 3O 2S, representing a molecular weight of 295.40. Sumatriptan is a white to pale yellow powder that is very slightly soluble in water. TOSYMRA nasal spray is a clear, pale yellow to yellow colored liquid. Each 100 uL of TOSYMRA contains 10 mg of sumatriptan in single-dose aqueous buffered solution containing citric acid monohydrate, n-Dodecyl beta-D-maltoside, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic anhydrous in water for injection. The pH range of solution is approximately 5.0 to 6.0 and the osmolality is between 270 to 330 mOsmol."
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<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
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<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
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<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
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<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>O&M HALYARD, INC.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>39892-0812-3</NDCCode>
<PackageDescription>10 BOX in 1 CASE (39892-0812-3) / 25 PACKET in 1 BOX / 3 PATCH in 1 PACKET / 2.5 g in 1 PATCH</PackageDescription>
<NDC11Code>39892-0812-03</NDC11Code>
<ProductNDC>39892-0812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medichoice Pvp</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>O&M HALYARD, INC.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0812-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-0812-2)</PackageDescription>
<NDC11Code>50090-0812-02</NDC11Code>
<ProductNDC>50090-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076416</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>69167-0812-9</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69167-0812-9) * 2.5 g in 1 PACKAGE * 2.5 g in 1 PACKAGE * 113 g in 1 BOTTLE * 4 g in 1 PACKAGE * 3 g in 1 PACKAGE</PackageDescription>
<NDC11Code>69167-0812-09</NDC11Code>
<ProductNDC>69167-0812</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Diclofenac Sodium, Amitriptyline Hydrochloride, Prilocaine Hydrochloride And Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20141215</StartMarketingDate>
<EndMarketingDate>20150717</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Accumix Pharmaceuticals</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20150717</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71335-0812-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-0812-2) </PackageDescription>
<NDC11Code>71335-0812-02</NDC11Code>
<ProductNDC>71335-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207029</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>Hydrocortisone tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215º C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>72658-0808-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0808-2) </PackageDescription>
<NDC11Code>72658-0808-02</NDC11Code>
<ProductNDC>72658-0808</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0809-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0809-2) </PackageDescription>
<NDC11Code>72658-0809-02</NDC11Code>
<ProductNDC>72658-0809</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0810-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0810-2) </PackageDescription>
<NDC11Code>72658-0810-02</NDC11Code>
<ProductNDC>72658-0810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0811-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0811-2) </PackageDescription>
<NDC11Code>72658-0811-02</NDC11Code>
<ProductNDC>72658-0811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0813-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0813-2) </PackageDescription>
<NDC11Code>72658-0813-02</NDC11Code>
<ProductNDC>72658-0813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0814-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0814-2) </PackageDescription>
<NDC11Code>72658-0814-02</NDC11Code>
<ProductNDC>72658-0814</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-0849-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (72658-0849-2) </PackageDescription>
<NDC11Code>72658-0849-02</NDC11Code>
<ProductNDC>72658-0849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212988</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-1253-2</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1253-2) </PackageDescription>
<NDC11Code>72658-1253-02</NDC11Code>
<ProductNDC>72658-1253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218755</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-1254-2</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2) </PackageDescription>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218755</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide.</Description>
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<NDC>
<NDCCode>72658-1255-2</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1255-2) </PackageDescription>
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<ProductNDC>72658-1255</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20251002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218755</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-1256-2</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1256-2) </PackageDescription>
<NDC11Code>72658-1256-02</NDC11Code>
<ProductNDC>72658-1256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218755</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72658-1879-2</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (72658-1879-2) / 10 mL in 1 VIAL (72658-1879-1) </PackageDescription>
<NDC11Code>72658-1879-02</NDC11Code>
<ProductNDC>72658-1879</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Chloride</ProprietaryName>
<NonProprietaryName>Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217463</ApplicationNumber>
<LabelerName>Eskayef Pharmaceuticals Limited</LabelerName>
<SubstanceName>CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use. The safety and effectiveness of calcium chloride injection for long-term use has not been established.</IndicationAndUsage>
<Description>10% calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca ++and Cl -) in water for injection. It is provided in a 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl 2·2H 2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [seeWarnings and Precautions (5.2)] .</Description>
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<NDC>
<NDCCode>0054-0812-21</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (0054-0812-21) </PackageDescription>
<NDC11Code>00054-0812-21</NDC11Code>
<ProductNDC>0054-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrazinamide</ProprietaryName>
<NonProprietaryName>Pyrazinamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081319</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>PYRAZINAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4). (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.). (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4.</IndicationAndUsage>
<Description>Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0054-0812-22</NDCCode>
<PackageDescription>90 TABLET in 1 CONTAINER (0054-0812-22) </PackageDescription>
<NDC11Code>00054-0812-22</NDC11Code>
<ProductNDC>0054-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrazinamide</ProprietaryName>
<NonProprietaryName>Pyrazinamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081319</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>PYRAZINAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4). (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.). (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4.</IndicationAndUsage>
<Description>Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0054-0812-25</NDCCode>
<PackageDescription>100 TABLET in 1 CONTAINER (0054-0812-25) </PackageDescription>
<NDC11Code>00054-0812-25</NDC11Code>
<ProductNDC>0054-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrazinamide</ProprietaryName>
<NonProprietaryName>Pyrazinamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081319</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>PYRAZINAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4). (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.). (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4.</IndicationAndUsage>
<Description>Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0054-0812-29</NDCCode>
<PackageDescription>500 TABLET in 1 CONTAINER (0054-0812-29) </PackageDescription>
<NDC11Code>00054-0812-29</NDC11Code>
<ProductNDC>0054-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrazinamide</ProprietaryName>
<NonProprietaryName>Pyrazinamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081319</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>PYRAZINAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4). (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.). (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment). It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4.</IndicationAndUsage>
<Description>Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula. C5H5N3O M.W. 123.11. Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0245-0812-61</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0245-0812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK (0245-0812-89) / .1 mL in 1 BOTTLE, SPRAY (0245-0812-59) </PackageDescription>
<NDC11Code>00245-0812-61</NDC11Code>
<ProductNDC>0245-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tosymra</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190708</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210884</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>SUMATRIPTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.</IndicationAndUsage>
<Description>TOSYMRA contains sumatriptan, a selective 5-HT 1B/1Dreceptor agonist. Sumatriptan is chemically designated as 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]- N-methylmethanesulfonamide, and it has the following structure:. The empirical formula is C 14H 21N 3O 2S, representing a molecular weight of 295.40. Sumatriptan is a white to pale yellow powder that is very slightly soluble in water. TOSYMRA nasal spray is a clear, pale yellow to yellow colored liquid. Each 100 uL of TOSYMRA contains 10 mg of sumatriptan in single-dose aqueous buffered solution containing citric acid monohydrate, n-Dodecyl beta-D-maltoside, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic anhydrous in water for injection. The pH range of solution is approximately 5.0 to 6.0 and the osmolality is between 270 to 330 mOsmol.</Description>
</NDC>
</NDCList>