{
"NDC": [
{
"NDCCode": "69097-225-70",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (69097-225-70) ",
"NDC11Code": "69097-0225-70",
"ProductNDC": "69097-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Cipla USA, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840911",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "69097-226-70",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (69097-226-70)",
"NDC11Code": "69097-0226-70",
"ProductNDC": "69097-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Cipla USA, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-03-13",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69097-227-70",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (69097-227-70)",
"NDC11Code": "69097-0227-70",
"ProductNDC": "69097-227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "Cipla USA, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-03-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69097-282-70",
"PackageDescription": "50 TABLET in 1 BOTTLE (69097-282-70) ",
"NDC11Code": "69097-0282-70",
"ProductNDC": "69097-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076890",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120330",
"SamplePackage": "N"
},
{
"NDCCode": "69097-289-70",
"PackageDescription": "50 TABLET in 1 BOTTLE (69097-289-70) ",
"NDC11Code": "69097-0289-70",
"ProductNDC": "69097-289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076890",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120330",
"SamplePackage": "N"
},
{
"NDCCode": "23710-225-70",
"PackageDescription": "70 g in 1 CANISTER (23710-225-70)",
"NDC11Code": "23710-0225-70",
"ProductNDC": "23710-225",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Tersi",
"NonProprietaryName": "Selenium Sulfide",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Quinnova Pharmaceuticals, Inc.",
"SubstanceName": "SELENIUM SULFIDE",
"StrengthNumber": "1.44",
"StrengthUnit": "g/70g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "46122-312-70",
"PackageDescription": "225 TABLET, FILM COATED in 1 BOTTLE (46122-312-70) ",
"NDC11Code": "46122-0312-70",
"ProductNDC": "46122-312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Pain Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151109",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250924",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. muscular aches. backache. minor pain of arthritis. the common cold. toothache. premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "71610-225-70",
"PackageDescription": "120 TABLET in 1 BOTTLE (71610-225-70) ",
"NDC11Code": "71610-0225-70",
"ProductNDC": "71610-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230619",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "72562-225-01",
"PackageDescription": "70 g in 1 TUBE (72562-225-01) ",
"NDC11Code": "72562-0225-01",
"ProductNDC": "72562-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tommie Copper Foot",
"NonProprietaryName": "Dimethicone 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210819",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Tommie Copper, Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210819",
"SamplePackage": "N"
},
{
"NDCCode": "69097-656-38",
"PackageDescription": "1 TUBE in 1 CARTON (69097-656-38) > 15 g in 1 TUBE",
"NDC11Code": "69097-0656-38",
"ProductNDC": "69097-656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211794",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190118",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9- [(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:."
},
{
"NDCCode": "69097-656-40",
"PackageDescription": "1 TUBE in 1 CARTON (69097-656-40) > 30 g in 1 TUBE",
"NDC11Code": "69097-0656-40",
"ProductNDC": "69097-656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211794",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190118",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9- [(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:."
},
{
"NDCCode": "69097-677-02",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-677-02) ",
"NDC11Code": "69097-0677-02",
"ProductNDC": "69097-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "69097-677-05",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (69097-677-05) ",
"NDC11Code": "69097-0677-05",
"ProductNDC": "69097-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "69097-677-12",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-677-12) ",
"NDC11Code": "69097-0677-12",
"ProductNDC": "69097-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "69097-677-21",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (69097-677-21) / 10 CAPSULE in 1 BLISTER PACK (69097-677-19) ",
"NDC11Code": "69097-0677-21",
"ProductNDC": "69097-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "69097-678-02",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-678-02) ",
"NDC11Code": "69097-0678-02",
"ProductNDC": "69097-678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
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"StrengthUnit": "mg/1",
"DEASchedule": "CV",
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"LastUpdate": "2025-12-23",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200110",
"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
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},
{
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "69097-682-12",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (69097-682-12) ",
"NDC11Code": "69097-0682-12",
"ProductNDC": "69097-682",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Cipla USA Inc.",
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"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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
}
]
}
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<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
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<LastUpdate>2019-03-13</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<ProductNDC>69097-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076890</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-289-70</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (69097-289-70) </PackageDescription>
<NDC11Code>69097-0289-70</NDC11Code>
<ProductNDC>69097-289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Cipla USA Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>23710-225-70</NDCCode>
<PackageDescription>70 g in 1 CANISTER (23710-225-70)</PackageDescription>
<NDC11Code>23710-0225-70</NDC11Code>
<ProductNDC>23710-225</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Tersi</ProprietaryName>
<NonProprietaryName>Selenium Sulfide</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Quinnova Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SELENIUM SULFIDE</SubstanceName>
<StrengthNumber>1.44</StrengthNumber>
<StrengthUnit>g/70g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46122-312-70</NDCCode>
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<NDC11Code>46122-0312-70</NDC11Code>
<ProductNDC>46122-312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. muscular aches. backache. minor pain of arthritis. the common cold. toothache. premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
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<NDC>
<NDCCode>71610-225-70</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (71610-225-70) </PackageDescription>
<NDC11Code>71610-0225-70</NDC11Code>
<ProductNDC>71610-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>72562-225-01</NDCCode>
<PackageDescription>70 g in 1 TUBE (72562-225-01) </PackageDescription>
<NDC11Code>72562-0225-01</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tommie Copper Foot</ProprietaryName>
<NonProprietaryName>Dimethicone 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210819</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Tommie Copper, Inc.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-656-38</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69097-656-38) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>69097-0656-38</NDC11Code>
<ProductNDC>69097-656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211794</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9- [(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>69097-656-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69097-656-40) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>69097-0656-40</NDC11Code>
<ProductNDC>69097-656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211794</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9- [(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>69097-677-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-677-02) </PackageDescription>
<NDC11Code>69097-0677-02</NDC11Code>
<ProductNDC>69097-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-677-05</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69097-677-05) </PackageDescription>
<NDC11Code>69097-0677-05</NDC11Code>
<ProductNDC>69097-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-677-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-677-12) </PackageDescription>
<NDC11Code>69097-0677-12</NDC11Code>
<ProductNDC>69097-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-677-21</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (69097-677-21) / 10 CAPSULE in 1 BLISTER PACK (69097-677-19) </PackageDescription>
<NDC11Code>69097-0677-21</NDC11Code>
<ProductNDC>69097-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-678-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-678-02) </PackageDescription>
<NDC11Code>69097-0678-02</NDC11Code>
<ProductNDC>69097-678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-678-05</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69097-678-05) </PackageDescription>
<NDC11Code>69097-0678-05</NDC11Code>
<ProductNDC>69097-678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-678-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-678-12) </PackageDescription>
<NDC11Code>69097-0678-12</NDC11Code>
<ProductNDC>69097-678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-678-21</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (69097-678-21) / 10 CAPSULE in 1 BLISTER PACK (69097-678-19) </PackageDescription>
<NDC11Code>69097-0678-21</NDC11Code>
<ProductNDC>69097-678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-679-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-679-02) </PackageDescription>
<NDC11Code>69097-0679-02</NDC11Code>
<ProductNDC>69097-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-679-05</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69097-679-05) </PackageDescription>
<NDC11Code>69097-0679-05</NDC11Code>
<ProductNDC>69097-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-679-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-679-12) </PackageDescription>
<NDC11Code>69097-0679-12</NDC11Code>
<ProductNDC>69097-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-679-21</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (69097-679-21) / 10 CAPSULE in 1 BLISTER PACK (69097-679-19) </PackageDescription>
<NDC11Code>69097-0679-21</NDC11Code>
<ProductNDC>69097-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-681-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-681-02) </PackageDescription>
<NDC11Code>69097-0681-02</NDC11Code>
<ProductNDC>69097-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-681-05</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69097-681-05) </PackageDescription>
<NDC11Code>69097-0681-05</NDC11Code>
<ProductNDC>69097-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-681-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-681-12) </PackageDescription>
<NDC11Code>69097-0681-12</NDC11Code>
<ProductNDC>69097-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-681-21</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (69097-681-21) / 10 CAPSULE in 1 BLISTER PACK (69097-681-19) </PackageDescription>
<NDC11Code>69097-0681-21</NDC11Code>
<ProductNDC>69097-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-682-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-682-02) </PackageDescription>
<NDC11Code>69097-0682-02</NDC11Code>
<ProductNDC>69097-682</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-682-05</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (69097-682-05) </PackageDescription>
<NDC11Code>69097-0682-05</NDC11Code>
<ProductNDC>69097-682</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-682-12</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (69097-682-12) </PackageDescription>
<NDC11Code>69097-0682-12</NDC11Code>
<ProductNDC>69097-682</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
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