{
"NDC": [
{
"NDCCode": "73116-225-28",
"PackageDescription": "28 CAPSULE in 1 PACKAGE (73116-225-28) ",
"NDC11Code": "73116-0225-28",
"ProductNDC": "73116-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copiktra",
"NonProprietaryName": "Duvelisib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211155",
"LabelerName": "Secura Bio, Inc",
"SubstanceName": "DUVELISIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N",
"IndicationAndUsage": "COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.",
"Description": "COPIKTRA (duvelisib) is a kinase inhibitor. Duvelisib is a white-to-off-white crystalline solid with the empirical formula C22H17ClN6OH2O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity. Duvelisib contains a single chiral center as (S) enantiomer. Duvelisib is soluble in ethanol and practically insoluble in water. Duvelisib is described chemically as a hydrate of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and has the following chemical structure. COPIKTRA capsules are for oral administration and are supplied as white to off-white opaque and Swedish orange opaque capsules (25 mg, on anhydrous basis) or pink opaque capsules (15 mg, on anhydrous basis), and contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide."
},
{
"NDCCode": "73116-225-56",
"PackageDescription": "56 CAPSULE in 1 PACKAGE (73116-225-56) ",
"NDC11Code": "73116-0225-56",
"ProductNDC": "73116-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copiktra",
"NonProprietaryName": "Duvelisib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211155",
"LabelerName": "Secura Bio, Inc",
"SubstanceName": "DUVELISIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180928",
"SamplePackage": "N",
"IndicationAndUsage": "COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.",
"Description": "COPIKTRA (duvelisib) is a kinase inhibitor. Duvelisib is a white-to-off-white crystalline solid with the empirical formula C22H17ClN6OH2O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity. Duvelisib contains a single chiral center as (S) enantiomer. Duvelisib is soluble in ethanol and practically insoluble in water. Duvelisib is described chemically as a hydrate of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and has the following chemical structure. COPIKTRA capsules are for oral administration and are supplied as white to off-white opaque and Swedish orange opaque capsules (25 mg, on anhydrous basis) or pink opaque capsules (15 mg, on anhydrous basis), and contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide."
},
{
"NDCCode": "73116-115-02",
"PackageDescription": "2 PACKAGE in 1 CARTON (73116-115-02) > 28 BLISTER PACK in 1 PACKAGE (73116-115-03) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "73116-0115-02",
"ProductNDC": "73116-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copiktra",
"NonProprietaryName": "Duvelisib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211155",
"LabelerName": "Secura Bio, Inc.",
"SubstanceName": "DUVELISIB",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N"
},
{
"NDCCode": "73116-125-02",
"PackageDescription": "1 PACKAGE in 1 CARTON (73116-125-02) > 28 BLISTER PACK in 1 PACKAGE (73116-125-04) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "73116-0125-02",
"ProductNDC": "73116-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copiktra",
"NonProprietaryName": "Duvelisib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211155",
"LabelerName": "Secura Bio, Inc.",
"SubstanceName": "DUVELISIB",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N"
},
{
"NDCCode": "73116-215-28",
"PackageDescription": "28 CAPSULE in 1 PACKAGE (73116-215-28) ",
"NDC11Code": "73116-0215-28",
"ProductNDC": "73116-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Copiktra",
"NonProprietaryName": "Duvelisib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211155",
"LabelerName": "Secura Bio, Inc",
"SubstanceName": "DUVELISIB",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N",
"IndicationAndUsage": "COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.",
"Description": "COPIKTRA (duvelisib) is a kinase inhibitor. Duvelisib is a white-to-off-white crystalline solid with the empirical formula C22H17ClN6OH2O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity. Duvelisib contains a single chiral center as (S) enantiomer. Duvelisib is soluble in ethanol and practically insoluble in water. Duvelisib is described chemically as a hydrate of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and has the following chemical structure. COPIKTRA capsules are for oral administration and are supplied as white to off-white opaque and Swedish orange opaque capsules (25 mg, on anhydrous basis) or pink opaque capsules (15 mg, on anhydrous basis), and contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide."
},
{
"NDCCode": "43063-225-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-225-28) ",
"NDC11Code": "43063-0225-28",
"ProductNDC": "43063-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primaquine Phosphate",
"NonProprietaryName": "Primaquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA008316",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PRIMAQUINE PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110422",
"SamplePackage": "N",
"IndicationAndUsage": "Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.",
"Description": "Primaquine phosphate is 8-[(4-amino-1-methylbutyl)amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. Each tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Carnauba Wax, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Polysorbate 80, Pregelatinized Starch, Red Ferric Oxide, Talc, Titanium Dioxide."
},
{
"NDCCode": "51316-225-00",
"PackageDescription": "1 TUBE in 1 BOX (51316-225-00) / 28 g in 1 TUBE",
"NDC11Code": "51316-0225-00",
"ProductNDC": "51316-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoidal With Lidocaine",
"NonProprietaryName": "Glycerin, Lidocaine, Phenylephrine Hydrochloride, White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "CVS PHARMACY, INC",
"SubstanceName": "GLYCERIN; LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE; WHITE PETROLATUM",
"StrengthNumber": "144; 50; 2.5; 150",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220601",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful. temporarily shrinks hemorrhoidal tissue."
},
{
"NDCCode": "55910-225-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-225-64) / 28 g in 1 TUBE",
"NDC11Code": "55910-0225-64",
"ProductNDC": "55910-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rexall Anti Itch",
"ProprietaryNameSuffix": "Maximum Strength Relief",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:. eczema. psoriasis. poison ivy, oak, sumac. insect bites. detergents. jewelry. cosmetics. soaps. seborrheic dermatitis . temporarily relieves external anal and genital itching . other uses of this product should only be under the advice and supervision of a doctor."
},
{
"NDCCode": "58602-730-28",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-730-28) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "58602-0730-28",
"ProductNDC": "58602-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207229",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211229",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothache. temporarily reduces fever."
},
{
"NDCCode": "59676-225-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (59676-225-28) ",
"NDC11Code": "59676-0225-28",
"ProductNDC": "59676-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olysio",
"NonProprietaryName": "Simeprevir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131122",
"EndMarketingDate": "20180525",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205123",
"LabelerName": "Janssen Products LP",
"SubstanceName": "SIMEPREVIR",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131122",
"EndMarketingDatePackage": "20180525",
"SamplePackage": "N"
},
{
"NDCCode": "67046-225-28",
"PackageDescription": "28 CAPSULE in 1 BLISTER PACK (67046-225-28) ",
"NDC11Code": "67046-0225-28",
"ProductNDC": "67046-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090858",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170920",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. 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 –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide."
},
{
"NDCCode": "67751-225-01",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (67751-225-01) / 28 g in 1 BOTTLE",
"NDC11Code": "67751-0225-01",
"ProductNDC": "67751-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gold Bond Medicated Original Strength Body",
"NonProprietaryName": "Menthol",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Navajo Manufacturing Company Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": ".15",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves the pain and itch associated with. ■ minor cuts ■ sunburn ■ insect bites ■ scrapes ■ minor burns ■ minor skin irritations."
},
{
"NDCCode": "70108-225-01",
"PackageDescription": "28 mL in 1 BOTTLE, SPRAY (70108-225-01) ",
"NDC11Code": "70108-0225-01",
"ProductNDC": "70108-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Jurassic World Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "71610-225-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (71610-225-28) ",
"NDC11Code": "71610-0225-28",
"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": "20240412",
"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": "0591-2158-22",
"PackageDescription": "225 g in 1 BOTTLE, PLASTIC (0591-2158-22)",
"NDC11Code": "00591-2158-22",
"ProductNDC": "0591-2158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075570",
"LabelerName": "Watson Laboratories, Inc.",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0603-5449-28",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-28)",
"NDC11Code": "00603-5449-28",
"ProductNDC": "0603-5449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075938",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "10544-101-25",
"PackageDescription": "25 CAPSULE in 1 BOTTLE (10544-101-25)",
"NDC11Code": "10544-0101-25",
"ProductNDC": "10544-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074578",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "10544-102-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (10544-102-25)",
"NDC11Code": "10544-0102-25",
"ProductNDC": "10544-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "10544-102-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (10544-102-40)",
"NDC11Code": "10544-0102-40",
"ProductNDC": "10544-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225."
},
{
"NDCCode": "10544-103-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (10544-103-40)",
"NDC11Code": "10544-0103-40",
"ProductNDC": "10544-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-00",
"PackageDescription": "10 TABLET in 1 BOTTLE (12634-520-00)",
"NDC11Code": "12634-0520-00",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (12634-520-01)",
"NDC11Code": "12634-0520-01",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-09",
"PackageDescription": "35 TABLET in 1 BOTTLE (12634-520-09)",
"NDC11Code": "12634-0520-09",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (12634-520-40)",
"NDC11Code": "12634-0520-40",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-52",
"PackageDescription": "12 TABLET in 1 BLISTER PACK (12634-520-52)",
"NDC11Code": "12634-0520-52",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-54",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (12634-520-54)",
"NDC11Code": "12634-0520-54",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-57",
"PackageDescription": "20 TABLET in 1 BLISTER PACK (12634-520-57)",
"NDC11Code": "12634-0520-57",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
"NDCCode": "12634-520-59",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (12634-520-59)",
"NDC11Code": "12634-0520-59",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"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": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
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"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074556",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ACYCLOVIR",
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"StrengthUnit": "mg/1",
"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]",
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"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
},
{
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"PackageDescription": "10 TABLET in 1 BLISTER PACK (12634-520-61)",
"NDC11Code": "12634-0520-61",
"ProductNDC": "12634-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225."
}
]
}
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<LastUpdate>2026-05-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful. temporarily shrinks hemorrhoidal tissue.</IndicationAndUsage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:. eczema. psoriasis. poison ivy, oak, sumac. insect bites. detergents. jewelry. cosmetics. soaps. seborrheic dermatitis . temporarily relieves external anal and genital itching . other uses of this product should only be under the advice and supervision of a doctor.</IndicationAndUsage>
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<IndicationAndUsage>temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothache. temporarily reduces fever.</IndicationAndUsage>
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<NDC>
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<StartMarketingDate>20131122</StartMarketingDate>
<EndMarketingDate>20180525</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Janssen Products LP</LabelerName>
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<Pharm_Classes>Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<EndMarketingDatePackage>20180525</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<StartMarketingDate>20170920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090858</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. 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 –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67751-225-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (67751-225-01) / 28 g in 1 BOTTLE</PackageDescription>
<NDC11Code>67751-0225-01</NDC11Code>
<ProductNDC>67751-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gold Bond Medicated Original Strength Body</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Navajo Manufacturing Company Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves the pain and itch associated with. ■ minor cuts ■ sunburn ■ insect bites ■ scrapes ■ minor burns ■ minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70108-225-01</NDCCode>
<PackageDescription>28 mL in 1 BOTTLE, SPRAY (70108-225-01) </PackageDescription>
<NDC11Code>70108-0225-01</NDC11Code>
<ProductNDC>70108-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Jurassic World Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-225-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (71610-225-28) </PackageDescription>
<NDC11Code>71610-0225-28</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>20240412</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>0591-2158-22</NDCCode>
<PackageDescription>225 g in 1 BOTTLE, PLASTIC (0591-2158-22)</PackageDescription>
<NDC11Code>00591-2158-22</NDC11Code>
<ProductNDC>0591-2158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075570</ApplicationNumber>
<LabelerName>Watson Laboratories, Inc.</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0603-5449-28</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-28)</PackageDescription>
<NDC11Code>00603-5449-28</NDC11Code>
<ProductNDC>0603-5449</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075938</ApplicationNumber>
<LabelerName>Qualitest Pharmaceuticals</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>10544-101-25</NDCCode>
<PackageDescription>25 CAPSULE in 1 BOTTLE (10544-101-25)</PackageDescription>
<NDC11Code>10544-0101-25</NDC11Code>
<ProductNDC>10544-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074578</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>10544-102-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (10544-102-25)</PackageDescription>
<NDC11Code>10544-0102-25</NDC11Code>
<ProductNDC>10544-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>10544-102-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (10544-102-40)</PackageDescription>
<NDC11Code>10544-0102-40</NDC11Code>
<ProductNDC>10544-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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. C8H11N5O3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>10544-103-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (10544-103-40)</PackageDescription>
<NDC11Code>10544-0103-40</NDC11Code>
<ProductNDC>10544-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. 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]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-00</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (12634-520-00)</PackageDescription>
<NDC11Code>12634-0520-00</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (12634-520-01)</PackageDescription>
<NDC11Code>12634-0520-01</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-09</NDCCode>
<PackageDescription>35 TABLET in 1 BOTTLE (12634-520-09)</PackageDescription>
<NDC11Code>12634-0520-09</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (12634-520-40)</PackageDescription>
<NDC11Code>12634-0520-40</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-52</NDCCode>
<PackageDescription>12 TABLET in 1 BLISTER PACK (12634-520-52)</PackageDescription>
<NDC11Code>12634-0520-52</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-54</NDCCode>
<PackageDescription>14 TABLET in 1 BLISTER PACK (12634-520-54)</PackageDescription>
<NDC11Code>12634-0520-54</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-57</NDCCode>
<PackageDescription>20 TABLET in 1 BLISTER PACK (12634-520-57)</PackageDescription>
<NDC11Code>12634-0520-57</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-59</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (12634-520-59)</PackageDescription>
<NDC11Code>12634-0520-59</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (12634-520-60)</PackageDescription>
<NDC11Code>12634-0520-60</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
<NDC>
<NDCCode>12634-520-61</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (12634-520-61)</PackageDescription>
<NDC11Code>12634-0520-61</NDC11Code>
<ProductNDC>12634-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074556</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</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>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpes viruses. Each capsule, for oral administration, contains 200 mg of acyclovir, USP. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1 Aluminum Lake, FD&C blue No. 2 Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10 Aluminum Lake. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2 Aluminum Lake. Acyclovir, USP is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:. C 8H 11N 5O 3 M.W. 225.</Description>
</NDC>
</NDCList>