{
"NDC": [
{
"NDCCode": "68462-342-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68462-342-05) ",
"NDC11Code": "68462-0342-05",
"ProductNDC": "68462-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "68462-342-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68462-342-01) ",
"NDC11Code": "68462-0342-01",
"ProductNDC": "68462-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "68462-342-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-342-10) ",
"NDC11Code": "68462-0342-10",
"ProductNDC": "68462-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "13668-342-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-342-05) ",
"NDC11Code": "13668-0342-05",
"ProductNDC": "13668-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203370",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N"
},
{
"NDCCode": "24208-342-05",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (24208-342-05) / 5 mL in 1 BOTTLE, PUMP",
"NDC11Code": "24208-0342-05",
"ProductNDC": "24208-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "19990125",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074830",
"LabelerName": "Bauch & Lomb Incorporated",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990125",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use:Desmopressin nasal spray solution is not indicated for: 1 Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)], Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)].",
"Description": "Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains:ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%."
},
{
"NDCCode": "24338-342-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "24338-0342-05",
"ProductNDC": "24338-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gleostine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251024",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251024",
"SamplePackage": "N",
"IndicationAndUsage": "Gleostine is an alkylating drug indicated for the treatment of patients with: : 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. (1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) .",
"Description": "Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C9H16ClN3O2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is:. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2."
},
{
"NDCCode": "31722-342-05",
"PackageDescription": "12 BOTTLE in 1 CASE (31722-342-05) / 500 TABLET in 1 BOTTLE (31722-342-01) ",
"NDC11Code": "31722-0342-05",
"ProductNDC": "31722-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091305",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250903",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen tablets are indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritits.",
"Description": "Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid ¬soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen tablets, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "41520-342-05",
"PackageDescription": "177 mL in 1 CAN (41520-342-05) ",
"NDC11Code": "41520-0342-05",
"ProductNDC": "41520-342",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Sunscreen Spf 30",
"NonProprietaryName": "Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2% Oxybenzone 4%",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Care One",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5; 2; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180413",
"SamplePackage": "N"
},
{
"NDCCode": "42571-342-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (42571-342-05) ",
"NDC11Code": "42571-0342-05",
"ProductNDC": "42571-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213219",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "49643-342-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-342-05) ",
"NDC11Code": "49643-0342-05",
"ProductNDC": "49643-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Bermuda Grass",
"NonProprietaryName": "Cynodon Dactylon",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19961202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102214",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "CYNODON DACTYLON POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19961202",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.",
"Description": "Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts."
},
{
"NDCCode": "50419-342-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-342-05) > 50 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0342-05",
"ProductNDC": "50419-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20091230",
"EndMarketingDate": "20210103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091230",
"EndMarketingDatePackage": "20210103",
"SamplePackage": "N"
},
{
"NDCCode": "52536-342-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (52536-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "52536-0342-05",
"ProductNDC": "52536-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomustine",
"NonProprietaryName": "Lomustine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017588",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "LOMUSTINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "Lomustine is an alkylating drug indicated for the treatment of patients with: : 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. (1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) .",
"Description": "Lomustine is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C9H16ClN3O2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is:. Lomustine Capsules, USP are supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2."
},
{
"NDCCode": "55111-342-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-342-05) ",
"NDC11Code": "55111-0342-05",
"ProductNDC": "55111-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a white or almost white crystalline powder. Citalopram hydrobromide USP is soluble in methanol and sparingly soluble in water. Citalopram tablets USP, 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg of citalopram base. Citalopram tablets USP, 20 mg and 40 mg are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg of citalopram base. Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose 5 cP, hypromellose 6 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide. Iron oxides are used as coloring agents in the brown (10 mg) and pink (20 mg) tablets."
},
{
"NDCCode": "55150-342-05",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-05) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0342-05",
"ProductNDC": "55150-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212965",
"LabelerName": "Eugia US LLC",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200706",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride injection, USP is indicated for the following. In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1.0%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole-see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection.",
"Description": "Verapamil hydrochloride is a calcium antagonist or slow channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, clear colorless solution and is available in 5 mg/2 mL and 10 mg/4 mL single-dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil hydrochloride, USP and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of solution is between 4.0 and 6.5. Protect contents from light. Verapamil hydrochloride injection, USP vials are sterile. The structural formula of verapamil hydrochloride is given below: The chemical name of verapamil hydrochloride is Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride, USP is white or practically white, crystalline powder. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol, practically insoluble in ether. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "61919-342-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (61919-342-05) ",
"NDC11Code": "61919-0342-05",
"ProductNDC": "61919-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083677",
"LabelerName": "Direct_Rx",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190807",
"SamplePackage": "N"
},
{
"NDCCode": "64950-342-45",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05) ",
"NDC11Code": "64950-0342-45",
"ProductNDC": "64950-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hycodan",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA005213",
"LabelerName": "Genus Lifesciences Inc.",
"SubstanceName": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"StrengthNumber": "1.5; 5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "HYCODAN is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.",
"Description": "HYCODAN tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of HYCODAN contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. HYCODAN tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, pregelatinized starch and stearic acid. HYCODAN oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose."
},
{
"NDCCode": "67645-342-06",
"PackageDescription": "25 BAG in 1 CARTON (67645-342-06) / .454 kg in 1 BAG (67645-342-05) ",
"NDC11Code": "67645-0342-06",
"ProductNDC": "67645-342",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "78",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "68428-342-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-342-05) ",
"NDC11Code": "68428-0342-05",
"ProductNDC": "68428-342",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cornus Florida",
"NonProprietaryName": "Cornus Florida Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CORNUS FLORIDA BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68682-342-05",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMP",
"NDC11Code": "68682-0342-05",
"ProductNDC": "68682-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20250601",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074830",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250601",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use:Desmopressin nasal spray solution is not indicated for: 1 Treatment of nephrogenic diabetes insipidus,, 2 Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)],, 3 Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)],, 4 Use in patients with an impaired level of consciousness,, 5 Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths(3)].",
"Description": "Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains:ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%."
},
{
"NDCCode": "76282-342-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (76282-342-05) ",
"NDC11Code": "76282-0342-05",
"ProductNDC": "76282-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091305",
"LabelerName": "Exelan Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. It has the following structural formula. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "84756-342-05",
"PackageDescription": "100 g in 1 BOX (84756-342-05) ",
"NDC11Code": "84756-0342-05",
"ProductNDC": "84756-342",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-wrinkle Firm Lift Night Cream",
"NonProprietaryName": "Anti-wrinkle Firm Lift Night Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Guangzhou�GebianTrading�Co�Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241118",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "68462-108-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-108-05) ",
"NDC11Code": "68462-0108-05",
"ProductNDC": "68462-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077627",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
},
{
"NDCCode": "68462-109-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-109-05) ",
"NDC11Code": "68462-0109-05",
"ProductNDC": "68462-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077627",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
},
{
"NDCCode": "68462-110-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05) ",
"NDC11Code": "68462-0110-05",
"ProductNDC": "68462-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077627",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color."
},
{
"NDCCode": "68462-113-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-113-05)",
"NDC11Code": "68462-0113-05",
"ProductNDC": "68462-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077654",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68462-114-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-114-05)",
"NDC11Code": "68462-0114-05",
"ProductNDC": "68462-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077654",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68462-115-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-115-05)",
"NDC11Code": "68462-0115-05",
"ProductNDC": "68462-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077654",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68462-120-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (68462-120-05) ",
"NDC11Code": "68462-0120-05",
"ProductNDC": "68462-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216357",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221216",
"SamplePackage": "N",
"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-121-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (68462-121-05) ",
"NDC11Code": "68462-0121-05",
"ProductNDC": "68462-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216357",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221216",
"SamplePackage": "N",
"IndicationAndUsage": "I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).",
"Description": "Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-126-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68462-126-05) ",
"NDC11Code": "68462-0126-05",
"ProductNDC": "68462-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060401",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 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 Tablets, USP is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24 g/mol. The structural formula of gabapentin, USP is. Gabapentin, USP 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 Tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, opadry white, polyethylene glycol and talc. Additionally, the coating material opadry white contains hypromellose, macrogol, polysorbate 80 and titanium dioxide."
}
]
}
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<NDCList>
<NDC>
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<NDC11Code>68462-0342-05</NDC11Code>
<ProductNDC>68462-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>68462-342-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68462-342-01) </PackageDescription>
<NDC11Code>68462-0342-01</NDC11Code>
<ProductNDC>68462-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>68462-342-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-342-10) </PackageDescription>
<NDC11Code>68462-0342-10</NDC11Code>
<ProductNDC>68462-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>13668-342-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-342-05) </PackageDescription>
<NDC11Code>13668-0342-05</NDC11Code>
<ProductNDC>13668-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203370</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24208-342-05</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (24208-342-05) / 5 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>24208-0342-05</NDC11Code>
<ProductNDC>24208-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19990125</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074830</ApplicationNumber>
<LabelerName>Bauch & Lomb Incorporated</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990125</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use:Desmopressin nasal spray solution is not indicated for: 1 Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)], Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)].</IndicationAndUsage>
<Description>Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains:ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%.</Description>
</NDC>
<NDC>
<NDCCode>24338-342-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>24338-0342-05</NDC11Code>
<ProductNDC>24338-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gleostine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gleostine is an alkylating drug indicated for the treatment of patients with: : 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. (1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) .</IndicationAndUsage>
<Description>Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C9H16ClN3O2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is:. Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.</Description>
</NDC>
<NDC>
<NDCCode>31722-342-05</NDCCode>
<PackageDescription>12 BOTTLE in 1 CASE (31722-342-05) / 500 TABLET in 1 BOTTLE (31722-342-01) </PackageDescription>
<NDC11Code>31722-0342-05</NDC11Code>
<ProductNDC>31722-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091305</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen tablets are indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritits.</IndicationAndUsage>
<Description>Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid ¬soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen tablets, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>41520-342-05</NDCCode>
<PackageDescription>177 mL in 1 CAN (41520-342-05) </PackageDescription>
<NDC11Code>41520-0342-05</NDC11Code>
<ProductNDC>41520-342</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2% Oxybenzone 4%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Care One</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5; 2; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42571-342-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (42571-342-05) </PackageDescription>
<NDC11Code>42571-0342-05</NDC11Code>
<ProductNDC>42571-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213219</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules, USP for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( seeDOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride capsules, USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5 H-dibenz[b,f ]azepine monohydrochloride, and its structural formula is:. Clomipramine hydrochloride USP is a white to faintly yellow crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients:magnesium stearate and pregelatinized starch (corn). In addition, the 25 mg capsule shell contains: D&C Yellow No. 10, gelatin, iron oxide yellow and titanium dioxide. The 50 mg capsule shell contains: D&C Yellow No. 10, FD&C Blue No. 1, gelatin and titanium dioxide. The 75 mg capsule shell contains: D&C Yellow No. 10, gelatin and titanium dioxide. The black imprinting ink contains: black iron oxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>49643-342-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-342-05) </PackageDescription>
<NDC11Code>49643-0342-05</NDC11Code>
<ProductNDC>49643-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Bermuda Grass</ProprietaryName>
<NonProprietaryName>Cynodon Dactylon</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19961202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102214</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (13). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.</IndicationAndUsage>
<Description>Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense). The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration. The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response (12). Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.</Description>
</NDC>
<NDC>
<NDCCode>50419-342-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-342-05) > 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0342-05</NDC11Code>
<ProductNDC>50419-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<EndMarketingDate>20210103</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<EndMarketingDatePackage>20210103</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52536-342-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52536-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52536-0342-05</NDC11Code>
<ProductNDC>52536-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomustine</ProprietaryName>
<NonProprietaryName>Lomustine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017588</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOMUSTINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lomustine is an alkylating drug indicated for the treatment of patients with: : 1 Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. (1) , 2 Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) .</IndicationAndUsage>
<Description>Lomustine is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C9H16ClN3O2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL). The chemical structure is:. Lomustine Capsules, USP are supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.</Description>
</NDC>
<NDC>
<NDCCode>55111-342-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-342-05) </PackageDescription>
<NDC11Code>55111-0342-05</NDC11Code>
<ProductNDC>55111-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram tablets, USP contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide USP occurs as a white or almost white crystalline powder. Citalopram hydrobromide USP is soluble in methanol and sparingly soluble in water. Citalopram tablets USP, 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg of citalopram base. Citalopram tablets USP, 20 mg and 40 mg are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg of citalopram base. Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose 5 cP, hypromellose 6 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide. Iron oxides are used as coloring agents in the brown (10 mg) and pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>55150-342-05</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-05) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0342-05</NDC11Code>
<ProductNDC>55150-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212965</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride injection, USP is indicated for the following. In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1.0%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole-see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium antagonist or slow channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, clear colorless solution and is available in 5 mg/2 mL and 10 mg/4 mL single-dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil hydrochloride, USP and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of solution is between 4.0 and 6.5. Protect contents from light. Verapamil hydrochloride injection, USP vials are sterile. The structural formula of verapamil hydrochloride is given below: The chemical name of verapamil hydrochloride is Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride, USP is white or practically white, crystalline powder. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol, practically insoluble in ether. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>61919-342-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (61919-342-05) </PackageDescription>
<NDC11Code>61919-0342-05</NDC11Code>
<ProductNDC>61919-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083677</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64950-342-45</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05) </PackageDescription>
<NDC11Code>64950-0342-45</NDC11Code>
<ProductNDC>64950-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hycodan</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA005213</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>1.5; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HYCODAN is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.</IndicationAndUsage>
<Description>HYCODAN tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of HYCODAN contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. HYCODAN tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, pregelatinized starch and stearic acid. HYCODAN oral solution also contains: anhydrous citric acid, FD&C Red 40, methylparaben, natural and artificial cherry flavor, propylparaben, purified water, sorbitol solution, sodium citrate dihydrate and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>67645-342-06</NDCCode>
<PackageDescription>25 BAG in 1 CARTON (67645-342-06) / .454 kg in 1 BAG (67645-342-05) </PackageDescription>
<NDC11Code>67645-0342-06</NDC11Code>
<ProductNDC>67645-342</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>78</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68428-342-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-342-05) </PackageDescription>
<NDC11Code>68428-0342-05</NDC11Code>
<ProductNDC>68428-342</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cornus Florida</ProprietaryName>
<NonProprietaryName>Cornus Florida Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CORNUS FLORIDA BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-342-05</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68682-0342-05</NDC11Code>
<ProductNDC>68682-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074830</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use:Desmopressin nasal spray solution is not indicated for: 1 Treatment of nephrogenic diabetes insipidus,, 2 Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)],, 3 Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)],, 4 Use in patients with an impaired level of consciousness,, 5 Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths(3)].</IndicationAndUsage>
<Description>Desmopressin Nasal Spray Solution, USP is a vasopressin analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows. Molecular weight: 1183.34. Empirical formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Nasal Spray Solution, USP is an aqueous solution for intranasal use. Each mL contains:ACTIVE: Desmopressin Acetate 0.1 mg (0.01%); INACTIVES: Purified Water and Sodium Chloride. Hydrochloric Acid may be added to adjust pH (3.5 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.5%.</Description>
</NDC>
<NDC>
<NDCCode>76282-342-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (76282-342-05) </PackageDescription>
<NDC11Code>76282-0342-05</NDC11Code>
<ProductNDC>76282-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091305</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. It has the following structural formula. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>84756-342-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-342-05) </PackageDescription>
<NDC11Code>84756-0342-05</NDC11Code>
<ProductNDC>84756-342</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-wrinkle Firm Lift Night Cream</ProprietaryName>
<NonProprietaryName>Anti-wrinkle Firm Lift Night Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Guangzhou�GebianTrading�Co�Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68462-108-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-108-05) </PackageDescription>
<NDC11Code>68462-0108-05</NDC11Code>
<ProductNDC>68462-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077627</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
</NDC>
<NDC>
<NDCCode>68462-109-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-109-05) </PackageDescription>
<NDC11Code>68462-0109-05</NDC11Code>
<ProductNDC>68462-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077627</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
</NDC>
<NDC>
<NDCCode>68462-110-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05) </PackageDescription>
<NDC11Code>68462-0110-05</NDC11Code>
<ProductNDC>68462-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077627</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate Tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.</Description>
</NDC>
<NDC>
<NDCCode>68462-113-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-113-05)</PackageDescription>
<NDC11Code>68462-0113-05</NDC11Code>
<ProductNDC>68462-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077654</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68462-114-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-114-05)</PackageDescription>
<NDC11Code>68462-0114-05</NDC11Code>
<ProductNDC>68462-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077654</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68462-115-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-115-05)</PackageDescription>
<NDC11Code>68462-0115-05</NDC11Code>
<ProductNDC>68462-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077654</ApplicationNumber>
<LabelerName>Glenmark Generics Inc., USA</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68462-120-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (68462-120-05) </PackageDescription>
<NDC11Code>68462-0120-05</NDC11Code>
<ProductNDC>68462-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-121-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (68462-121-05) </PackageDescription>
<NDC11Code>68462-0121-05</NDC11Code>
<ProductNDC>68462-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216357</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>I. Stable Angina. Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension. Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Nicardipine Hydrochloride Capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine Hydrochloride Capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m‑nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure. Nicardipine Hydrochloride, USP. Molecular Formula C26H29N3O6. HCl. Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Each Nicardipine Hydrochloride Capsules, for oral administration, contains 20 mg or 30 mg nicardipine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C blue #1. The black printing ink contains black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-126-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68462-126-05) </PackageDescription>
<NDC11Code>68462-0126-05</NDC11Code>
<ProductNDC>68462-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 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 Tablets, USP is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24 g/mol. The structural formula of gabapentin, USP is. Gabapentin, USP 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 Tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, opadry white, polyethylene glycol and talc. Additionally, the coating material opadry white contains hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
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