{
"NDC": [
{
"NDCCode": "82442-344-14",
"PackageDescription": "8 CONTAINER in 1 CARTON (82442-344-14) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "82442-0344-14",
"ProductNDC": "82442-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Mint Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82442-006-14",
"PackageDescription": "473 mL in 1 BOTTLE (82442-006-14) ",
"NDC11Code": "82442-0006-14",
"ProductNDC": "82442-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Target Up And Up Spf 30 Sport Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240925",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "30; 80; 80; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240925",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "82442-873-14",
"PackageDescription": "8 CONTAINER in 1 CARTON (82442-873-14) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "82442-0873-14",
"ProductNDC": "82442-873",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Mint Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82442-344-03",
"PackageDescription": "24 LOZENGE in 1 CONTAINER (82442-344-03) ",
"NDC11Code": "82442-0344-03",
"ProductNDC": "82442-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Mint Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82442-344-09",
"PackageDescription": "27 LOZENGE in 1 CONTAINER (82442-344-09) ",
"NDC11Code": "82442-0344-09",
"ProductNDC": "82442-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Mint Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82442-344-16",
"PackageDescription": "6 CONTAINER in 1 CARTON (82442-344-16) / 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "82442-0344-16",
"ProductNDC": "82442-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Mint Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "11673-344-14",
"PackageDescription": "8 CONTAINER in 1 CARTON (11673-344-14) > 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "11673-0344-14",
"ProductNDC": "11673-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20090616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160317",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "33261-344-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (33261-344-14)",
"NDC11Code": "33261-0344-14",
"ProductNDC": "33261-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19930501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073192",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.",
"Description": "Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C29H33ClN2O2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. Each capsule, for oral administration, contains 2 mg loperamide hydrochloride. Loperamide hydrochloride capsules USP also contain the inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide."
},
{
"NDCCode": "59368-344-01",
"PackageDescription": "14 POUCH in 1 CARTON (59368-344-01) / 1 h in 1 POUCH",
"NDC11Code": "59368-0344-01",
"ProductNDC": "59368-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Transdermal System",
"NonProprietaryName": "Nicotine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20240625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074612",
"LabelerName": "Praxis, LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "14",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240625",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "66336-344-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66336-344-14)",
"NDC11Code": "66336-0344-14",
"ProductNDC": "66336-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040527",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α, α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide."
},
{
"NDCCode": "72288-344-14",
"PackageDescription": "8 CONTAINER in 1 CARTON (72288-344-14) / 27 LOZENGE in 1 CONTAINER (72288-344-09) ",
"NDC11Code": "72288-0344-14",
"ProductNDC": "72288-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077007",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210520",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82442-025-51",
"PackageDescription": "1 TUBE in 1 CARTON (82442-025-51) / 51 g in 1 TUBE",
"NDC11Code": "82442-0025-51",
"ProductNDC": "82442-025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hemorrhoid Max Strength",
"NonProprietaryName": "14.4% Glycerin, 0.25% Phenylephrine Hcl, 1% Pramoxine Hcl, 15% Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Target Corporation",
"SubstanceName": "GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM",
"StrengthNumber": "144; 2.5; 10; 150",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "82442-030-28",
"PackageDescription": "1 TUBE in 1 CARTON (82442-030-28) / 28 g in 1 TUBE",
"NDC11Code": "82442-0030-28",
"ProductNDC": "82442-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rapid Relief Hemorrhoid",
"NonProprietaryName": "14.4% Glycerin, 0.25% Phenylephrine Hcl, 5% Lidocaine, 15% Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Target Corporation",
"SubstanceName": "GLYCERIN; LIDOCAINE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "144; 50; 150; 2.5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "10702-344-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (10702-344-01) ",
"NDC11Code": "10702-0344-01",
"ProductNDC": "10702-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzhydrocodone And Acetaminophen",
"NonProprietaryName": "Benzhydrocodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190628",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA208653",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 6.12",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190628",
"SamplePackage": "N",
"IndicationAndUsage": "Benzhydrocodone and Acetaminophen tablets are indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Benzhydrocodone and Acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Benzhydrocodone and Acetaminophen tablets are an immediate-release, fixed-dose combination of an opioid agonist and acetaminophen. Benzhydrocodone and Acetaminophen tablets are white to off-white, capsule shaped tablets that contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen for oral administration. Benzhydrocodone hydrochloride is a prodrug of hydrocodone. It occurs as a fine white powder and is not affected by light. The chemical name is 6,7-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6-yl benzoate hydrochloride. The molecular formula is C 25H 26ClNO 4, which corresponds to a molecular weight of 439.93 g/mol. It has the following chemical structure:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. The molecular formula for acetaminophen is C 8H 9NO 2, which corresponds to a molecular weight of 151.16 g/mol. It has the following structural formula:. Benzhydrocodone and Acetaminophen tablets contain 4.08 mg, 6.12 mg, or 8.16 mg of Benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen and are white to off-white in color. In addition, each tablet contains the following inactive ingredients: crospovidone, microcrystalline cellulose, pregelatinized starch, Povidone K30, and stearic acid."
},
{
"NDCCode": "15370-220-28",
"PackageDescription": "2 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "15370-0220-28",
"ProductNDC": "15370-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotic (clotrimazole) Otic Solution",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20260219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217628",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1.7",
"StrengthUnit": "mg/.17mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260219",
"SamplePackage": "N",
"IndicationAndUsage": "CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use. CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes.",
"Description": "CLOTIC is a sterile preservative-free otic solution containing clotrimazole, an azole antifungal agent, at a concentration of 1% in polyethylene glycol (PEG) 400. The solution is clear colorless to slightly yellow. Each single-dose vial of CLOTIC delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole. Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula."
},
{
"NDCCode": "42571-344-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-344-01) ",
"NDC11Code": "42571-0344-01",
"ProductNDC": "42571-344",
"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": "75",
"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": "42571-344-30",
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"NDC11Code": "42571-0344-30",
"ProductNDC": "42571-344",
"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": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
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"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"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": "42571-344-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42571-344-90) ",
"NDC11Code": "42571-0344-90",
"ProductNDC": "42571-344",
"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": "75",
"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": "55111-344-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (55111-344-01) ",
"NDC11Code": "55111-0344-01",
"ProductNDC": "55111-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20241130",
"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": "55111-344-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-344-05) ",
"NDC11Code": "55111-0344-05",
"ProductNDC": "55111-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20241130",
"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": "55111-344-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55111-344-30) ",
"NDC11Code": "55111-0344-30",
"ProductNDC": "55111-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
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"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20241130",
"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": "55111-344-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55111-344-60) ",
"NDC11Code": "55111-0344-60",
"ProductNDC": "55111-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20241130",
"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": "55111-344-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-344-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-344-79) ",
"NDC11Code": "55111-0344-78",
"ProductNDC": "55111-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20041028",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077038",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041028",
"EndMarketingDatePackage": "20241130",
"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": "55150-344-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-344-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0344-01",
"ProductNDC": "55150-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213171",
"LabelerName": "Eugia US LLC",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210902",
"SamplePackage": "N",
"IndicationAndUsage": "Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).",
"Description": "Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is: The molecular formula is C72H101N17O26; the molecular weight is 1,620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake or powder containing approximately 500 mg of daptomycin for intravenous use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown."
},
{
"NDCCode": "69794-344-03",
"PackageDescription": "1 KIT in 1 CARTON (69794-344-03) * 2 mL in 1 VIAL (69794-332-01) ",
"NDC11Code": "69794-0344-03",
"ProductNDC": "69794-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genglycos",
"NonProprietaryName": "Pariglasgene Brecaparvovec-opnr",
"DosageFormName": "KIT",
"StartMarketingDate": "20260917",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125858",
"LabelerName": "Ultragenyx Pharmaceutical Inc.",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260917",
"SamplePackage": "N",
"IndicationAndUsage": "GENGLYCOS is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa). This indication is approved under accelerated approval based on reduction in daily cornstarch intake [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).",
"Description": "GENGLYCOS (pariglasgene brecaparvovec-opnr) is an adeno-associated viral vector-based gene therapy product. GENGLYCOS is a non-replicating, recombinant adeno-associated serotype 8 (AAV8) based vector containing a codon-optimized, wild-type human G6PC gene under the control of native G6PC promoter and enhancer elements. GENGLYCOS is produced in human embryonic kidney cells by recombinant DNA technology. GENGLYCOS is a sterile, clear to translucent suspension for intravenous infusion after dilution. Each vial of GENGLYCOS contains an extractable volume of 2 mL of pariglasgene brecaparvovec-opnr at a concentration of 3.0 × 1013 genome copies per mL (gc/ml) and the following excipients: magnesium chloride (0.2 mg/mL) poloxamer 188 (0.1 mg/mL), sodium chloride (11.7 mg/mL), and tris (2.4 mg/mL). The pH of GENGLYCOS is 7.5 - 8.5."
},
{
"NDCCode": "71205-344-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71205-344-30) ",
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"ProductNDC": "71205-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
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"RouteName": "ORAL",
"StartMarketingDate": "20130319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202389",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20191101",
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"IndicationAndUsage": "Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .",
"Description": "Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "71205-344-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-344-60) ",
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"ProductNDC": "71205-344",
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"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
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"IndicationAndUsage": "Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .",
"Description": "Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "71205-344-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-344-90) ",
"NDC11Code": "71205-0344-90",
"ProductNDC": "71205-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-14",
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"IndicationAndUsage": "Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .",
"Description": "Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "72426-118-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03) ",
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"ProductNDC": "72426-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexletol",
"NonProprietaryName": "Bempedoic Acid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211616",
"LabelerName": "Esperion Therapeutics, Inc.",
"SubstanceName": "BEMPEDOIC ACID",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200306",
"SamplePackage": "N",
"IndicationAndUsage": "NEXLETOL is indicated: 1 to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin)., 2 as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). .",
"Description": "NEXLETOL tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor. The chemical name for bempedoic acid is 8-hydroxy-2,2,14,14-tetramethyl-pentadecanedioic acid. The molecular formula is C19H36O5, and the molecular weight is 344.5 grams per mole. Bempedoic acid is a white to off-white crystalline powder that is highly soluble in ethanol, isopropanol and pH 8 phosphate buffer, and insoluble in water and aqueous solutions below pH 5. Structural formula. Each film-coated tablet of NEXLETOL contains 180 mg of bempedoic acid and the following inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating comprises of partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "72426-118-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-09) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexletol",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211616",
"LabelerName": "Esperion Therapeutics, Inc.",
"SubstanceName": "BEMPEDOIC ACID",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200306",
"SamplePackage": "N",
"IndicationAndUsage": "NEXLETOL is indicated: 1 To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:established cardiovascular disease (CVD), ora high risk for a CVD event but without established CVD., 2 As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).",
"Description": "NEXLETOL tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor. The chemical name for bempedoic acid is 8-hydroxy-2,2,14,14-tetramethyl-pentadecanedioic acid. The molecular formula is C19H36O5, and the molecular weight is 344.5 grams per mole. Bempedoic acid is a white to off-white crystalline powder that is highly soluble in ethanol, isopropanol and pH 8 phosphate buffer, and insoluble in water and aqueous solutions below pH 5. Structural formula. Each film-coated tablet of NEXLETOL contains 180 mg of bempedoic acid and the following inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating comprises of partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide."
}
]
}
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<ProprietaryName>Loperamide Hydrochloride</ProprietaryName>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.</IndicationAndUsage>
<Description>Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is. C29H33ClN2O2HCl M.W. 513.51. Loperamide hydrochloride is available in 2 mg capsules. Each capsule, for oral administration, contains 2 mg loperamide hydrochloride. Loperamide hydrochloride capsules USP also contain the inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59368-344-01</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (59368-344-01) / 1 h in 1 POUCH</PackageDescription>
<NDC11Code>59368-0344-01</NDC11Code>
<ProductNDC>59368-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Transdermal System</ProprietaryName>
<NonProprietaryName>Nicotine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074612</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-344-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66336-344-14)</PackageDescription>
<NDC11Code>66336-0344-14</NDC11Code>
<ProductNDC>66336-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040527</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α, α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72288-344-14</NDCCode>
<PackageDescription>8 CONTAINER in 1 CARTON (72288-344-14) / 27 LOZENGE in 1 CONTAINER (72288-344-09) </PackageDescription>
<NDC11Code>72288-0344-14</NDC11Code>
<ProductNDC>72288-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Care Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077007</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82442-025-51</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82442-025-51) / 51 g in 1 TUBE</PackageDescription>
<NDC11Code>82442-0025-51</NDC11Code>
<ProductNDC>82442-025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Hemorrhoid Max Strength</ProprietaryName>
<NonProprietaryName>14.4% Glycerin, 0.25% Phenylephrine Hcl, 1% Pramoxine Hcl, 15% Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM</SubstanceName>
<StrengthNumber>144; 2.5; 10; 150</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82442-030-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82442-030-28) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>82442-0030-28</NDC11Code>
<ProductNDC>82442-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rapid Relief Hemorrhoid</ProprietaryName>
<NonProprietaryName>14.4% Glycerin, 0.25% Phenylephrine Hcl, 5% Lidocaine, 15% Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>GLYCERIN; LIDOCAINE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>144; 50; 150; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10702-344-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (10702-344-01) </PackageDescription>
<NDC11Code>10702-0344-01</NDC11Code>
<ProductNDC>10702-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzhydrocodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Benzhydrocodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190628</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA208653</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 6.12</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzhydrocodone and Acetaminophen tablets are indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Benzhydrocodone and Acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Benzhydrocodone and Acetaminophen tablets are an immediate-release, fixed-dose combination of an opioid agonist and acetaminophen. Benzhydrocodone and Acetaminophen tablets are white to off-white, capsule shaped tablets that contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen for oral administration. Benzhydrocodone hydrochloride is a prodrug of hydrocodone. It occurs as a fine white powder and is not affected by light. The chemical name is 6,7-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6-yl benzoate hydrochloride. The molecular formula is C 25H 26ClNO 4, which corresponds to a molecular weight of 439.93 g/mol. It has the following chemical structure:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. The molecular formula for acetaminophen is C 8H 9NO 2, which corresponds to a molecular weight of 151.16 g/mol. It has the following structural formula:. Benzhydrocodone and Acetaminophen tablets contain 4.08 mg, 6.12 mg, or 8.16 mg of Benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen and are white to off-white in color. In addition, each tablet contains the following inactive ingredients: crospovidone, microcrystalline cellulose, pregelatinized starch, Povidone K30, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>15370-220-28</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>15370-0220-28</NDC11Code>
<ProductNDC>15370-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotic (clotrimazole) Otic Solution</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20260219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217628</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1.7</StrengthNumber>
<StrengthUnit>mg/.17mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use. CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes.</IndicationAndUsage>
<Description>CLOTIC is a sterile preservative-free otic solution containing clotrimazole, an azole antifungal agent, at a concentration of 1% in polyethylene glycol (PEG) 400. The solution is clear colorless to slightly yellow. Each single-dose vial of CLOTIC delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole. Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>42571-344-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42571-344-01) </PackageDescription>
<NDC11Code>42571-0344-01</NDC11Code>
<ProductNDC>42571-344</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>75</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>42571-344-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42571-344-30) </PackageDescription>
<NDC11Code>42571-0344-30</NDC11Code>
<ProductNDC>42571-344</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>75</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>42571-344-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42571-344-90) </PackageDescription>
<NDC11Code>42571-0344-90</NDC11Code>
<ProductNDC>42571-344</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>75</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>55111-344-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (55111-344-01) </PackageDescription>
<NDC11Code>55111-0344-01</NDC11Code>
<ProductNDC>55111-344</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>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</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>55111-344-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-344-05) </PackageDescription>
<NDC11Code>55111-0344-05</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041028</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</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>55111-344-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55111-344-30) </PackageDescription>
<NDC11Code>55111-0344-30</NDC11Code>
<ProductNDC>55111-344</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>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</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>55111-344-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55111-344-60) </PackageDescription>
<NDC11Code>55111-0344-60</NDC11Code>
<ProductNDC>55111-344</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>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</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>55111-344-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-344-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-344-79) </PackageDescription>
<NDC11Code>55111-0344-78</NDC11Code>
<ProductNDC>55111-344</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>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077038</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041028</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</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>55150-344-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55150-344-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0344-01</NDC11Code>
<ProductNDC>55150-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213171</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) (1.1) and,, 2 Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, (1.2), 3 Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). (1.3).</IndicationAndUsage>
<Description>Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is: The molecular formula is C72H101N17O26; the molecular weight is 1,620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake or powder containing approximately 500 mg of daptomycin for intravenous use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>69794-344-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69794-344-03) * 2 mL in 1 VIAL (69794-332-01) </PackageDescription>
<NDC11Code>69794-0344-03</NDC11Code>
<ProductNDC>69794-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Genglycos</ProprietaryName>
<NonProprietaryName>Pariglasgene Brecaparvovec-opnr</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260917</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125858</ApplicationNumber>
<LabelerName>Ultragenyx Pharmaceutical Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GENGLYCOS is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa). This indication is approved under accelerated approval based on reduction in daily cornstarch intake [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>GENGLYCOS (pariglasgene brecaparvovec-opnr) is an adeno-associated viral vector-based gene therapy product. GENGLYCOS is a non-replicating, recombinant adeno-associated serotype 8 (AAV8) based vector containing a codon-optimized, wild-type human G6PC gene under the control of native G6PC promoter and enhancer elements. GENGLYCOS is produced in human embryonic kidney cells by recombinant DNA technology. GENGLYCOS is a sterile, clear to translucent suspension for intravenous infusion after dilution. Each vial of GENGLYCOS contains an extractable volume of 2 mL of pariglasgene brecaparvovec-opnr at a concentration of 3.0 × 1013 genome copies per mL (gc/ml) and the following excipients: magnesium chloride (0.2 mg/mL) poloxamer 188 (0.1 mg/mL), sodium chloride (11.7 mg/mL), and tris (2.4 mg/mL). The pH of GENGLYCOS is 7.5 - 8.5.</Description>
</NDC>
<NDC>
<NDCCode>71205-344-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71205-344-30) </PackageDescription>
<NDC11Code>71205-0344-30</NDC11Code>
<ProductNDC>71205-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202389</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .</IndicationAndUsage>
<Description>Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>71205-344-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-344-60) </PackageDescription>
<NDC11Code>71205-0344-60</NDC11Code>
<ProductNDC>71205-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202389</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .</IndicationAndUsage>
<Description>Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.</Description>
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<NDC>
<NDCCode>71205-344-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-344-90) </PackageDescription>
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<ProprietaryName>Escitalopram</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202389</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .</IndicationAndUsage>
<Description>Escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oxalate is available as tablets. Escitalopram tablets, USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>72426-118-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03) </PackageDescription>
<NDC11Code>72426-0118-03</NDC11Code>
<ProductNDC>72426-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexletol</ProprietaryName>
<NonProprietaryName>Bempedoic Acid</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211616</ApplicationNumber>
<LabelerName>Esperion Therapeutics, Inc.</LabelerName>
<SubstanceName>BEMPEDOIC ACID</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXLETOL is indicated: 1 to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin)., 2 as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
<Description>NEXLETOL tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor. The chemical name for bempedoic acid is 8-hydroxy-2,2,14,14-tetramethyl-pentadecanedioic acid. The molecular formula is C19H36O5, and the molecular weight is 344.5 grams per mole. Bempedoic acid is a white to off-white crystalline powder that is highly soluble in ethanol, isopropanol and pH 8 phosphate buffer, and insoluble in water and aqueous solutions below pH 5. Structural formula. Each film-coated tablet of NEXLETOL contains 180 mg of bempedoic acid and the following inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating comprises of partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72426-118-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-09) </PackageDescription>
<NDC11Code>72426-0118-09</NDC11Code>
<ProductNDC>72426-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexletol</ProprietaryName>
<NonProprietaryName>Bempedoic Acid</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211616</ApplicationNumber>
<LabelerName>Esperion Therapeutics, Inc.</LabelerName>
<SubstanceName>BEMPEDOIC ACID</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXLETOL is indicated: 1 To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:established cardiovascular disease (CVD), ora high risk for a CVD event but without established CVD., 2 As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).</IndicationAndUsage>
<Description>NEXLETOL tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor. The chemical name for bempedoic acid is 8-hydroxy-2,2,14,14-tetramethyl-pentadecanedioic acid. The molecular formula is C19H36O5, and the molecular weight is 344.5 grams per mole. Bempedoic acid is a white to off-white crystalline powder that is highly soluble in ethanol, isopropanol and pH 8 phosphate buffer, and insoluble in water and aqueous solutions below pH 5. Structural formula. Each film-coated tablet of NEXLETOL contains 180 mg of bempedoic acid and the following inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating comprises of partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.</Description>
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