{
"NDC": [
{
"NDCCode": "82009-191-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-191-05) ",
"NDC11Code": "82009-0191-05",
"ProductNDC": "82009-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206465",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets is indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: .",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a off -white to light yellow coloured powder that is soluble in N,N-Dimethyl formamide, acetone and acetonitrile and insoluble in water. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, magnesium oxide, microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, triacetin, iron oxide red, iron oxide yellow (5 mg), and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "10370-191-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10370-191-05) ",
"NDC11Code": "10370-0191-05",
"ProductNDC": "10370-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150702",
"EndMarketingDate": "20190131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076467",
"LabelerName": "Par Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "27241-191-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05) ",
"NDC11Code": "27241-0191-05",
"ProductNDC": "27241-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213397",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].",
"Description": "Tolterodine tartrate extended-release capsule contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The molecular formula of tolterodine tartrate, USP is C26H37NO7,. Its structure is. Tolterodine tartrate, USP is white to off-white powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14.83 mg/mL. It is soluble in methanol, and sparingly soluble in water. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, titanium dioxide and gelatin. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, iron oxide yellow, titanium dioxide and gelatin. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, titanium dioxide, propylene glycol, and simethicone."
},
{
"NDCCode": "31722-191-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-191-05) ",
"NDC11Code": "31722-0191-05",
"ProductNDC": "31722-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207419",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2018-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170411",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of 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], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated, or are not expected to be tolerated. Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP………………………………………………….. 2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP……………………………………………………………… 325 mg. Oxycodone hydrochloride, USP …………………………………………………. 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP …………………………………………………………….. 325 mg. Oxycodone hydrochloride, USP………………………………………………….. 7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP……………………………………………………………… 325 mg. Oxycodone hydrochloride, USP…………………………………………………… 10 mg* (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………... 325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 and the 5 mg/325 mg strength contains FD&C Blue No. 1. The 7.5 mg/325 mg strength contain FD&C Yellow No. 6. The 10 mg/325 mg strength contain D&C Yellow No. 10. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "42043-191-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-191-05)",
"NDC11Code": "42043-0191-05",
"ProductNDC": "42043-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078526",
"LabelerName": "Karalex Pharma LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50742-191-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05) ",
"NDC11Code": "50742-0191-05",
"ProductNDC": "50742-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primaquine Phosphate",
"NonProprietaryName": "Primaquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206043",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "PRIMAQUINE PHOSPHATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180123",
"SamplePackage": "N",
"IndicationAndUsage": "Primaquine phosphate tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.",
"Description": "Primaquine phosphate is 8-[(4-amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. The molecular formula of primaquine phosphate is C15H21N3O·2H3PO4 and its molecular weight is 455.34. The structural formula of primaquine phosphate is. Figure 1: Primaquine phosphate structure. Each primaquine phosphate tablet, USP contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide."
},
{
"NDCCode": "53746-191-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (53746-191-05) ",
"NDC11Code": "53746-0191-05",
"ProductNDC": "53746-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium (nsaid)",
"ProprietaryNameSuffix": "Fever Reducer/ Pain Reliever",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079096",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091125",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 backache, 3 muscular aches, 4 minor pain of arthritis, 5 menstrual cramps, 6 headache, 7 toothache, 8 the common cold, 9 temporarily reduces fever."
},
{
"NDCCode": "57237-191-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (57237-191-05)",
"NDC11Code": "57237-0191-05",
"ProductNDC": "57237-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078643",
"LabelerName": "Citron Pharma LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60429-191-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (60429-191-05) ",
"NDC11Code": "60429-0191-05",
"ProductNDC": "60429-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150113",
"SamplePackage": "N"
},
{
"NDCCode": "63376-191-05",
"PackageDescription": "500 g in 1 BAG (63376-191-05)",
"NDC11Code": "63376-0191-05",
"ProductNDC": "63376-191",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Trilostane",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081205",
"EndMarketingDate": "20150512",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Suzhou Pharmaceutical Technology Co.,Ltd",
"SubstanceName": "TRILOSTANE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20150512"
},
{
"NDCCode": "63646-191-05",
"PackageDescription": "6 TRAY in 1 CARTON (63646-191-05) > 1 KIT in 1 TRAY (63646-191-06) * 500 mg in 1 SYRINGE (63646-193-08) * 450 mg in 1 SYRINGE (63646-192-07)",
"NDC11Code": "63646-0191-05",
"ProductNDC": "63646-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atridox",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "19980903",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050751",
"LabelerName": "TOLMAR Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "64220-191-05",
"PackageDescription": "10 kg in 1 DRUM (64220-191-05) ",
"NDC11Code": "64220-0191-05",
"ProductNDC": "64220-191",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231024",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "MIRABEGRON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-10-25",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "24-OCT-23"
},
{
"NDCCode": "65841-191-05",
"PackageDescription": "1 POUCH in 1 DRUM (65841-191-05) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 25 kg in 1 BAG",
"NDC11Code": "65841-0191-05",
"ProductNDC": "65841-191",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-18",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JAN-25"
},
{
"NDCCode": "65862-191-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05) ",
"NDC11Code": "65862-0191-05",
"ProductNDC": "65862-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078643",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080926",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "66096-191-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-191-05) ",
"NDC11Code": "66096-0191-05",
"ProductNDC": "66096-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Cholesterol Aid",
"NonProprietaryName": "Cholesterinum, Fel Tauri, Guatteria Guameri.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CHOLESTEROL; BOS TAURUS BILE; MALMEA DEPRESSA BARK",
"StrengthNumber": "13; 3; 5",
"StrengthUnit": "[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves ailments related with slow hepatic metabolism resulting in elevated cholesterol levels.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "67777-191-05",
"PackageDescription": "144 TUBE in 1 CASE (67777-191-05) / 42.5 g in 1 TUBE (67777-191-04) ",
"NDC11Code": "67777-0191-05",
"ProductNDC": "67777-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bubble Fresh Toothpaste, With Fluoride",
"NonProprietaryName": "Bubble Fresh Toothpaste, With Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "220",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "68382-191-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-191-05) ",
"NDC11Code": "68382-0191-05",
"ProductNDC": "68382-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091390",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)., 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its molecular formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil, USP is a white to almost white powder with a molecular weight of 610.67. It is practically insoluble in water, soluble in methylene chloride and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Each candesartan cilexetil tablet, USP intended for oral administration contains 4 mg or 8 mg or 16 mg or 32 mg candesartan cilexetil. In addition each tablet contains the following inactive ingredients: carboxymethyl cellulose calcium, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and polyethylene glycol. Additionally each 4 mg and 8 mg tablet contains ferric oxide red."
},
{
"NDCCode": "68428-191-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-191-05) ",
"NDC11Code": "68428-0191-05",
"ProductNDC": "68428-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Althaea Officinalis",
"NonProprietaryName": "Althaea Officinalis Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ALTHAEA OFFICINALIS ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090914",
"SamplePackage": "N"
},
{
"NDCCode": "72578-191-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-191-05) ",
"NDC11Code": "72578-0191-05",
"ProductNDC": "72578-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217445",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone extended-release tablets is an atypical antipsychotic agent indicated for. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).",
"Description": "Paliperidone extended-release tablets contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N hydrochloride and methylene chloride; practically insoluble in water, 0.1N sodium hydroxide and hexane; and slightly soluble in N,N-dimethylformamide, tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off white), 6 mg (beige) and 9 mg (pink) strengths. Paliperidone extended-release tablets utilizes OROS® osmotic drug-release technology. Paliperidone extended-release tablets contain the following inactive ingredients: butylated hydroxy toluene, cellulose acetate, ferric oxide red, hydroxy ethyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, sodium stearyl fumarate and titanium dioxide. Additionally, each 1.5 mg and 6 mg tablet contains iron oxide yellow, and 3 mg tablet contains talc. The tablet is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, propylene glycol and shellac. Delivery System Components and Performance. Paliperidone Extended-Release Tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is two precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components."
},
{
"NDCCode": "82009-008-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (82009-008-05) ",
"NDC11Code": "82009-0008-05",
"ProductNDC": "82009-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "Quallent",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211203",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: : 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. , 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. , 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets for oral use contains 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide."
},
{
"NDCCode": "82009-016-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05) ",
"NDC11Code": "82009-0016-05",
"ProductNDC": "82009-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200895",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220526",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β (2 S*,4 S*),-8a]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "82009-021-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) ",
"NDC11Code": "82009-0021-05",
"ProductNDC": "82009-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221115",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076273",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221115",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"Description": "Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. Each tablet contains 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol and microcrystalline cellulose as inactive ingredients. The film coating contains hypromellose 2910-5cP, polyethylene glycol 400 and titanium dioxide."
},
{
"NDCCode": "82009-023-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05) ",
"NDC11Code": "82009-0023-05",
"ProductNDC": "82009-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078490",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells contains: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "82009-024-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (82009-024-05) ",
"NDC11Code": "82009-0024-05",
"ProductNDC": "82009-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204331",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220820",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .",
"Description": "Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate."
},
{
"NDCCode": "82009-029-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05) ",
"NDC11Code": "82009-0029-05",
"ProductNDC": "82009-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Quallent Pharmaceuticals Health, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221215",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "82009-039-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05) ",
"NDC11Code": "82009-0039-05",
"ProductNDC": "82009-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203083",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221014",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1) Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) Maintenance of healed duodenal ulcers in adults. ( 1.3) Treatment of active benign gastric ulcer in adults. ( 1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) Maintenance of healing of EE in adults. ( 1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.36. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole delayed-release capsules, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "82009-045-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05) ",
"NDC11Code": "82009-0045-05",
"ProductNDC": "82009-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040657",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).",
"Description": "Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide."
},
{
"NDCCode": "82009-049-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05) ",
"NDC11Code": "82009-0049-05",
"ProductNDC": "82009-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "82009-050-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (82009-050-05) ",
"NDC11Code": "82009-0050-05",
"ProductNDC": "82009-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230928",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "82009-051-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-051-05) ",
"NDC11Code": "82009-0051-05",
"ProductNDC": "82009-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090693",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230707",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>82009-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-191-05) </PackageDescription>
<NDC11Code>82009-0191-05</NDC11Code>
<ProductNDC>82009-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206465</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets is indicated: : 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: .</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a off -white to light yellow coloured powder that is soluble in N,N-Dimethyl formamide, acetone and acetonitrile and insoluble in water. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, magnesium oxide, microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, triacetin, iron oxide red, iron oxide yellow (5 mg), and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>10370-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10370-191-05) </PackageDescription>
<NDC11Code>10370-0191-05</NDC11Code>
<ProductNDC>10370-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<EndMarketingDate>20190131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076467</ApplicationNumber>
<LabelerName>Par Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>27241-191-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05) </PackageDescription>
<NDC11Code>27241-0191-05</NDC11Code>
<ProductNDC>27241-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213397</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>Tolterodine tartrate extended-release capsule contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The molecular formula of tolterodine tartrate, USP is C26H37NO7,. Its structure is. Tolterodine tartrate, USP is white to off-white powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 14.83 mg/mL. It is soluble in methanol, and sparingly soluble in water. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, titanium dioxide and gelatin. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, USP. Inactive ingredients are microcrystalline cellulose, hypromellose, ethyl cellulose, medium chain triglycerides and oleic acids. The capsule shell contains FD&C Blue 2, iron oxide yellow, titanium dioxide and gelatin. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac, titanium dioxide, propylene glycol, and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>31722-191-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-191-05) </PackageDescription>
<NDC11Code>31722-0191-05</NDC11Code>
<ProductNDC>31722-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207419</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets is indicated for the management of 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], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated, or are not expected to be tolerated. Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP………………………………………………….. 2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP……………………………………………………………… 325 mg. Oxycodone hydrochloride, USP …………………………………………………. 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP …………………………………………………………….. 325 mg. Oxycodone hydrochloride, USP………………………………………………….. 7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP……………………………………………………………… 325 mg. Oxycodone hydrochloride, USP…………………………………………………… 10 mg* (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………... 325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 and the 5 mg/325 mg strength contains FD&C Blue No. 1. The 7.5 mg/325 mg strength contain FD&C Yellow No. 6. The 10 mg/325 mg strength contain D&C Yellow No. 10. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>42043-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-191-05)</PackageDescription>
<NDC11Code>42043-0191-05</NDC11Code>
<ProductNDC>42043-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078526</ApplicationNumber>
<LabelerName>Karalex Pharma LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50742-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05) </PackageDescription>
<NDC11Code>50742-0191-05</NDC11Code>
<ProductNDC>50742-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primaquine Phosphate</ProprietaryName>
<NonProprietaryName>Primaquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206043</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PRIMAQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primaquine phosphate tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.</IndicationAndUsage>
<Description>Primaquine phosphate is 8-[(4-amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. The molecular formula of primaquine phosphate is C15H21N3O·2H3PO4 and its molecular weight is 455.34. The structural formula of primaquine phosphate is. Figure 1: Primaquine phosphate structure. Each primaquine phosphate tablet, USP contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53746-191-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (53746-191-05) </PackageDescription>
<NDC11Code>53746-0191-05</NDC11Code>
<ProductNDC>53746-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium (nsaid)</ProprietaryName>
<ProprietaryNameSuffix>Fever Reducer/ Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079096</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 backache, 3 muscular aches, 4 minor pain of arthritis, 5 menstrual cramps, 6 headache, 7 toothache, 8 the common cold, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57237-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (57237-191-05)</PackageDescription>
<NDC11Code>57237-0191-05</NDC11Code>
<ProductNDC>57237-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078643</ApplicationNumber>
<LabelerName>Citron Pharma LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60429-191-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (60429-191-05) </PackageDescription>
<NDC11Code>60429-0191-05</NDC11Code>
<ProductNDC>60429-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63376-191-05</NDCCode>
<PackageDescription>500 g in 1 BAG (63376-191-05)</PackageDescription>
<NDC11Code>63376-0191-05</NDC11Code>
<ProductNDC>63376-191</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Trilostane</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081205</StartMarketingDate>
<EndMarketingDate>20150512</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Suzhou Pharmaceutical Technology Co.,Ltd</LabelerName>
<SubstanceName>TRILOSTANE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20150512</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63646-191-05</NDCCode>
<PackageDescription>6 TRAY in 1 CARTON (63646-191-05) > 1 KIT in 1 TRAY (63646-191-06) * 500 mg in 1 SYRINGE (63646-193-08) * 450 mg in 1 SYRINGE (63646-192-07)</PackageDescription>
<NDC11Code>63646-0191-05</NDC11Code>
<ProductNDC>63646-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atridox</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980903</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050751</ApplicationNumber>
<LabelerName>TOLMAR Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64220-191-05</NDCCode>
<PackageDescription>10 kg in 1 DRUM (64220-191-05) </PackageDescription>
<NDC11Code>64220-0191-05</NDC11Code>
<ProductNDC>64220-191</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231024</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>MIRABEGRON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-25</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-OCT-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65841-191-05</NDCCode>
<PackageDescription>1 POUCH in 1 DRUM (65841-191-05) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 25 kg in 1 BAG</PackageDescription>
<NDC11Code>65841-0191-05</NDC11Code>
<ProductNDC>65841-191</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-18</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05) </PackageDescription>
<NDC11Code>65862-0191-05</NDC11Code>
<ProductNDC>65862-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078643</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pKa of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>66096-191-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-191-05) </PackageDescription>
<NDC11Code>66096-0191-05</NDC11Code>
<ProductNDC>66096-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Cholesterol Aid</ProprietaryName>
<NonProprietaryName>Cholesterinum, Fel Tauri, Guatteria Guameri.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CHOLESTEROL; BOS TAURUS BILE; MALMEA DEPRESSA BARK</SubstanceName>
<StrengthNumber>13; 3; 5</StrengthNumber>
<StrengthUnit>[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves ailments related with slow hepatic metabolism resulting in elevated cholesterol levels.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67777-191-05</NDCCode>
<PackageDescription>144 TUBE in 1 CASE (67777-191-05) / 42.5 g in 1 TUBE (67777-191-04) </PackageDescription>
<NDC11Code>67777-0191-05</NDC11Code>
<ProductNDC>67777-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bubble Fresh Toothpaste, With Fluoride</ProprietaryName>
<NonProprietaryName>Bubble Fresh Toothpaste, With Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68382-191-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-191-05) </PackageDescription>
<NDC11Code>68382-0191-05</NDC11Code>
<ProductNDC>68382-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091390</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)., 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its molecular formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil, USP is a white to almost white powder with a molecular weight of 610.67. It is practically insoluble in water, soluble in methylene chloride and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Each candesartan cilexetil tablet, USP intended for oral administration contains 4 mg or 8 mg or 16 mg or 32 mg candesartan cilexetil. In addition each tablet contains the following inactive ingredients: carboxymethyl cellulose calcium, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and polyethylene glycol. Additionally each 4 mg and 8 mg tablet contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>68428-191-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-191-05) </PackageDescription>
<NDC11Code>68428-0191-05</NDC11Code>
<ProductNDC>68428-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Althaea Officinalis</ProprietaryName>
<NonProprietaryName>Althaea Officinalis Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090914</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ALTHAEA OFFICINALIS ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72578-191-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-191-05) </PackageDescription>
<NDC11Code>72578-0191-05</NDC11Code>
<ProductNDC>72578-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217445</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone extended-release tablets is an atypical antipsychotic agent indicated for. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.48. The structural formula is. Paliperidone, USP is sparingly soluble in 0.1N hydrochloride and methylene chloride; practically insoluble in water, 0.1N sodium hydroxide and hexane; and slightly soluble in N,N-dimethylformamide, tetrahydrofuran. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off white), 6 mg (beige) and 9 mg (pink) strengths. Paliperidone extended-release tablets utilizes OROS® osmotic drug-release technology. Paliperidone extended-release tablets contain the following inactive ingredients: butylated hydroxy toluene, cellulose acetate, ferric oxide red, hydroxy ethyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, povidone, sodium chloride, sodium stearyl fumarate and titanium dioxide. Additionally, each 1.5 mg and 6 mg tablet contains iron oxide yellow, and 3 mg tablet contains talc. The tablet is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, propylene glycol and shellac. Delivery System Components and Performance. Paliperidone Extended-Release Tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a round-shaped tablet in appearance, consists of an osmotically active bilayer core surrounded by a subcoat and semipermeable membrane. The bilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is two precision laser-drilled orifice on the drug-layer side of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifice. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.</Description>
</NDC>
<NDC>
<NDCCode>82009-008-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82009-008-05) </PackageDescription>
<NDC11Code>82009-0008-05</NDC11Code>
<ProductNDC>82009-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>Quallent</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: : 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. , 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. , 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets for oral use contains 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-016-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05) </PackageDescription>
<NDC11Code>82009-0016-05</NDC11Code>
<ProductNDC>82009-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200895</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β (2 S*,4 S*),-8a]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin USP is a white to off-white crystalline powder that is practically insoluble in water, freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol and very slightly soluble in hexane. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Additionally the 10 mg, 20 mg, 40 mg and 80 mg strengths contain: iron oxide red. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>82009-021-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) </PackageDescription>
<NDC11Code>82009-0021-05</NDC11Code>
<ProductNDC>82009-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076273</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as white, film coated, round, biconvex tablets debossed with “R” on one side and “196” on other side. Each tablet contains 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol and microcrystalline cellulose as inactive ingredients. The film coating contains hypromellose 2910-5cP, polyethylene glycol 400 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-023-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05) </PackageDescription>
<NDC11Code>82009-0023-05</NDC11Code>
<ProductNDC>82009-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078490</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells contains: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>82009-024-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82009-024-05) </PackageDescription>
<NDC11Code>82009-0024-05</NDC11Code>
<ProductNDC>82009-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204331</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
<Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>82009-029-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05) </PackageDescription>
<NDC11Code>82009-0029-05</NDC11Code>
<ProductNDC>82009-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-039-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05) </PackageDescription>
<NDC11Code>82009-0039-05</NDC11Code>
<ProductNDC>82009-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203083</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1) Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) Maintenance of healed duodenal ulcers in adults. ( 1.3) Treatment of active benign gastric ulcer in adults. ( 1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) Maintenance of healing of EE in adults. ( 1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.36. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole delayed-release capsules, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-045-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-045-05) </PackageDescription>
<NDC11Code>82009-0045-05</NDC11Code>
<ProductNDC>82009-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040657</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1), 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1), 3 Treatment of rheumatoid arthritis in adults. (1.2), 4 Treatment of systemic lupus erythematosus in adults. (1.3), 5 Treatment of chronic discoid lupus erythematosus in adults. (1.4).</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate tablet, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>82009-049-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05) </PackageDescription>
<NDC11Code>82009-0049-05</NDC11Code>
<ProductNDC>82009-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82009-050-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (82009-050-05) </PackageDescription>
<NDC11Code>82009-0050-05</NDC11Code>
<ProductNDC>82009-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>82009-051-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-051-05) </PackageDescription>
<NDC11Code>82009-0051-05</NDC11Code>
<ProductNDC>82009-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090693</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1 propanone hydrochloride. The molecular weight is 276.21. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablet USP (XL) is supplied for oral administration as 150 mg and 300 mg, off-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, glyceryl behenate, hydrophobic colloidal silica, hydroxypropyl cellulose, iron oxide black, L-cysteine hydrochloride monohydrate, methacrylic acid copolymer dispersion, polyvinyl alcohol, povidone, propylene glycol, shellac and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The Drug Product Meets USP Dissolution Test 20.</Description>
</NDC>
</NDCList>