{
"NDC": [
{
"NDCCode": "16571-759-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-759-50) ",
"NDC11Code": "16571-0759-50",
"ProductNDC": "16571-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205544",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201216",
"SamplePackage": "N",
"IndicationAndUsage": "Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.",
"Description": "Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow."
},
{
"NDCCode": "16571-759-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-759-01) ",
"NDC11Code": "16571-0759-01",
"ProductNDC": "16571-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205544",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201216",
"SamplePackage": "N",
"IndicationAndUsage": "Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.",
"Description": "Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow."
},
{
"NDCCode": "16571-759-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-759-09) ",
"NDC11Code": "16571-0759-09",
"ProductNDC": "16571-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205544",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201216",
"SamplePackage": "N",
"IndicationAndUsage": "Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.",
"Description": "Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow."
},
{
"NDCCode": "13537-759-01",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (13537-759-01)",
"NDC11Code": "13537-0759-01",
"ProductNDC": "13537-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Momentos Libertad Antiperspirant Roll-on Deodorant",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160819",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".136",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces underarm perspiration ."
},
{
"NDCCode": "37205-759-71",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (37205-759-71) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "37205-0759-71",
"ProductNDC": "37205-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Pain Reliever Pm",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "CARDINAL HEALTH",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19940515",
"SamplePackage": "N"
},
{
"NDCCode": "42291-759-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (42291-759-50) ",
"NDC11Code": "42291-0759-50",
"ProductNDC": "42291-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "AvKARE",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150805",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia:For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "49527-759-01",
"PackageDescription": "1 JAR in 1 CARTON (49527-759-01) > 50 mL in 1 JAR (49527-759-02)",
"NDC11Code": "49527-0759-01",
"ProductNDC": "49527-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Even Better Skin Tone Correcting Mosturizer",
"ProprietaryNameSuffix": "Spf 20",
"NonProprietaryName": "Octisalate, Avobenzone, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CLINIQUE LABORATORIES, INC.",
"SubstanceName": "OCTISALATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "5; 3; 2.7",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50268-759-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-759-15) / 1 TABLET in 1 BLISTER PACK (50268-759-11) ",
"NDC11Code": "50268-0759-15",
"ProductNDC": "50268-759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "AvPAK",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170824",
"SamplePackage": "N"
},
{
"NDCCode": "69039-759-02",
"PackageDescription": "1 TUBE in 1 CARTON (69039-759-02) / 50 mL in 1 TUBE (69039-759-01) ",
"NDC11Code": "69039-0759-02",
"ProductNDC": "69039-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Bum 30 Mineral Sunscreen Face 1.7 Oz",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sun Bum, LLC",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "24; 53",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "69842-759-11",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (69842-759-11) * 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "69842-0759-11",
"ProductNDC": "69842-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "KIT",
"StartMarketingDate": "20200128",
"EndMarketingDate": "20230611",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "CVS PHARMACY",
"Status": "Deprecated",
"LastUpdate": "2023-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200128",
"EndMarketingDatePackage": "20230611",
"SamplePackage": "N"
},
{
"NDCCode": "71919-772-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) ",
"NDC11Code": "71919-0772-18",
"ProductNDC": "71919-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c And 200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts."
},
{
"NDCCode": "71919-822-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) ",
"NDC11Code": "71919-0822-18",
"ProductNDC": "71919-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "84515-759-01",
"PackageDescription": "50 mL in 1 BOX (84515-759-01) ",
"NDC11Code": "84515-0759-01",
"ProductNDC": "84515-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Certified Organic Castor Oil",
"NonProprietaryName": "Certified Organic Castor Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241024",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL; PALMITOYL TRIPEPTIDE-1",
"StrengthNumber": "5; 5",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241024",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84682-759-01",
"PackageDescription": "50 g in 1 BOX (84682-759-01) ",
"NDC11Code": "84682-0759-01",
"ProductNDC": "84682-759",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rice Ceramide",
"NonProprietaryName": "Rice Ceramide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241025",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241025",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "16571-101-50",
"PackageDescription": "48 BOTTLE in 1 CASE (16571-101-50) > 5 mL in 1 BOTTLE",
"NDC11Code": "16571-0101-50",
"ProductNDC": "16571-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20080620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078553",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20080620",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.",
"Description": "Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cll2NO2Na. The structural formula of diclofenac sodium is. Diclofenac sodium ophthalmic solution is available as a sterile solution which contains diclofenac sodium 0.1% (1mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water for injection. Diclofenac sodium is a faintly yellow-white to light beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil."
},
{
"NDCCode": "16571-112-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-112-50) ",
"NDC11Code": "16571-0112-50",
"ProductNDC": "16571-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210959",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230529",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the. Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1):Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.",
"Description": "Hydroxychloroquine 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 USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: lactose monohydrate, magnesium stearate, maize starch and povidone. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-113-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50) ",
"NDC11Code": "16571-0113-50",
"ProductNDC": "16571-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217652",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3."
},
{
"NDCCode": "16571-114-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-114-50) ",
"NDC11Code": "16571-0114-50",
"ProductNDC": "16571-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217652",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3."
},
{
"NDCCode": "16571-115-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-115-50) ",
"NDC11Code": "16571-0115-50",
"ProductNDC": "16571-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217652",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3."
},
{
"NDCCode": "16571-116-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-116-50) ",
"NDC11Code": "16571-0116-50",
"ProductNDC": "16571-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230719",
"EndMarketingDate": "20260208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217995",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230719",
"EndMarketingDatePackage": "20260208",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-117-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-117-50) ",
"NDC11Code": "16571-0117-50",
"ProductNDC": "16571-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217995",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230719",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "16571-120-50",
"PackageDescription": "48 BOTTLE in 1 CASE (16571-120-50) > 5 mL in 1 BOTTLE",
"NDC11Code": "16571-0120-50",
"ProductNDC": "16571-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20080320",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers: Pseudomonas aeruginosaSerratia marcescens *Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group) *. Conjunctivitis: Haemophilus influenzaeStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin ophthalmic solution contains: Active: Ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
},
{
"NDCCode": "16571-126-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-126-50) ",
"NDC11Code": "16571-0126-50",
"ProductNDC": "16571-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204721",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose]."
},
{
"NDCCode": "16571-127-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50) ",
"NDC11Code": "16571-0127-50",
"ProductNDC": "16571-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204721",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose]."
},
{
"NDCCode": "16571-130-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (16571-130-50) > 5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "16571-0130-50",
"ProductNDC": "16571-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100104",
"EndMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078559",
"LabelerName": "Pack Pharmaceuticals, LLC",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-07-03"
},
{
"NDCCode": "16571-135-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (16571-135-50) > 5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "16571-0135-50",
"ProductNDC": "16571-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077568",
"LabelerName": "Pack Pharmaceuticals, LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:.",
"Description": "Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm."
},
{
"NDCCode": "16571-136-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-136-50) ",
"NDC11Code": "16571-0136-50",
"ProductNDC": "16571-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-137-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-137-50) ",
"NDC11Code": "16571-0137-50",
"ProductNDC": "16571-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-138-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-138-50) ",
"NDC11Code": "16571-0138-50",
"ProductNDC": "16571-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "16571-139-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (16571-139-50) ",
"NDC11Code": "16571-0139-50",
"ProductNDC": "16571-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>16571-759-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-759-50) </PackageDescription>
<NDC11Code>16571-0759-50</NDC11Code>
<ProductNDC>16571-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205544</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>16571-759-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16571-759-01) </PackageDescription>
<NDC11Code>16571-0759-01</NDC11Code>
<ProductNDC>16571-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205544</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>16571-759-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-759-09) </PackageDescription>
<NDC11Code>16571-0759-09</NDC11Code>
<ProductNDC>16571-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205544</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Nateglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Nateglinide Tablets, (-)-N- [(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, are structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Nateglinide Tablets, USP biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration. Inactive Ingredients:colloidal silicon dioxide, corn starch, hypromellose, mannitol, polyethylene glycol, povidone, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide. In addition, the 60 mg contains iron oxide red and the 120 mg contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>13537-759-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (13537-759-01)</PackageDescription>
<NDC11Code>13537-0759-01</NDC11Code>
<ProductNDC>13537-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Momentos Libertad Antiperspirant Roll-on Deodorant</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160819</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.136</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces underarm perspiration .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37205-759-71</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (37205-759-71) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37205-0759-71</NDC11Code>
<ProductNDC>37205-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Pain Reliever Pm</ProprietaryName>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>CARDINAL HEALTH</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-759-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42291-759-50) </PackageDescription>
<NDC11Code>42291-0759-50</NDC11Code>
<ProductNDC>42291-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia:For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.jiroveci pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>49527-759-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (49527-759-01) > 50 mL in 1 JAR (49527-759-02)</PackageDescription>
<NDC11Code>49527-0759-01</NDC11Code>
<ProductNDC>49527-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Even Better Skin Tone Correcting Mosturizer</ProprietaryName>
<ProprietaryNameSuffix>Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate, Avobenzone, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CLINIQUE LABORATORIES, INC.</LabelerName>
<SubstanceName>OCTISALATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>5; 3; 2.7</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50268-759-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-759-15) / 1 TABLET in 1 BLISTER PACK (50268-759-11) </PackageDescription>
<NDC11Code>50268-0759-15</NDC11Code>
<ProductNDC>50268-759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69039-759-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69039-759-02) / 50 mL in 1 TUBE (69039-759-01) </PackageDescription>
<NDC11Code>69039-0759-02</NDC11Code>
<ProductNDC>69039-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Bum 30 Mineral Sunscreen Face 1.7 Oz</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Sun Bum, LLC</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>24; 53</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-759-11</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (69842-759-11) * 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69842-0759-11</NDC11Code>
<ProductNDC>69842-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200128</StartMarketingDate>
<EndMarketingDate>20230611</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200128</StartMarketingDatePackage>
<EndMarketingDatePackage>20230611</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-772-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) </PackageDescription>
<NDC11Code>71919-0772-18</NDC11Code>
<ProductNDC>71919-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>30c And 200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-822-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) </PackageDescription>
<NDC11Code>71919-0822-18</NDC11Code>
<ProductNDC>71919-822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240229</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84515-759-01</NDCCode>
<PackageDescription>50 mL in 1 BOX (84515-759-01) </PackageDescription>
<NDC11Code>84515-0759-01</NDC11Code>
<ProductNDC>84515-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Certified Organic Castor Oil</ProprietaryName>
<NonProprietaryName>Certified Organic Castor Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241024</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL; PALMITOYL TRIPEPTIDE-1</SubstanceName>
<StrengthNumber>5; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241024</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84682-759-01</NDCCode>
<PackageDescription>50 g in 1 BOX (84682-759-01) </PackageDescription>
<NDC11Code>84682-0759-01</NDC11Code>
<ProductNDC>84682-759</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rice Ceramide</ProprietaryName>
<NonProprietaryName>Rice Ceramide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241025</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241025</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-101-50</NDCCode>
<PackageDescription>48 BOTTLE in 1 CASE (16571-101-50) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16571-0101-50</NDC11Code>
<ProductNDC>16571-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20080620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078553</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.</IndicationAndUsage>
<Description>Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cll2NO2Na. The structural formula of diclofenac sodium is. Diclofenac sodium ophthalmic solution is available as a sterile solution which contains diclofenac sodium 0.1% (1mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water for injection. Diclofenac sodium is a faintly yellow-white to light beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil.</Description>
</NDC>
<NDC>
<NDCCode>16571-112-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-112-50) </PackageDescription>
<NDC11Code>16571-0112-50</NDC11Code>
<ProductNDC>16571-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210959</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</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>2024-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the. Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1):Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
<Description>Hydroxychloroquine 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 USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: lactose monohydrate, magnesium stearate, maize starch and povidone. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-113-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50) </PackageDescription>
<NDC11Code>16571-0113-50</NDC11Code>
<ProductNDC>16571-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217652</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3.</Description>
</NDC>
<NDC>
<NDCCode>16571-114-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-114-50) </PackageDescription>
<NDC11Code>16571-0114-50</NDC11Code>
<ProductNDC>16571-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217652</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3.</Description>
</NDC>
<NDC>
<NDCCode>16571-115-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-115-50) </PackageDescription>
<NDC11Code>16571-0115-50</NDC11Code>
<ProductNDC>16571-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217652</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27ClN2O2 . 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water. Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3.</Description>
</NDC>
<NDC>
<NDCCode>16571-116-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-116-50) </PackageDescription>
<NDC11Code>16571-0116-50</NDC11Code>
<ProductNDC>16571-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<EndMarketingDate>20260208</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217995</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<EndMarketingDatePackage>20260208</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-117-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-117-50) </PackageDescription>
<NDC11Code>16571-0117-50</NDC11Code>
<ProductNDC>16571-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217995</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate. The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-120-50</NDCCode>
<PackageDescription>48 BOTTLE in 1 CASE (16571-120-50) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16571-0120-50</NDC11Code>
<ProductNDC>16571-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077689</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers: Pseudomonas aeruginosaSerratia marcescens *Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group) *. Conjunctivitis: Haemophilus influenzaeStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin ophthalmic solution contains: Active: Ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>16571-126-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-126-50) </PackageDescription>
<NDC11Code>16571-0126-50</NDC11Code>
<ProductNDC>16571-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204721</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose].</Description>
</NDC>
<NDC>
<NDCCode>16571-127-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50) </PackageDescription>
<NDC11Code>16571-0127-50</NDC11Code>
<ProductNDC>16571-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204721</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, 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>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7 , and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white 03A18585 [hypromellose, purified stearic acid, titanium dioxide, microcrystalline cellulose].</Description>
</NDC>
<NDC>
<NDCCode>16571-130-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (16571-130-50) > 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>16571-0130-50</NDC11Code>
<ProductNDC>16571-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100104</StartMarketingDate>
<EndMarketingDate>20150630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078559</ApplicationNumber>
<LabelerName>Pack Pharmaceuticals, LLC</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>16571-135-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (16571-135-50) > 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>16571-0135-50</NDC11Code>
<ProductNDC>16571-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20100915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077568</ApplicationNumber>
<LabelerName>Pack Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:.</IndicationAndUsage>
<Description>Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.</Description>
</NDC>
<NDC>
<NDCCode>16571-136-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-136-50) </PackageDescription>
<NDC11Code>16571-0136-50</NDC11Code>
<ProductNDC>16571-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-137-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-137-50) </PackageDescription>
<NDC11Code>16571-0137-50</NDC11Code>
<ProductNDC>16571-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-138-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-138-50) </PackageDescription>
<NDC11Code>16571-0138-50</NDC11Code>
<ProductNDC>16571-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</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>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>16571-139-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16571-139-50) </PackageDescription>
<NDC11Code>16571-0139-50</NDC11Code>
<ProductNDC>16571-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</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>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. â—‹ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. â—‹ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. â—‹ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. â—‹ Adults with primary hyperlipidemia. â—‹ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. â—‹ Primary dysbetalipoproteinemia. â—‹ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin Calcium Tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
</NDCList>