{
"NDC": [
{
"NDCCode": "17312-035-16",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (17312-035-16) > 8 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "17312-0035-16",
"ProductNDC": "17312-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smokers Nicotine Relief",
"NonProprietaryName": "Aspidosperma Quebracho Blanco, Avena Sativa, Epinephrine, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Valerian, Wood Creosote",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20150322",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; EPINEPHRINE; AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN",
"StrengthNumber": "6; 18; 18; 18; 9; 12; 18; 18; 18",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: cravings withdrawal irritability nicotine cleansing cough/lung support after diagnosis by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "17312-036-16",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (17312-036-16) > 8 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "17312-0036-16",
"ProductNDC": "17312-036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smokers Appetite Relief",
"NonProprietaryName": "Avena Sativa, Berberis Vulgaris, Capsicum, Fucus Vesiculosus, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Wood Creosote",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20150323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAPSICUM; MILK THISTLE; FUCUS VESICULOSUS; ST. JOHN'S WORT; WOOD CREOSOTE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "9; 12; 6; 6; 6; 6; 18; 12; 18",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "16729-035-16",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16) ",
"NDC11Code": "16729-0035-16",
"ProductNDC": "16729-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090568",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110321",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .",
"Description": "Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "43419-035-16",
"PackageDescription": "1 JAR in 1 CARTON (43419-035-16) > 11 g in 1 JAR",
"NDC11Code": "43419-0035-16",
"ProductNDC": "43419-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulwhasoo Evenfair Compact No.24",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140205",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Amorepacific Corporation",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".22; 2.2",
"StrengthUnit": "g/11g; g/11g",
"Status": "Deprecated",
"LastUpdate": "2019-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181105",
"SamplePackage": "N"
},
{
"NDCCode": "49035-035-16",
"PackageDescription": "473 mL in 1 BOTTLE (49035-035-16) ",
"NDC11Code": "49035-0035-16",
"ProductNDC": "49035-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Oil",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "OIL",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20270828",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141031",
"EndMarketingDatePackage": "20270828",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 6 to 8 hours."
},
{
"NDCCode": "63776-035-16",
"PackageDescription": "100 mL in 1 BOTTLE (63776-035-16) ",
"NDC11Code": "63776-0035-16",
"ProductNDC": "63776-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthros",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN",
"StrengthNumber": "30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "68382-035-16",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-16) ",
"NDC11Code": "68382-0035-16",
"ProductNDC": "68382-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110601",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7."
},
{
"NDCCode": "69804-035-16",
"PackageDescription": "113400 mg in 1 BOTTLE, DISPENSING (69804-035-16)",
"NDC11Code": "69804-0035-16",
"ProductNDC": "69804-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Naturally Hl Itch Relief",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170203",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ridge properties",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "73069-035-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-16",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "81033-035-16",
"PackageDescription": "10 CUP, UNIT-DOSE in 1 CARTON (81033-035-16) / 8 mL in 1 CUP, UNIT-DOSE (81033-035-08) ",
"NDC11Code": "81033-0035-16",
"ProductNDC": "81033-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217795",
"LabelerName": "Kesin Pharma",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate oral solution is indicated for: Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2). Preventive treatment of migraine in patients 12 years of age and older ( 1.3).",
"Description": "Topiramate oral solution is available as a 25 mg/mL solution for oral administration. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate is a white to off white powder. Topiramate is a sulfamate-substituted monosaccharide. It is freely soluble in dichloromethane. Topiramate oral solution is colorless to slightly yellow colored clear viscous liquid having berry flavor. Topiramate oral solution contains the following inactive ingredients: glycerin, methylparaben, mixed berry flavor, polyethylene glycol, propylparaben, propylene glycol, and sucralose."
},
{
"NDCCode": "17312-203-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17312-203-15) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17312-0203-15",
"ProductNDC": "17312-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Earache Drops",
"NonProprietaryName": "Atropa Belladonna, Anemone Pulsatilla, Lycopodium Clavatum Spore, Matricaria Chamomilla, And Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR",
"StrengthNumber": "30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-05-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0264-9379-88",
"PackageDescription": "10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE",
"NDC11Code": "00264-9379-88",
"ProductNDC": "0264-9379",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride With Dextrose",
"NonProprietaryName": "Bupivacaine Hydrochloride With Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "SUBARACHNOID",
"StartMarketingDate": "20190402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209087",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190402",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
"Description": "Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for Bupivacaine Hydrochloride in Dextrose Injection, USP is by subarachnoid injection. Bupivacaine Hydrochloride contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6- dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear and colorless sterile hyperbaric solution. Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. Bupivacaine Hydrochloride in Dextrose Injection, USP pH is between 4.0 and 6.5. The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives."
},
{
"NDCCode": "0409-1761-10",
"PackageDescription": "2 CELLO PACK in 1 CARTON (0409-1761-10) / 5 AMPULE in 1 CELLO PACK (0409-1761-05) / 2 mL in 1 AMPULE (0409-1761-18) ",
"NDC11Code": "00409-1761-10",
"ProductNDC": "0409-1761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine Spinal",
"NonProprietaryName": "Bupivacaine Hydrochloride In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBARACHNOID",
"StartMarketingDate": "20050519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018692",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
"Description": "MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O∙HCl∙H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of MARCAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. MARCAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of MARCAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. MARCAINE SPINAL does not contain any preservatives."
},
{
"NDCCode": "0409-1761-62",
"PackageDescription": "800 AMPULE in 1 CASE (0409-1761-62) / 2 mL in 1 AMPULE (0409-1761-18) ",
"NDC11Code": "00409-1761-62",
"ProductNDC": "0409-1761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine Spinal",
"NonProprietaryName": "Bupivacaine Hydrochloride In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBARACHNOID",
"StartMarketingDate": "20050519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018692",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050519",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
"Description": "MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O∙HCl∙H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of MARCAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. MARCAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of MARCAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. MARCAINE SPINAL does not contain any preservatives."
},
{
"NDCCode": "0409-3613-01",
"PackageDescription": "10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11) ",
"NDC11Code": "00409-3613-01",
"ProductNDC": "0409-3613",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine",
"ProprietaryNameSuffix": "Spinal",
"NonProprietaryName": "Bupivacaine Hydrochloride In Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBARACHNOID",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071810",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"SamplePackage": "N",
"IndicationAndUsage": "BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
"Description": "BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid injection. BUPIVACAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of BUPIVACAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. BUPIVACAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of BUPIVACAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. BUPIVACAINE SPINAL does not contain any preservatives."
},
{
"NDCCode": "16110-035-12",
"PackageDescription": "1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE",
"NDC11Code": "16110-0035-12",
"ProductNDC": "16110-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cordran",
"NonProprietaryName": "Flurandrenolide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19651018",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012806",
"LabelerName": "Almirall, LLC",
"SubstanceName": "FLURANDRENOLIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19651018",
"SamplePackage": "N",
"IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "16110-035-60",
"PackageDescription": "1 TUBE in 1 CARTON (16110-035-60) / 60 g in 1 TUBE",
"NDC11Code": "16110-0035-60",
"ProductNDC": "16110-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cordran",
"NonProprietaryName": "Flurandrenolide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19651018",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012806",
"LabelerName": "Almirall, LLC",
"SubstanceName": "FLURANDRENOLIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19651018",
"SamplePackage": "N",
"IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "16714-347-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0347-01",
"ProductNDC": "16714-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Philith",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20111222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090947",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111222",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-347-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0347-02",
"ProductNDC": "16714-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Philith",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20111222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090947",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111222",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-347-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0347-03",
"ProductNDC": "16714-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Philith",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20111222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090947",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111222",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-347-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0347-04",
"ProductNDC": "16714-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Philith",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol Tablets",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20111222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090947",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111222",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "27808-035-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (27808-035-01) ",
"NDC11Code": "27808-0035-01",
"ProductNDC": "27808-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202214",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141006",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "27808-035-02",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (27808-035-02) ",
"NDC11Code": "27808-0035-02",
"ProductNDC": "27808-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202214",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141006",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "27808-035-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (27808-035-03) ",
"NDC11Code": "27808-0035-03",
"ProductNDC": "27808-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202214",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141006",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "41520-035-36",
"PackageDescription": "36 TABLET, CHEWABLE in 1 BOTTLE (41520-035-36) ",
"NDC11Code": "41520-0035-36",
"ProductNDC": "41520-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Fruit Chews",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160622",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "American Sales",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160622",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Relieves. Heartburn. Sour stomach. Acid indigestion. Upset stomach due to these symptoms."
},
{
"NDCCode": "46708-508-17",
"PackageDescription": "1 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE",
"NDC11Code": "46708-0508-17",
"ProductNDC": "46708-508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bromfenac",
"NonProprietaryName": "Bromfenac",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210560",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "BROMFENAC SODIUM",
"StrengthNumber": "1.035",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221110",
"SamplePackage": "N",
"IndicationAndUsage": "Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.",
"Description": "Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C15H11BrNNaO3 3/2 H2O. The structural structure for bromfenac sodium is. Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.16. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg.Each mL of bromfenac ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035%Preservative: benzalkonium chloride (0.05 mg/mL)Inactives: boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). sodium hydroxide may be used to adjust pH and water for injection USP."
},
{
"NDCCode": "53747-035-00",
"PackageDescription": "1 BAG in 1 DRUM (53747-035-00) / 11 kg in 1 BAG",
"NDC11Code": "53747-0035-00",
"ProductNDC": "53747-035",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Unichem Laboratories Limited, India",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-10-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-SEP-11"
},
{
"NDCCode": "59368-035-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (59368-035-07) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59368-0035-07",
"ProductNDC": "59368-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyxambi",
"NonProprietaryName": "Empagliflozin And Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206073",
"LabelerName": "Praxis, LLC",
"SubstanceName": "EMPAGLIFLOZIN; LINAGLIPTIN",
"StrengthNumber": "10; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "59368-035-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59368-035-30) ",
"NDC11Code": "59368-0035-30",
"ProductNDC": "59368-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyxambi",
"NonProprietaryName": "Empagliflozin And Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206073",
"LabelerName": "Praxis, LLC",
"SubstanceName": "EMPAGLIFLOZIN; LINAGLIPTIN",
"StrengthNumber": "10; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "59368-035-39",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (59368-035-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59368-0035-39",
"ProductNDC": "59368-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyxambi",
"NonProprietaryName": "Empagliflozin And Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206073",
"LabelerName": "Praxis, LLC",
"SubstanceName": "EMPAGLIFLOZIN; LINAGLIPTIN",
"StrengthNumber": "10; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>17312-035-16</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (17312-035-16) > 8 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>17312-0035-16</NDC11Code>
<ProductNDC>17312-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smokers Nicotine Relief</ProprietaryName>
<NonProprietaryName>Aspidosperma Quebracho Blanco, Avena Sativa, Epinephrine, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Valerian, Wood Creosote</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150322</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; EPINEPHRINE; AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN</SubstanceName>
<StrengthNumber>6; 18; 18; 18; 9; 12; 18; 18; 18</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: cravings withdrawal irritability nicotine cleansing cough/lung support after diagnosis by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-036-16</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (17312-036-16) > 8 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>17312-0036-16</NDC11Code>
<ProductNDC>17312-036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smokers Appetite Relief</ProprietaryName>
<NonProprietaryName>Avena Sativa, Berberis Vulgaris, Capsicum, Fucus Vesiculosus, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Wood Creosote</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAPSICUM; MILK THISTLE; FUCUS VESICULOSUS; ST. JOHN'S WORT; WOOD CREOSOTE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>9; 12; 6; 6; 6; 6; 18; 12; 18</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>16729-035-16</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16) </PackageDescription>
<NDC11Code>16729-0035-16</NDC11Code>
<ProductNDC>16729-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090568</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43419-035-16</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (43419-035-16) > 11 g in 1 JAR</PackageDescription>
<NDC11Code>43419-0035-16</NDC11Code>
<ProductNDC>43419-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sulwhasoo Evenfair Compact No.24</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Amorepacific Corporation</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.22; 2.2</StrengthNumber>
<StrengthUnit>g/11g; g/11g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49035-035-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (49035-035-16) </PackageDescription>
<NDC11Code>49035-0035-16</NDC11Code>
<ProductNDC>49035-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Oil</ProprietaryName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<EndMarketingDate>20270828</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<EndMarketingDatePackage>20270828</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 6 to 8 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-035-16</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63776-035-16) </PackageDescription>
<NDC11Code>63776-0035-16</NDC11Code>
<ProductNDC>63776-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-035-16</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-16) </PackageDescription>
<NDC11Code>68382-0035-16</NDC11Code>
<ProductNDC>68382-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>69804-035-16</NDCCode>
<PackageDescription>113400 mg in 1 BOTTLE, DISPENSING (69804-035-16)</PackageDescription>
<NDC11Code>69804-0035-16</NDC11Code>
<ProductNDC>69804-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Naturally Hl Itch Relief</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>ridge properties</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>73069-035-16</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-16) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-16</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81033-035-16</NDCCode>
<PackageDescription>10 CUP, UNIT-DOSE in 1 CARTON (81033-035-16) / 8 mL in 1 CUP, UNIT-DOSE (81033-035-08) </PackageDescription>
<NDC11Code>81033-0035-16</NDC11Code>
<ProductNDC>81033-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217795</ApplicationNumber>
<LabelerName>Kesin Pharma</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate oral solution is indicated for: Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2). Preventive treatment of migraine in patients 12 years of age and older ( 1.3).</IndicationAndUsage>
<Description>Topiramate oral solution is available as a 25 mg/mL solution for oral administration. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate is a white to off white powder. Topiramate is a sulfamate-substituted monosaccharide. It is freely soluble in dichloromethane. Topiramate oral solution is colorless to slightly yellow colored clear viscous liquid having berry flavor. Topiramate oral solution contains the following inactive ingredients: glycerin, methylparaben, mixed berry flavor, polyethylene glycol, propylparaben, propylene glycol, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>17312-203-15</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17312-203-15) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17312-0203-15</NDC11Code>
<ProductNDC>17312-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Earache Drops</ProprietaryName>
<NonProprietaryName>Atropa Belladonna, Anemone Pulsatilla, Lycopodium Clavatum Spore, Matricaria Chamomilla, And Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0264-9379-88</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0264-9379-88) / 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00264-9379-88</NDC11Code>
<ProductNDC>0264-9379</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride With Dextrose</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride With Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBARACHNOID</RouteName>
<StartMarketingDate>20190402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209087</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for Bupivacaine Hydrochloride in Dextrose Injection, USP is by subarachnoid injection. Bupivacaine Hydrochloride contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6- dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear and colorless sterile hyperbaric solution. Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. Bupivacaine Hydrochloride in Dextrose Injection, USP pH is between 4.0 and 6.5. The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0409-1761-10</NDCCode>
<PackageDescription>2 CELLO PACK in 1 CARTON (0409-1761-10) / 5 AMPULE in 1 CELLO PACK (0409-1761-05) / 2 mL in 1 AMPULE (0409-1761-18) </PackageDescription>
<NDC11Code>00409-1761-10</NDC11Code>
<ProductNDC>0409-1761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine Spinal</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBARACHNOID</RouteName>
<StartMarketingDate>20050519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018692</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
<Description>MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O∙HCl∙H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of MARCAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. MARCAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of MARCAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. MARCAINE SPINAL does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0409-1761-62</NDCCode>
<PackageDescription>800 AMPULE in 1 CASE (0409-1761-62) / 2 mL in 1 AMPULE (0409-1761-18) </PackageDescription>
<NDC11Code>00409-1761-62</NDC11Code>
<ProductNDC>0409-1761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine Spinal</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBARACHNOID</RouteName>
<StartMarketingDate>20050519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018692</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
<Description>MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O∙HCl∙H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of MARCAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. MARCAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of MARCAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. MARCAINE SPINAL does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0409-3613-01</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11) </PackageDescription>
<NDC11Code>00409-3613-01</NDC11Code>
<ProductNDC>0409-3613</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine</ProprietaryName>
<ProprietaryNameSuffix>Spinal</ProprietaryNameSuffix>
<NonProprietaryName>Bupivacaine Hydrochloride In Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBARACHNOID</RouteName>
<StartMarketingDate>20050131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071810</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
<Description>BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid injection. BUPIVACAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of BUPIVACAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. BUPIVACAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of BUPIVACAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. BUPIVACAINE SPINAL does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>16110-035-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0035-12</NDC11Code>
<ProductNDC>16110-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cordran</ProprietaryName>
<NonProprietaryName>Flurandrenolide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19651018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012806</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>FLURANDRENOLIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19651018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>16110-035-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-035-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0035-60</NDC11Code>
<ProductNDC>16110-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cordran</ProprietaryName>
<NonProprietaryName>Flurandrenolide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19651018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012806</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>FLURANDRENOLIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19651018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>16714-347-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0347-01</NDC11Code>
<ProductNDC>16714-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Philith</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090947</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-347-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0347-02</NDC11Code>
<ProductNDC>16714-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Philith</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090947</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-347-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0347-03</NDC11Code>
<ProductNDC>16714-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Philith</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090947</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-347-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0347-04</NDC11Code>
<ProductNDC>16714-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Philith</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol Tablets</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090947</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>PHILITH 28-Day (Norethindrone and Ethinyl Estradiol tablets, USP)provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are. The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>27808-035-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (27808-035-01) </PackageDescription>
<NDC11Code>27808-0035-01</NDC11Code>
<ProductNDC>27808-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202214</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27808-035-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (27808-035-02) </PackageDescription>
<NDC11Code>27808-0035-02</NDC11Code>
<ProductNDC>27808-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202214</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>27808-035-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (27808-035-03) </PackageDescription>
<NDC11Code>27808-0035-03</NDC11Code>
<ProductNDC>27808-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202214</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O6 2 ½ H2O M.W. = 494.49. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. = 151.16. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>41520-035-36</NDCCode>
<PackageDescription>36 TABLET, CHEWABLE in 1 BOTTLE (41520-035-36) </PackageDescription>
<NDC11Code>41520-0035-36</NDC11Code>
<ProductNDC>41520-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antacid Fruit Chews</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160622</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>American Sales</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Relieves. Heartburn. Sour stomach. Acid indigestion. Upset stomach due to these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46708-508-17</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>46708-0508-17</NDC11Code>
<ProductNDC>46708-508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bromfenac</ProprietaryName>
<NonProprietaryName>Bromfenac</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20221110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210560</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>BROMFENAC SODIUM</SubstanceName>
<StrengthNumber>1.035</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.</IndicationAndUsage>
<Description>Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C15H11BrNNaO3 3/2 H2O. The structural structure for bromfenac sodium is. Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.16. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg.Each mL of bromfenac ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035%Preservative: benzalkonium chloride (0.05 mg/mL)Inactives: boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). sodium hydroxide may be used to adjust pH and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>53747-035-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (53747-035-00) / 11 kg in 1 BAG</PackageDescription>
<NDC11Code>53747-0035-00</NDC11Code>
<ProductNDC>53747-035</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Unichem Laboratories Limited, India</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-SEP-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59368-035-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59368-035-07) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59368-0035-07</NDC11Code>
<ProductNDC>59368-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyxambi</ProprietaryName>
<NonProprietaryName>Empagliflozin And Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206073</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>EMPAGLIFLOZIN; LINAGLIPTIN</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59368-035-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59368-035-30) </PackageDescription>
<NDC11Code>59368-0035-30</NDC11Code>
<ProductNDC>59368-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyxambi</ProprietaryName>
<NonProprietaryName>Empagliflozin And Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206073</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>EMPAGLIFLOZIN; LINAGLIPTIN</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59368-035-39</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (59368-035-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59368-0035-39</NDC11Code>
<ProductNDC>59368-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyxambi</ProprietaryName>
<NonProprietaryName>Empagliflozin And Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206073</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>EMPAGLIFLOZIN; LINAGLIPTIN</SubstanceName>
<StrengthNumber>10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>