{
"NDC": [
{
"NDCCode": "71603-1700-0",
"PackageDescription": "142 g in 1 TUBE (71603-1700-0)",
"NDC11Code": "71603-1700-00",
"ProductNDC": "71603-1700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cleanafnaturalanticavitytoothpaste",
"NonProprietaryName": "Sodium Fluroide Paste, Dentrifice",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20170717",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "CLEANAF GLOBAL LIMITED LIABILITY COMPANY",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".22",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "12502-1700-0",
"PackageDescription": "50 kg in 1 DRUM (12502-1700-0)",
"NDC11Code": "12502-1700-00",
"ProductNDC": "12502-1700",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "POWDER",
"StartMarketingDate": "19990824",
"EndMarketingDate": "20150330",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Cilag AG",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20150330"
},
{
"NDCCode": "50923-0488-0",
"PackageDescription": "1700 g in 1 CONTAINER (50923-0488-0)",
"NDC11Code": "50923-0488-00",
"ProductNDC": "50923-0488",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Czt-4",
"DosageFormName": "POWDER",
"StartMarketingDate": "20091028",
"EndMarketingDate": "20150630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Ajinomoto Omnichem N.V.",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20150630"
},
{
"NDCCode": "54868-1700-0",
"PackageDescription": "120 TABLET in 1 BOTTLE (54868-1700-0)",
"NDC11Code": "54868-1700-00",
"ProductNDC": "54868-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "55566-1501-1",
"PackageDescription": "1 KIT in 1 CARTON (55566-1501-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) ",
"NDC11Code": "55566-1501-01",
"ProductNDC": "55566-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novarel",
"NonProprietaryName": "Gonadotrophin, Chorionic",
"DosageFormName": "KIT",
"StartMarketingDate": "19740115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA017016",
"LabelerName": "Ferring Pharmaceuticals Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19740115",
"SamplePackage": "N",
"IndicationAndUsage": "HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR \"NORMAL\" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.",
"Description": "Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg."
},
{
"NDCCode": "55566-1502-1",
"PackageDescription": "1 KIT in 1 CARTON (55566-1502-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) ",
"NDC11Code": "55566-1502-01",
"ProductNDC": "55566-1502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novarel",
"NonProprietaryName": "Gonadotrophin, Chorionic",
"DosageFormName": "KIT",
"StartMarketingDate": "20170830",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA017016",
"LabelerName": "Ferring Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170830",
"SamplePackage": "N",
"IndicationAndUsage": "HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR \"NORMAL\" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.",
"Description": "Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg."
},
{
"NDCCode": "55714-1700-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1700-0)",
"NDC11Code": "55714-1700-00",
"ProductNDC": "55714-1700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Detoxifier",
"NonProprietaryName": "Uricum Acidum, Benzoicum Acidum, Berber. Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Carduus Mar., Cynara Scolymus, Solidago",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Detoxifier Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination."
},
{
"NDCCode": "64918-1700-0",
"PackageDescription": "20 kg in 1 BOX (64918-1700-0) ",
"NDC11Code": "64918-1700-00",
"ProductNDC": "64918-1700",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151117",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Sterling S.p.A.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-10-08",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "17-NOV-15"
},
{
"NDCCode": "70518-1700-0",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-1700-0) ",
"NDC11Code": "70518-1700-00",
"ProductNDC": "70518-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181129",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1700-0",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-0) ",
"NDC11Code": "70710-1700-00",
"ProductNDC": "70710-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230518",
"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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13."
},
{
"NDCCode": "72162-1700-0",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72162-1700-0) ",
"NDC11Code": "72162-1700-00",
"ProductNDC": "72162-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201845",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "100; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121030",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
"Description": "Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "76278-1700-0",
"PackageDescription": "25 kg in 1 DRUM (76278-1700-0) ",
"NDC11Code": "76278-1700-00",
"ProductNDC": "76278-1700",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fosfomycin Trometamol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Clarochem Ireland Ltd.",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-04-10",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "31-MAR-25"
},
{
"NDCCode": "76370-0013-0",
"PackageDescription": "1700 APPLICATOR in 1 POUCH (76370-0013-0) / 1.3 mL in 1 APPLICATOR",
"NDC11Code": "76370-0013-00",
"ProductNDC": "76370-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tazza",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210609",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Tazza Brands East Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210609",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 to decrease bacteria on the skin, 2 recommended for repeated use."
},
{
"NDCCode": "25000-105-42",
"PackageDescription": "1700 CAPSULE in 1 BAG (25000-105-42) ",
"NDC11Code": "25000-0105-42",
"ProductNDC": "25000-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin Capsules, USP is gabapentin,USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Capsules, USP contain 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue # 1 Aluminum Lake, propylene glycol, titanium dioxide and shellac."
},
{
"NDCCode": "36987-1700-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1700-1)",
"NDC11Code": "36987-1700-01",
"ProductNDC": "36987-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Horseradish",
"NonProprietaryName": "Horseradish",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "HORSERADISH",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1700-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1700-2)",
"NDC11Code": "36987-1700-02",
"ProductNDC": "36987-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Horseradish",
"NonProprietaryName": "Horseradish",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "HORSERADISH",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1700-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1700-3)",
"NDC11Code": "36987-1700-03",
"ProductNDC": "36987-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Horseradish",
"NonProprietaryName": "Horseradish",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "HORSERADISH",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1700-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1700-4)",
"NDC11Code": "36987-1700-04",
"ProductNDC": "36987-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Horseradish",
"NonProprietaryName": "Horseradish",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "HORSERADISH",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "49672-100-01",
"PackageDescription": "125 mL in 1 PACKAGE (49672-100-01)",
"NDC11Code": "49672-0100-01",
"ProductNDC": "49672-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Techniblock Ultra Sunscreen",
"NonProprietaryName": "Avobenzone,octinoxate,oxybenzone,padimate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100405",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Myles Group LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A",
"StrengthNumber": ".6; 6.3; 3.4; 5.1",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. Helps prevent Sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.",
"Description": "See base of tin for batch detailsThis product has a security tab on either side of thedust cover. Do not use if these tabs are broken,missing or have been tampered with. Manufactured by:Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA. Distributed By:The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA."
},
{
"NDCCode": "51662-1700-1",
"PackageDescription": "1 mL in 1 VIAL, SINGLE-DOSE (51662-1700-1) ",
"NDC11Code": "51662-1700-01",
"ProductNDC": "51662-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol",
"NonProprietaryName": "Propranolol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075826",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010907",
"SamplePackage": "N",
"IndicationAndUsage": "Cardiac Arrhythmias. Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1. Supraventricular arrhythmias. Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff-Parkinson-White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2. Ventricular tachycardias. With the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some sympathetic drive for maintenance of myocardial tone (see DOSAGE AND ADMINISTRATION). Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias. Intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well-being of the patient and do not respond to conventional measures. 3. Tachyarrhythmias of digitalis intoxication. Intravenous propranolol is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur (see OVERDOSAGE). 4. Resistant tachyarrhythmias due to excessive catecholamine action during anesthesia. Intravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when propranolol is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure (see WARNINGS).",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)- 1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is. C16H21NO2 HCl M.W. 295.80 Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Propranolol Hydrochloride Injection, USP is available as a 1 mg/mL sterile injectable solution for intravenous administration. Each mL contains 1 mg of propranolol hydrochloride in Water for Injection. The pH is adjusted to 2.8 to 4.0 with citric acid monohydrate."
},
{
"NDCCode": "59088-156-54",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) ",
"NDC11Code": "59088-0156-54",
"ProductNDC": "59088-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Menatrol",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE",
"StrengthNumber": "1.5; 600; 1000; 100; 4; 220",
"StrengthUnit": "mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.",
"Description": "Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg."
},
{
"NDCCode": "65862-524-31",
"PackageDescription": "1700 TABLET, FILM COATED in 1 BOTTLE (65862-524-31) ",
"NDC11Code": "65862-0524-31",
"ProductNDC": "65862-524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200651",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111006",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "70710-1700-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-3) ",
"NDC11Code": "70710-1700-03",
"ProductNDC": "70710-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230518",
"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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13."
},
{
"NDCCode": "70710-1700-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1700-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70710-1700-2) ",
"NDC11Code": "70710-1700-04",
"ProductNDC": "70710-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230518",
"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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13."
},
{
"NDCCode": "70710-1700-5",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-5) ",
"NDC11Code": "70710-1700-05",
"ProductNDC": "70710-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230518",
"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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13."
},
{
"NDCCode": "70710-1700-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-9) ",
"NDC11Code": "70710-1700-09",
"ProductNDC": "70710-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230518",
"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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13."
},
{
"NDCCode": "0115-1700-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0115-1700-01) ",
"NDC11Code": "00115-1700-01",
"ProductNDC": "0115-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040646",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070330",
"SamplePackage": "N",
"Description": "Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white or practically white, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.5 g/mol and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "0280-0016-01",
"PackageDescription": "18 POUCH in 1 BOX (0280-0016-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0016-01",
"ProductNDC": "0280-0016",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Anhydrous Citric Acid, Sodium Bicarbonate, Aspirin",
"DosageFormName": "TABLET, EFFERVESCENT",
"StartMarketingDate": "20141107",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE",
"StrengthNumber": "1000; 325; 1700",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "07-NOV-14"
},
{
"NDCCode": "0280-4020-36",
"PackageDescription": "18 POUCH in 1 CARTON (0280-4020-36) > 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-4020-36",
"ProductNDC": "0280-4020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Lemon Lime",
"NonProprietaryName": "Alka-seltzer Lemon Lime",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20141107",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE",
"StrengthNumber": "1000; 325; 1700",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141107",
"SamplePackage": "N"
},
{
"NDCCode": "0378-1700-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-01) ",
"NDC11Code": "00378-1700-01",
"ProductNDC": "0378-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin (macrocrystals)",
"NonProprietaryName": "Nitrofurantoin (macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040921",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077025",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040921",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
}
]
}
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<PackageDescription>142 g in 1 TUBE (71603-1700-0)</PackageDescription>
<NDC11Code>71603-1700-00</NDC11Code>
<ProductNDC>71603-1700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cleanafnaturalanticavitytoothpaste</ProprietaryName>
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<StrengthNumber>.22</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<PackageDescription>50 kg in 1 DRUM (12502-1700-0)</PackageDescription>
<NDC11Code>12502-1700-00</NDC11Code>
<ProductNDC>12502-1700</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19990824</StartMarketingDate>
<EndMarketingDate>20150330</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cilag AG</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20150330</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50923-0488-0</NDCCode>
<PackageDescription>1700 g in 1 CONTAINER (50923-0488-0)</PackageDescription>
<NDC11Code>50923-0488-00</NDC11Code>
<ProductNDC>50923-0488</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Czt-4</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20091028</StartMarketingDate>
<EndMarketingDate>20150630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Ajinomoto Omnichem N.V.</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20150630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-1700-0</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (54868-1700-0)</PackageDescription>
<NDC11Code>54868-1700-00</NDC11Code>
<ProductNDC>54868-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2 Acetaminophen USP ........................................................................................325 mg , 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>55566-1501-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (55566-1501-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) </PackageDescription>
<NDC11Code>55566-1501-01</NDC11Code>
<ProductNDC>55566-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novarel</ProprietaryName>
<NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19740115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA017016</ApplicationNumber>
<LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.</IndicationAndUsage>
<Description>Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.</Description>
</NDC>
<NDC>
<NDCCode>55566-1502-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (55566-1502-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) </PackageDescription>
<NDC11Code>55566-1502-01</NDC11Code>
<ProductNDC>55566-1502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novarel</ProprietaryName>
<NonProprietaryName>Gonadotrophin, Chorionic</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170830</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA017016</ApplicationNumber>
<LabelerName>Ferring Pharmaceuticals Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. : 1 Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9., 2 Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males., 3 Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.</IndicationAndUsage>
<Description>Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains. chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains. chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.</Description>
</NDC>
<NDC>
<NDCCode>55714-1700-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1700-0)</PackageDescription>
<NDC11Code>55714-1700-00</NDC11Code>
<ProductNDC>55714-1700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Detoxifier</ProprietaryName>
<NonProprietaryName>Uricum Acidum, Benzoicum Acidum, Berber. Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Carduus Mar., Cynara Scolymus, Solidago</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Detoxifier Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64918-1700-0</NDCCode>
<PackageDescription>20 kg in 1 BOX (64918-1700-0) </PackageDescription>
<NDC11Code>64918-1700-00</NDC11Code>
<ProductNDC>64918-1700</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151117</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Sterling S.p.A.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-10-08</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-NOV-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70518-1700-0</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-1700-0) </PackageDescription>
<NDC11Code>70518-1700-00</NDC11Code>
<ProductNDC>70518-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1700-0</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-0) </PackageDescription>
<NDC11Code>70710-1700-00</NDC11Code>
<ProductNDC>70710-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230518</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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>72162-1700-0</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72162-1700-0) </PackageDescription>
<NDC11Code>72162-1700-00</NDC11Code>
<ProductNDC>72162-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201845</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>100; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).</IndicationAndUsage>
<Description>Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>76278-1700-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (76278-1700-0) </PackageDescription>
<NDC11Code>76278-1700-00</NDC11Code>
<ProductNDC>76278-1700</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fosfomycin Trometamol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Clarochem Ireland Ltd.</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-10</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAR-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>76370-0013-0</NDCCode>
<PackageDescription>1700 APPLICATOR in 1 POUCH (76370-0013-0) / 1.3 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>76370-0013-00</NDC11Code>
<ProductNDC>76370-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tazza</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Tazza Brands East Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 to decrease bacteria on the skin, 2 recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25000-105-42</NDCCode>
<PackageDescription>1700 CAPSULE in 1 BAG (25000-105-42) </PackageDescription>
<NDC11Code>25000-0105-42</NDC11Code>
<ProductNDC>25000-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090007</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin Capsules, USP is gabapentin,USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Capsules, USP contain 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue # 1 Aluminum Lake, propylene glycol, titanium dioxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>36987-1700-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1700-1)</PackageDescription>
<NDC11Code>36987-1700-01</NDC11Code>
<ProductNDC>36987-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Horseradish</ProprietaryName>
<NonProprietaryName>Horseradish</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>HORSERADISH</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1700-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1700-2)</PackageDescription>
<NDC11Code>36987-1700-02</NDC11Code>
<ProductNDC>36987-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Horseradish</ProprietaryName>
<NonProprietaryName>Horseradish</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>HORSERADISH</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1700-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1700-3)</PackageDescription>
<NDC11Code>36987-1700-03</NDC11Code>
<ProductNDC>36987-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Horseradish</ProprietaryName>
<NonProprietaryName>Horseradish</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>HORSERADISH</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1700-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1700-4)</PackageDescription>
<NDC11Code>36987-1700-04</NDC11Code>
<ProductNDC>36987-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Horseradish</ProprietaryName>
<NonProprietaryName>Horseradish</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>HORSERADISH</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>49672-100-01</NDCCode>
<PackageDescription>125 mL in 1 PACKAGE (49672-100-01)</PackageDescription>
<NDC11Code>49672-0100-01</NDC11Code>
<ProductNDC>49672-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Techniblock Ultra Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone,octinoxate,oxybenzone,padimate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>The Myles Group LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A</SubstanceName>
<StrengthNumber>.6; 6.3; 3.4; 5.1</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. Helps prevent Sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
<Description>See base of tin for batch detailsThis product has a security tab on either side of thedust cover. Do not use if these tabs are broken,missing or have been tampered with. Manufactured by:Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA. Distributed By:The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA.</Description>
</NDC>
<NDC>
<NDCCode>51662-1700-1</NDCCode>
<PackageDescription>1 mL in 1 VIAL, SINGLE-DOSE (51662-1700-1) </PackageDescription>
<NDC11Code>51662-1700-01</NDC11Code>
<ProductNDC>51662-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol</ProprietaryName>
<NonProprietaryName>Propranolol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075826</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cardiac Arrhythmias. Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1. Supraventricular arrhythmias. Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff-Parkinson-White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2. Ventricular tachycardias. With the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some sympathetic drive for maintenance of myocardial tone (see DOSAGE AND ADMINISTRATION). Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias. Intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well-being of the patient and do not respond to conventional measures. 3. Tachyarrhythmias of digitalis intoxication. Intravenous propranolol is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur (see OVERDOSAGE). 4. Resistant tachyarrhythmias due to excessive catecholamine action during anesthesia. Intravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when propranolol is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure (see WARNINGS).</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)- 1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is. C16H21NO2 HCl M.W. 295.80 Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Propranolol Hydrochloride Injection, USP is available as a 1 mg/mL sterile injectable solution for intravenous administration. Each mL contains 1 mg of propranolol hydrochloride in Water for Injection. The pH is adjusted to 2.8 to 4.0 with citric acid monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>59088-156-54</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (59088-156-54) </PackageDescription>
<NDC11Code>59088-0156-54</NDC11Code>
<ProductNDC>59088-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Menatrol</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; RHUBARB; CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1.5; 600; 1000; 100; 4; 220</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.</IndicationAndUsage>
<Description>Full Prescribing Information:Drug Description:Menatrol Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:. Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages. Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily. Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ. Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance. Each capsule contains: Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU) Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate) Calcium (as Calcium Carbonate)..................................220 mg Magnesium (as Magnesium Oxide)..............................100 mg Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg.</Description>
</NDC>
<NDC>
<NDCCode>65862-524-31</NDCCode>
<PackageDescription>1700 TABLET, FILM COATED in 1 BOTTLE (65862-524-31) </PackageDescription>
<NDC11Code>65862-0524-31</NDC11Code>
<ProductNDC>65862-524</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200651</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>70710-1700-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-3) </PackageDescription>
<NDC11Code>70710-1700-03</NDC11Code>
<ProductNDC>70710-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230518</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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>70710-1700-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1700-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70710-1700-2) </PackageDescription>
<NDC11Code>70710-1700-04</NDC11Code>
<ProductNDC>70710-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230518</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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>70710-1700-5</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-5) </PackageDescription>
<NDC11Code>70710-1700-05</NDC11Code>
<ProductNDC>70710-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230518</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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>70710-1700-9</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1700-9) </PackageDescription>
<NDC11Code>70710-1700-09</NDC11Code>
<ProductNDC>70710-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230518</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 SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] 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: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>0115-1700-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0115-1700-01) </PackageDescription>
<NDC11Code>00115-1700-01</NDC11Code>
<ProductNDC>0115-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040646</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white or practically white, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.5 g/mol and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0280-0016-01</NDCCode>
<PackageDescription>18 POUCH in 1 BOX (0280-0016-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0016-01</NDC11Code>
<ProductNDC>0280-0016</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Anhydrous Citric Acid, Sodium Bicarbonate, Aspirin</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<StartMarketingDate>20141107</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1000; 325; 1700</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-NOV-14</StartMarketingDatePackage>
</NDC>
<NDC>
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<NDC11Code>00280-4020-36</NDC11Code>
<ProductNDC>0280-4020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Lemon Lime</ProprietaryName>
<NonProprietaryName>Alka-seltzer Lemon Lime</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20141107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1000; 325; 1700</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0378-1700-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-01) </PackageDescription>
<NDC11Code>00378-1700-01</NDC11Code>
<ProductNDC>0378-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040921</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077025</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040921</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>