{
"NDC": [
{
"NDCCode": "72162-1109-2",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (72162-1109-2) / 118 mL in 1 BOTTLE, GLASS",
"NDC11Code": "72162-1109-02",
"ProductNDC": "72162-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam Hydrochloride",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20050502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076379",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231025",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS].",
"Description": "Midazolam is a benzodiazepine available as midazolam HCl syrup for oral administration. Midazolam, a white to light yellow crystalline compound, is insoluble in water, but can be solubilized in aqueous solutions by formation of the hydrochloride salt in situ under acidic conditions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the molecular formula C18H13ClFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula. Each mL of the syrup contains midazolam hydrochloride equivalent to 2 mg midazolam compounded with artificial bitterness modifier, citric acid anhydrous, D&C Red #33, edetate disodium, glycerin, mixed fruit flavor, sodium benzoate, sodium citrate, sorbitol, and water; the pH is adjusted to 2.8 to 3.6 with hydrochloric acid. Under the acidic conditions required to solubilize midazolam in the syrup, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the syrup, the solution may contain up to about 40% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart below plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 2.8 to 3.6. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
},
{
"NDCCode": "36987-1109-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1109-2)",
"NDC11Code": "36987-1109-02",
"ProductNDC": "36987-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rat Epithelium",
"NonProprietaryName": "Rat Epithelium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "RATTUS NORVEGICUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [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": "37662-1109-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1109-2) ",
"NDC11Code": "37662-1109-02",
"ProductNDC": "37662-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Nitricum",
"NonProprietaryName": "Natrum Nitricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220729",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SODIUM NITRATE",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220729",
"SamplePackage": "N"
},
{
"NDCCode": "48951-1109-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-1109-2) ",
"NDC11Code": "48951-1109-02",
"ProductNDC": "48951-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Aurum 6/10",
"NonProprietaryName": "Arnica Aurum 6/10",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER",
"StrengthNumber": "6; 10; 4; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "50090-1109-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (50090-1109-2) ",
"NDC11Code": "50090-1109-02",
"ProductNDC": "50090-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077912",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
"StrengthNumber": "12.5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230421",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide."
},
{
"NDCCode": "51552-1109-2",
"PackageDescription": "12000 g in 1 CONTAINER (51552-1109-2) ",
"NDC11Code": "51552-1109-02",
"ProductNDC": "51552-1109",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Az Cream",
"DosageFormName": "CREAM",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "SAFFLOWER OIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "31-JAN-13"
},
{
"NDCCode": "52164-1109-1",
"PackageDescription": "1 KIT in 1 KIT (52164-1109-1) * .9 g in 1 PACKAGE (52124-0004-1) * .8 mL in 1 PACKAGE (52124-0001-1) * 10 mL in 1 BOTTLE (52124-0005-1) * .5 mL in 1 PACKAGE (52124-0002-1) * .5 mL in 1 PACKAGE (52124-0008-1) * 2 TABLET, CHEWABLE in 1 PACKAGE (52124-0012-1) * .5 g in 1 TUBE (52124-0003-1) * .9 g in 1 PACKAGE (52124-0006-1)",
"NDC11Code": "52164-1109-01",
"ProductNDC": "52164-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arc First Aid Emergency Preparedness Contains 167 Pieces",
"NonProprietaryName": "Benzalkonium Chloride, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Water, Isopropyl Alcohol, Benzocaine, Alcohol, Aspirin,",
"DosageFormName": "KIT",
"StartMarketingDate": "20100428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part344",
"LabelerName": "American Red Cross",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65372-1109-2",
"PackageDescription": "20 kg in 1 DRUM (65372-1109-2) ",
"NDC11Code": "65372-1109-02",
"ProductNDC": "65372-1109",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Olanzapine Form-1)",
"DosageFormName": "POWDER",
"StartMarketingDate": "20071023",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jubilant Biosys limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-30",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-OCT-07"
},
{
"NDCCode": "70518-1109-1",
"PackageDescription": "100 POUCH in 1 BOX (70518-1109-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-1109-2) ",
"NDC11Code": "70518-1109-01",
"ProductNDC": "70518-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205973",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200308",
"SamplePackage": "N"
},
{
"NDCCode": "70677-1109-2",
"PackageDescription": "238 g in 1 BOTTLE (70677-1109-2) ",
"NDC11Code": "70677-1109-02",
"ProductNDC": "70677-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foster And Thrive Clearlax",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090685",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "70771-1109-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2) ",
"NDC11Code": "70771-1109-04",
"ProductNDC": "70771-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204331",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1109-2",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1109-2) ",
"NDC11Code": "71335-1109-02",
"ProductNDC": "71335-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203562",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211220",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .",
"Description": "The potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, crystalline powder. It is odorless and has a saline taste. It is freely soluble in water and practically insoluble in ethanol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. This product complies with USP assay preparation 2. Inactive Ingredients: crospovidone, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and talc."
},
{
"NDCCode": "82969-1109-2",
"PackageDescription": "500000 mg in 1 JAR (82969-1109-2) ",
"NDC11Code": "82969-1109-02",
"ProductNDC": "82969-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bm Nat Mur",
"NonProprietaryName": "Natrium Muriaticum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Total Operations Management LLC DBA:Bestmade Natural Products Micro",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/60mg",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps temporarily relieve: imbalances related to dryness or excess moisture; loose stools, runny nose, vomiting, and painful urination; feelings of heaviness, coldness, fatigue, headaches, and weakness; and skin-related concerns."
},
{
"NDCCode": "0069-1109-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0069-1109-02) / 25 mL in 1 BOTTLE, GLASS (0069-1109-01) ",
"NDC11Code": "00069-1109-02",
"ProductNDC": "0069-1109",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Panzyga",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190809",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125587",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190809",
"SamplePackage": "N",
"Description": "Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "0409-1109-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1109-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1109-11) ",
"NDC11Code": "00409-1109-01",
"ProductNDC": "0409-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atracurium Besylate",
"NonProprietaryName": "Atracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090782",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130225",
"SamplePackage": "N",
"IndicationAndUsage": "Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.00 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2°C to 8°C (36°F to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if rerefrigerated."
},
{
"NDCCode": "50090-1109-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-1109-0) ",
"NDC11Code": "50090-1109-00",
"ProductNDC": "50090-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077912",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
"StrengthNumber": "12.5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide."
},
{
"NDCCode": "50090-1109-1",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-1109-1) ",
"NDC11Code": "50090-1109-01",
"ProductNDC": "50090-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077912",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
"StrengthNumber": "12.5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide."
},
{
"NDCCode": "72162-1000-2",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (72162-1000-2) ",
"NDC11Code": "72162-1000-02",
"ProductNDC": "72162-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209457",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl is indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. .",
"Description": "Icosapent ethyl, a lipid-regulating agent, is supplied as a 0.5 gram and 1 gram, liquid-filled soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl or 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Each capsule contains the following inactive ingredients: gelatin, glycerin, purified water, sorbitol, sorbitan and tocopherol. The monogramming ink ingredients contain: ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA alcohol (ethanol and ethyl acetate)."
},
{
"NDCCode": "72162-1048-2",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1048-2) / 45 g in 1 TUBE",
"NDC11Code": "72162-1048-02",
"ProductNDC": "72162-1048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090824",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240223",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene cream is indicated for the topical treatment of acne vulgaris.",
"Description": "Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.52. Adapalene is represented by the following structural formula:."
},
{
"NDCCode": "72162-1059-2",
"PackageDescription": "45 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-2) ",
"NDC11Code": "72162-1059-02",
"ProductNDC": "72162-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078056",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"Description": "Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-1071-2",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1071-2) / 45 g in 1 TUBE",
"NDC11Code": "72162-1071-02",
"ProductNDC": "72162-1071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190812",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017955",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Tretinoin Cream contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:."
},
{
"NDCCode": "72162-1072-2",
"PackageDescription": "1 TUBE in 1 CARTON (72162-1072-2) / 45 g in 1 TUBE",
"NDC11Code": "72162-1072-02",
"ProductNDC": "72162-1072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190712",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017579",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Tretinoin Cream contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:."
},
{
"NDCCode": "72162-1076-2",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-2) ",
"NDC11Code": "72162-1076-02",
"ProductNDC": "72162-1076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208864",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3."
},
{
"NDCCode": "72162-1085-2",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (72162-1085-2) ",
"NDC11Code": "72162-1085-02",
"ProductNDC": "72162-1085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrocloride",
"ProprietaryNameSuffix": "Dye-free, Sugar-free, Unflavored",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20201102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212093",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231005",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone Hydrochloride contains methadone, an opioid agonist indicated for the: 1 detoxification treatment of opioid addiction (heroin or other morphine-like drugs)., 2 maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Oral Concentrate, USP dye-free, sugar-free, unflavored contains methadone, an opioid agonist, and is available as a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptone hydrochloride. Methadone hydrochloride, USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in Methadone Hydrochloride as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its structural formula is C21H27NOHCl. This liquid concentrate contains 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone) per mL and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate."
},
{
"NDCCode": "72162-1098-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (72162-1098-2) / 50 mL in 1 BOTTLE",
"NDC11Code": "72162-1098-02",
"ProductNDC": "72162-1098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20070227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040710",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230926",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.",
"Description": "Lidocaine Hydrochloride Topical Solution USP, 4% contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Lidocaine Hydrochloride Topical Solution USP, 4% contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The 50 mL screw-cap bottle should not be autoclaved, because the closure employed cannot withstand autoclaving temperatures and pressures. Composition of Lidocaine Hydrochloride Topical Solution USP, 4%: Each mL contains lidocaine HCl, 40 mg, methylparaben, and sodium hydroxide and/or hydrochloric acid to adjust pH to 5.0 to 7.0. An aqueous solution. NOT FOR INJECTION."
},
{
"NDCCode": "72162-1108-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-2) ",
"NDC11Code": "72162-1108-02",
"ProductNDC": "72162-1108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091573",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231009",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium Chloride Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium chloride is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g per 2 mL. Each Trospium Chloride Tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, povidone, hypromellose, talc, stearic acid, titanium dioxide, colloidal silicon dioxide, magnesium stearate and polyethylene glycol 3350."
},
{
"NDCCode": "72162-1117-2",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (72162-1117-2) / 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "72162-1117-02",
"ProductNDC": "72162-1117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Podocon 25",
"NonProprietaryName": "Podophyllum Resin",
"DosageFormName": "TINCTURE",
"RouteName": "TOPICAL",
"StartMarketingDate": "19900901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PODOPHYLLUM RESIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/4mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata)(4).",
"Description": "Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne’), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see below)."
},
{
"NDCCode": "72162-1119-2",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (72162-1119-2) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "72162-1119-02",
"ProductNDC": "72162-1119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250402",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "72162-1123-2",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (72162-1123-2) ",
"NDC11Code": "72162-1123-02",
"ProductNDC": "72162-1123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205292",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "2; 30; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is a clear, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP ................. 2 mg. Pseudoephedrine Hydrochloride, USP ........ 30 mg. Dextromethorphan Hydrobromide, USP ...... 10 mg. Alcohol 0.95% v/v. In a palatable, aromatic vehicle. Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No. 40. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration."
},
{
"NDCCode": "72162-1124-2",
"PackageDescription": "15 g in 1 BOTTLE, PLASTIC (72162-1124-2) ",
"NDC11Code": "72162-1124-02",
"ProductNDC": "72162-1124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystop",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064118",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241224",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72162-1109-2</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (72162-1109-2) / 118 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>72162-1109-02</NDC11Code>
<ProductNDC>72162-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam Hydrochloride</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076379</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS].</IndicationAndUsage>
<Description>Midazolam is a benzodiazepine available as midazolam HCl syrup for oral administration. Midazolam, a white to light yellow crystalline compound, is insoluble in water, but can be solubilized in aqueous solutions by formation of the hydrochloride salt in situ under acidic conditions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the molecular formula C18H13ClFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula. Each mL of the syrup contains midazolam hydrochloride equivalent to 2 mg midazolam compounded with artificial bitterness modifier, citric acid anhydrous, D&C Red #33, edetate disodium, glycerin, mixed fruit flavor, sodium benzoate, sodium citrate, sorbitol, and water; the pH is adjusted to 2.8 to 3.6 with hydrochloric acid. Under the acidic conditions required to solubilize midazolam in the syrup, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the syrup, the solution may contain up to about 40% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart below plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 2.8 to 3.6. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
</NDC>
<NDC>
<NDCCode>36987-1109-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1109-2)</PackageDescription>
<NDC11Code>36987-1109-02</NDC11Code>
<ProductNDC>36987-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rat Epithelium</ProprietaryName>
<NonProprietaryName>Rat Epithelium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>RATTUS NORVEGICUS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [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>37662-1109-2</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-1109-2) </PackageDescription>
<NDC11Code>37662-1109-02</NDC11Code>
<ProductNDC>37662-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Nitricum</ProprietaryName>
<NonProprietaryName>Natrum Nitricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220729</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SODIUM NITRATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-1109-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-1109-2) </PackageDescription>
<NDC11Code>48951-1109-02</NDC11Code>
<ProductNDC>48951-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Aurum 6/10</ProprietaryName>
<NonProprietaryName>Arnica Aurum 6/10</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER</SubstanceName>
<StrengthNumber>6; 10; 4; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1109-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-1109-2) </PackageDescription>
<NDC11Code>50090-1109-02</NDC11Code>
<ProductNDC>50090-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077912</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LISINOPRIL</SubstanceName>
<StrengthNumber>12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>51552-1109-2</NDCCode>
<PackageDescription>12000 g in 1 CONTAINER (51552-1109-2) </PackageDescription>
<NDC11Code>51552-1109-02</NDC11Code>
<ProductNDC>51552-1109</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Az Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>SAFFLOWER OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-JAN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52164-1109-1</NDCCode>
<PackageDescription>1 KIT in 1 KIT (52164-1109-1) * .9 g in 1 PACKAGE (52124-0004-1) * .8 mL in 1 PACKAGE (52124-0001-1) * 10 mL in 1 BOTTLE (52124-0005-1) * .5 mL in 1 PACKAGE (52124-0002-1) * .5 mL in 1 PACKAGE (52124-0008-1) * 2 TABLET, CHEWABLE in 1 PACKAGE (52124-0012-1) * .5 g in 1 TUBE (52124-0003-1) * .9 g in 1 PACKAGE (52124-0006-1)</PackageDescription>
<NDC11Code>52164-1109-01</NDC11Code>
<ProductNDC>52164-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arc First Aid Emergency Preparedness Contains 167 Pieces</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Water, Isopropyl Alcohol, Benzocaine, Alcohol, Aspirin,</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part344</ApplicationNumber>
<LabelerName>American Red Cross</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65372-1109-2</NDCCode>
<PackageDescription>20 kg in 1 DRUM (65372-1109-2) </PackageDescription>
<NDC11Code>65372-1109-02</NDC11Code>
<ProductNDC>65372-1109</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Olanzapine Form-1)</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20071023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jubilant Biosys limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-30</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-07</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70518-1109-1</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-1109-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-1109-2) </PackageDescription>
<NDC11Code>70518-1109-01</NDC11Code>
<ProductNDC>70518-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205973</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70677-1109-2</NDCCode>
<PackageDescription>238 g in 1 BOTTLE (70677-1109-2) </PackageDescription>
<NDC11Code>70677-1109-02</NDC11Code>
<ProductNDC>70677-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foster And Thrive Clearlax</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090685</ApplicationNumber>
<LabelerName>Strategic Sourcing Services LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70771-1109-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2) </PackageDescription>
<NDC11Code>70771-1109-04</NDC11Code>
<ProductNDC>70771-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204331</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1109-2</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1109-2) </PackageDescription>
<NDC11Code>71335-1109-02</NDC11Code>
<ProductNDC>71335-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203562</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
<Description>The potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, crystalline powder. It is odorless and has a saline taste. It is freely soluble in water and practically insoluble in ethanol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. This product complies with USP assay preparation 2. Inactive Ingredients: crospovidone, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and talc.</Description>
</NDC>
<NDC>
<NDCCode>82969-1109-2</NDCCode>
<PackageDescription>500000 mg in 1 JAR (82969-1109-2) </PackageDescription>
<NDC11Code>82969-1109-02</NDC11Code>
<ProductNDC>82969-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bm Nat Mur</ProprietaryName>
<NonProprietaryName>Natrium Muriaticum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Total Operations Management LLC DBA:Bestmade Natural Products Micro</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/60mg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps temporarily relieve: imbalances related to dryness or excess moisture; loose stools, runny nose, vomiting, and painful urination; feelings of heaviness, coldness, fatigue, headaches, and weakness; and skin-related concerns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-1109-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0069-1109-02) / 25 mL in 1 BOTTLE, GLASS (0069-1109-01) </PackageDescription>
<NDC11Code>00069-1109-02</NDC11Code>
<ProductNDC>0069-1109</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Panzyga</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190809</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125587</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 4% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>0409-1109-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1109-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1109-11) </PackageDescription>
<NDC11Code>00409-1109-01</NDC11Code>
<ProductNDC>0409-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atracurium Besylate</ProprietaryName>
<NonProprietaryName>Atracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090782</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Atracurium besylate is an intermediate-duration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate is designated as 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester. It has a molecular weight of 1243.49, and its molecular formula is C65H82N2O18S2. The structural formula is. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. The symmetry of the molecule, however, results in only ten, instead of sixteen, possible different isomers. The manufacture of atracurium besylate results in these isomers being produced in unequal amounts but with a consistent ratio. Those molecules in which the methyl group attached to the quaternary nitrogen projects on the opposite side to the adjacent substituted-benzyl moiety predominate by approximately 3:1. Atracurium Besylate Injection USP is a sterile, non-pyrogenic aqueous solution. Each mL contains 10 mg atracurium besylate. The pH is adjusted to 3.00 to 3.65 with benzenesulfonic acid. The multiple dose vial contains 0.9% benzyl alcohol added as a preservative. Atracurium besylate injection slowly loses potency with time at the rate of approximately 6% per year under refrigeration (5°C). Atracurium besylate injection should be refrigerated at 2°C to 8°C (36°F to 46°F) to preserve potency. Rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use atracurium besylate injection within 14 days even if rerefrigerated.</Description>
</NDC>
<NDC>
<NDCCode>50090-1109-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-1109-0) </PackageDescription>
<NDC11Code>50090-1109-00</NDC11Code>
<ProductNDC>50090-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077912</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LISINOPRIL</SubstanceName>
<StrengthNumber>12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1109-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-1109-1) </PackageDescription>
<NDC11Code>50090-1109-01</NDC11Code>
<ProductNDC>50090-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077912</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LISINOPRIL</SubstanceName>
<StrengthNumber>12.5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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 is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>72162-1000-2</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (72162-1000-2) </PackageDescription>
<NDC11Code>72162-1000-02</NDC11Code>
<ProductNDC>72162-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209457</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl is indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. .</IndicationAndUsage>
<Description>Icosapent ethyl, a lipid-regulating agent, is supplied as a 0.5 gram and 1 gram, liquid-filled soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl or 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Each capsule contains the following inactive ingredients: gelatin, glycerin, purified water, sorbitol, sorbitan and tocopherol. The monogramming ink ingredients contain: ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA alcohol (ethanol and ethyl acetate).</Description>
</NDC>
<NDC>
<NDCCode>72162-1048-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1048-2) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1048-02</NDC11Code>
<ProductNDC>72162-1048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090824</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene cream is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.52. Adapalene is represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>72162-1059-2</NDCCode>
<PackageDescription>45 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1059-2) </PackageDescription>
<NDC11Code>72162-1059-02</NDC11Code>
<ProductNDC>72162-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078056</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Alprazolam extended-release tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented below. Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-1071-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1071-2) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1071-02</NDC11Code>
<ProductNDC>72162-1071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190812</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017955</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Tretinoin Cream contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>72162-1072-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-1072-2) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-1072-02</NDC11Code>
<ProductNDC>72162-1072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190712</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017579</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 90% w/w. Tretinoin Cream contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>72162-1076-2</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1076-2) </PackageDescription>
<NDC11Code>72162-1076-02</NDC11Code>
<ProductNDC>72162-1076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208864</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release capsules, USP, are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, gelatin, magnesium stearate, sodium lauryl sulfate, titanium dioxide and edible black ink. The 10 mEq capsules also contain black iron oxide, FD&C blue No.1 and FD&C red No.3.</Description>
</NDC>
<NDC>
<NDCCode>72162-1085-2</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (72162-1085-2) </PackageDescription>
<NDC11Code>72162-1085-02</NDC11Code>
<ProductNDC>72162-1085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrocloride</ProprietaryName>
<ProprietaryNameSuffix>Dye-free, Sugar-free, Unflavored</ProprietaryNameSuffix>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212093</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone Hydrochloride contains methadone, an opioid agonist indicated for the: 1 detoxification treatment of opioid addiction (heroin or other morphine-like drugs)., 2 maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Oral Concentrate, USP dye-free, sugar-free, unflavored contains methadone, an opioid agonist, and is available as a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptone hydrochloride. Methadone hydrochloride, USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in Methadone Hydrochloride as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its structural formula is C21H27NOHCl. This liquid concentrate contains 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone) per mL and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>72162-1098-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72162-1098-2) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72162-1098-02</NDC11Code>
<ProductNDC>72162-1098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040710</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Topical Solution USP, 4% contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Lidocaine Hydrochloride Topical Solution USP, 4% contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The 50 mL screw-cap bottle should not be autoclaved, because the closure employed cannot withstand autoclaving temperatures and pressures. Composition of Lidocaine Hydrochloride Topical Solution USP, 4%: Each mL contains lidocaine HCl, 40 mg, methylparaben, and sodium hydroxide and/or hydrochloric acid to adjust pH to 5.0 to 7.0. An aqueous solution. NOT FOR INJECTION.</Description>
</NDC>
<NDC>
<NDCCode>72162-1108-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-2) </PackageDescription>
<NDC11Code>72162-1108-02</NDC11Code>
<ProductNDC>72162-1108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091573</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium Chloride Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium chloride is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound's solubility in water is approximately 1 g per 2 mL. Each Trospium Chloride Tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, povidone, hypromellose, talc, stearic acid, titanium dioxide, colloidal silicon dioxide, magnesium stearate and polyethylene glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>72162-1117-2</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (72162-1117-2) / 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>72162-1117-02</NDC11Code>
<ProductNDC>72162-1117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Podocon 25</ProprietaryName>
<NonProprietaryName>Podophyllum Resin</NonProprietaryName>
<DosageFormName>TINCTURE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19900901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PODOPHYLLUM RESIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata)(4).</IndicationAndUsage>
<Description>Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne’), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see below).</Description>
</NDC>
<NDC>
<NDCCode>72162-1119-2</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (72162-1119-2) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>72162-1119-02</NDC11Code>
<ProductNDC>72162-1119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>72162-1123-2</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (72162-1123-2) </PackageDescription>
<NDC11Code>72162-1123-02</NDC11Code>
<ProductNDC>72162-1123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205292</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>2; 30; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup is a clear, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains. Brompheniramine Maleate, USP ................. 2 mg. Pseudoephedrine Hydrochloride, USP ........ 30 mg. Dextromethorphan Hydrobromide, USP ...... 10 mg. Alcohol 0.95% v/v. In a palatable, aromatic vehicle. Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No. 40. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>72162-1124-2</NDCCode>
<PackageDescription>15 g in 1 BOTTLE, PLASTIC (72162-1124-2) </PackageDescription>
<NDC11Code>72162-1124-02</NDC11Code>
<ProductNDC>72162-1124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystop</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064118</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
</NDCList>