{
"NDC": [
{
"NDCCode": "0536-1108-52",
"PackageDescription": "7 PATCH in 1 CARTON (0536-1108-52) / 24 h in 1 PATCH",
"NDC11Code": "00536-1108-52",
"ProductNDC": "0536-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 1",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "21",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0536-1108-71",
"PackageDescription": "28 PATCH in 1 CARTON (0536-1108-71) / 24 h in 1 PATCH",
"NDC11Code": "00536-1108-71",
"ProductNDC": "0536-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 1",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "21",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0536-1108-88",
"PackageDescription": "14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH",
"NDC11Code": "00536-1108-88",
"ProductNDC": "0536-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 1",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "21",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0536-1106-52",
"PackageDescription": "7 PATCH in 1 CARTON (0536-1106-52) / 24 h in 1 PATCH",
"NDC11Code": "00536-1106-52",
"ProductNDC": "0536-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 3",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "7",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0536-1107-52",
"PackageDescription": "7 PATCH in 1 CARTON (0536-1107-52) / 24 h in 1 PATCH",
"NDC11Code": "00536-1107-52",
"ProductNDC": "0536-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 2",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "NICOTINE",
"StrengthNumber": "14",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "51655-536-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, DISPENSING (51655-536-52)",
"NDC11Code": "51655-0536-52",
"ProductNDC": "51655-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Northwind Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).",
"Description": "Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "0536-1500-60",
"PackageDescription": "160 CAPSULE in 1 BOTTLE (0536-1500-60) ",
"NDC11Code": "00536-1500-60",
"ProductNDC": "0536-1500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Reguloid",
"NonProprietaryName": "Psyllium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100428",
"EndMarketingDate": "20191130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": ".52",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100428",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "16714-536-01",
"PackageDescription": "1 VIAL in 1 CARTON (16714-536-01) / 1 mL in 1 VIAL",
"NDC11Code": "16714-0536-01",
"ProductNDC": "16714-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220810",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210246",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220810",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
"Description": "Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid, NF and/or sodium hydroxide, NF.For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: Pyrrolidinium, 3-[(SR)-cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, [RS-] bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33 g/mol. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "16714-536-25",
"PackageDescription": "25 VIAL in 1 CARTON (16714-536-25) / 1 mL in 1 VIAL",
"NDC11Code": "16714-0536-25",
"ProductNDC": "16714-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220810",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210246",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220810",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
"Description": "Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid, NF and/or sodium hydroxide, NF.For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: Pyrrolidinium, 3-[(SR)-cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, [RS-] bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33 g/mol. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "53808-0536-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0536-1)",
"NDC11Code": "53808-0536-01",
"ProductNDC": "53808-0536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.",
"Description": "Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG- CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula:. C23 H35 NaO7 MW 446.52. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C Yellow No 10 Aluminium Lake and the 40 mg tablet also contains D&C Yellow No 10 Aluminium Lake and FD&C Blue No. 1-Aluminium Lake."
},
{
"NDCCode": "63304-536-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (63304-536-01)",
"NDC11Code": "63304-0536-01",
"ProductNDC": "63304-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076007",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 12.5",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"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 tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, 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 molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
},
{
"NDCCode": "63304-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (63304-536-05)",
"NDC11Code": "63304-0536-05",
"ProductNDC": "63304-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076007",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 12.5",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"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 tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, 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 molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
},
{
"NDCCode": "0046-1108-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00046-1108-11",
"ProductNDC": "0046-1108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prempro",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020527",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".625; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121203",
"SamplePackage": "N",
"Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
},
{
"NDCCode": "0220-1108-59",
"PackageDescription": "75 g in 1 TUBE (0220-1108-59) ",
"NDC11Code": "00220-1108-59",
"ProductNDC": "0220-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calendula",
"NonProprietaryName": "Calendula Officinalis Flowering Top",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19900413",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2023-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900413",
"SamplePackage": "N",
"IndicationAndUsage": "Helps promote healing of scrapes and skin irritations."
},
{
"NDCCode": "0363-1108-02",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (0363-1108-02)",
"NDC11Code": "00363-1108-02",
"ProductNDC": "0363-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Milk Of Magnesia Mint",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Walgreens",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-31"
},
{
"NDCCode": "10157-1108-1",
"PackageDescription": "1 CYLINDER in 1 BLISTER PACK (10157-1108-1) > 3.69 g in 1 CYLINDER",
"NDC11Code": "10157-1108-01",
"ProductNDC": "10157-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blistex Deep Renewal Broad Spectrum",
"NonProprietaryName": "Dimethicone, Avobenzone, Octinoxate, And Octisalate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Blistex Inc",
"SubstanceName": "DIMETHICONE; AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "2; 3; 6.6; 4.4",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-09-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "22568-1108-1",
"PackageDescription": "20 kg in 1 DRUM (22568-1108-1) ",
"NDC11Code": "22568-1108-01",
"ProductNDC": "22568-1108",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "W. R. Grace & Co.-Conn.",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-06-08",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-JUN-21"
},
{
"NDCCode": "22840-1108-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1108-2) ",
"NDC11Code": "22840-1108-02",
"ProductNDC": "22840-1108",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Dog Epithelia",
"NonProprietaryName": "Canis Lupus Familiaris",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-1108-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1108-4) ",
"NDC11Code": "22840-1108-04",
"ProductNDC": "22840-1108",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Dog Epithelia",
"NonProprietaryName": "Canis Lupus Familiaris",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "33992-1108-1",
"PackageDescription": "396.9 g in 1 BOTTLE, PLASTIC (33992-1108-1)",
"NDC11Code": "33992-1108-01",
"ProductNDC": "33992-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cocoa Butter",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110802",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "GREENBRIER INTERNATIONAL",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Use daily, do not use around eye area."
},
{
"NDCCode": "36987-1108-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1108-1)",
"NDC11Code": "36987-1108-01",
"ProductNDC": "36987-1108",
"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": "20000",
"StrengthUnit": "[PNU]/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": "36987-1108-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1108-2)",
"NDC11Code": "36987-1108-02",
"ProductNDC": "36987-1108",
"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": "20000",
"StrengthUnit": "[PNU]/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": "36987-1108-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1108-3)",
"NDC11Code": "36987-1108-03",
"ProductNDC": "36987-1108",
"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": "20000",
"StrengthUnit": "[PNU]/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": "36987-1108-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1108-4)",
"NDC11Code": "36987-1108-04",
"ProductNDC": "36987-1108",
"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": "20000",
"StrengthUnit": "[PNU]/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": "37662-1108-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1108-1) ",
"NDC11Code": "37662-1108-01",
"ProductNDC": "37662-1108",
"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": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220729",
"SamplePackage": "N"
},
{
"NDCCode": "37662-1108-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1108-2) ",
"NDC11Code": "37662-1108-02",
"ProductNDC": "37662-1108",
"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": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220729",
"SamplePackage": "N"
},
{
"NDCCode": "37662-1108-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-1108-3) ",
"NDC11Code": "37662-1108-03",
"ProductNDC": "37662-1108",
"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": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220729",
"SamplePackage": "N"
},
{
"NDCCode": "39345-1108-1",
"PackageDescription": "20 kg in 1 DRUM (39345-1108-1)",
"NDC11Code": "39345-1108-01",
"ProductNDC": "39345-1108",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20061001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Albemarle Corporation",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "42756-1108-3",
"PackageDescription": "30 g in 1 JAR (42756-1108-3) ",
"NDC11Code": "42756-1108-03",
"ProductNDC": "42756-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nrg Topical Anesthetic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "IQ Dental Supply, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures."
},
{
"NDCCode": "42816-1108-1",
"PackageDescription": "1 BAG in 1 BOX (42816-1108-1) / 69125 TABLET, SUGAR COATED in 1 BAG",
"NDC11Code": "42816-1108-01",
"ProductNDC": "42816-1108",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
"DosageFormName": "TABLET, SUGAR COATED",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Pfizer Ireland Pharmaceuticals Unlimited Company",
"SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": ".625; 5",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-01-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-12"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0536-1108-52</NDCCode>
<PackageDescription>7 PATCH in 1 CARTON (0536-1108-52) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00536-1108-52</NDC11Code>
<ProductNDC>0536-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 1</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1108-71</NDCCode>
<PackageDescription>28 PATCH in 1 CARTON (0536-1108-71) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00536-1108-71</NDC11Code>
<ProductNDC>0536-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 1</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1108-88</NDCCode>
<PackageDescription>14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00536-1108-88</NDC11Code>
<ProductNDC>0536-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 1</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1106-52</NDCCode>
<PackageDescription>7 PATCH in 1 CARTON (0536-1106-52) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00536-1106-52</NDC11Code>
<ProductNDC>0536-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 3</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1107-52</NDCCode>
<PackageDescription>7 PATCH in 1 CARTON (0536-1107-52) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00536-1107-52</NDC11Code>
<ProductNDC>0536-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 2</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51655-536-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, DISPENSING (51655-536-52)</PackageDescription>
<NDC11Code>51655-0536-52</NDC11Code>
<ProductNDC>51655-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt. Metoprolol tartare, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0536-1500-60</NDCCode>
<PackageDescription>160 CAPSULE in 1 BOTTLE (0536-1500-60) </PackageDescription>
<NDC11Code>00536-1500-60</NDC11Code>
<ProductNDC>0536-1500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Reguloid</ProprietaryName>
<NonProprietaryName>Psyllium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100428</StartMarketingDate>
<EndMarketingDate>20191130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>.52</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100428</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-536-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (16714-536-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>16714-0536-01</NDC11Code>
<ProductNDC>16714-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210246</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.</IndicationAndUsage>
<Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid, NF and/or sodium hydroxide, NF.For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: Pyrrolidinium, 3-[(SR)-cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, [RS-] bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33 g/mol. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>16714-536-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (16714-536-25) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>16714-0536-25</NDC11Code>
<ProductNDC>16714-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210246</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.</IndicationAndUsage>
<Description>Glycopyrrolate injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid, NF and/or sodium hydroxide, NF.For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: Pyrrolidinium, 3-[(SR)-cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-, [RS-] bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33 g/mol. Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>53808-0536-1</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (53808-0536-1)</PackageDescription>
<NDC11Code>53808-0536-01</NDC11Code>
<ProductNDC>53808-0536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.</IndicationAndUsage>
<Description>Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG- CoA to mevalonate. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula:. C23 H35 NaO7 MW 446.52. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C Yellow No 10 Aluminium Lake and the 40 mg tablet also contains D&C Yellow No 10 Aluminium Lake and FD&C Blue No. 1-Aluminium Lake.</Description>
</NDC>
<NDC>
<NDCCode>63304-536-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63304-536-01)</PackageDescription>
<NDC11Code>63304-0536-01</NDC11Code>
<ProductNDC>63304-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076007</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 12.5</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<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 tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, 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 molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63304-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (63304-536-05)</PackageDescription>
<NDC11Code>63304-0536-05</NDC11Code>
<ProductNDC>63304-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076007</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 12.5</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<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 tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, 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 molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0046-1108-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00046-1108-11</NDC11Code>
<ProductNDC>0046-1108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prempro</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020527</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.625; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0220-1108-59</NDCCode>
<PackageDescription>75 g in 1 TUBE (0220-1108-59) </PackageDescription>
<NDC11Code>00220-1108-59</NDC11Code>
<ProductNDC>0220-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calendula</ProprietaryName>
<NonProprietaryName>Calendula Officinalis Flowering Top</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19900413</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoires Boiron</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps promote healing of scrapes and skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-1108-02</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (0363-1108-02)</PackageDescription>
<NDC11Code>00363-1108-02</NDC11Code>
<ProductNDC>0363-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Milk Of Magnesia Mint</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>10157-1108-1</NDCCode>
<PackageDescription>1 CYLINDER in 1 BLISTER PACK (10157-1108-1) > 3.69 g in 1 CYLINDER</PackageDescription>
<NDC11Code>10157-1108-01</NDC11Code>
<ProductNDC>10157-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blistex Deep Renewal Broad Spectrum</ProprietaryName>
<NonProprietaryName>Dimethicone, Avobenzone, Octinoxate, And Octisalate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Blistex Inc</LabelerName>
<SubstanceName>DIMETHICONE; AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>2; 3; 6.6; 4.4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>22568-1108-1</NDCCode>
<PackageDescription>20 kg in 1 DRUM (22568-1108-1) </PackageDescription>
<NDC11Code>22568-1108-01</NDC11Code>
<ProductNDC>22568-1108</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Itraconazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>W. R. Grace & Co.-Conn.</LabelerName>
<SubstanceName>ITRACONAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-06-08</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>22840-1108-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1108-2) </PackageDescription>
<NDC11Code>22840-1108-02</NDC11Code>
<ProductNDC>22840-1108</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Dog Epithelia</ProprietaryName>
<NonProprietaryName>Canis Lupus Familiaris</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-1108-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1108-4) </PackageDescription>
<NDC11Code>22840-1108-04</NDC11Code>
<ProductNDC>22840-1108</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Dog Epithelia</ProprietaryName>
<NonProprietaryName>Canis Lupus Familiaris</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>33992-1108-1</NDCCode>
<PackageDescription>396.9 g in 1 BOTTLE, PLASTIC (33992-1108-1)</PackageDescription>
<NDC11Code>33992-1108-01</NDC11Code>
<ProductNDC>33992-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cocoa Butter</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>GREENBRIER INTERNATIONAL</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use daily, do not use around eye area.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1108-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1108-1)</PackageDescription>
<NDC11Code>36987-1108-01</NDC11Code>
<ProductNDC>36987-1108</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>20000</StrengthNumber>
<StrengthUnit>[PNU]/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>36987-1108-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1108-2)</PackageDescription>
<NDC11Code>36987-1108-02</NDC11Code>
<ProductNDC>36987-1108</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>20000</StrengthNumber>
<StrengthUnit>[PNU]/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>36987-1108-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1108-3)</PackageDescription>
<NDC11Code>36987-1108-03</NDC11Code>
<ProductNDC>36987-1108</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>20000</StrengthNumber>
<StrengthUnit>[PNU]/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>36987-1108-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1108-4)</PackageDescription>
<NDC11Code>36987-1108-04</NDC11Code>
<ProductNDC>36987-1108</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>20000</StrengthNumber>
<StrengthUnit>[PNU]/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>37662-1108-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1108-1) </PackageDescription>
<NDC11Code>37662-1108-01</NDC11Code>
<ProductNDC>37662-1108</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>6</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>37662-1108-2</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-1108-2) </PackageDescription>
<NDC11Code>37662-1108-02</NDC11Code>
<ProductNDC>37662-1108</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>6</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>37662-1108-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-1108-3) </PackageDescription>
<NDC11Code>37662-1108-03</NDC11Code>
<ProductNDC>37662-1108</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>6</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>39345-1108-1</NDCCode>
<PackageDescription>20 kg in 1 DRUM (39345-1108-1)</PackageDescription>
<NDC11Code>39345-1108-01</NDC11Code>
<ProductNDC>39345-1108</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Itraconazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20061001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Albemarle Corporation</LabelerName>
<SubstanceName>ITRACONAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42756-1108-3</NDCCode>
<PackageDescription>30 g in 1 JAR (42756-1108-3) </PackageDescription>
<NDC11Code>42756-1108-03</NDC11Code>
<ProductNDC>42756-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nrg Topical Anesthetic</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>IQ Dental Supply, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42816-1108-1</NDCCode>
<PackageDescription>1 BAG in 1 BOX (42816-1108-1) / 69125 TABLET, SUGAR COATED in 1 BAG</PackageDescription>
<NDC11Code>42816-1108-01</NDC11Code>
<ProductNDC>42816-1108</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Conjugated Estrogens And Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Pfizer Ireland Pharmaceuticals Unlimited Company</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>.625; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-12</StartMarketingDatePackage>
</NDC>
</NDCList>