{
"NDC": [
{
"NDCCode": "59651-088-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18) ",
"NDC11Code": "59651-0088-18",
"ProductNDC": "59651-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Hydrochloride",
"NonProprietaryName": "Sevelamer Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212599",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230711",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.",
"Description": "The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is white to off-white hygroscopic powder, practically insoluble in water and in methanol. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are acetylated monoglyceride, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, shellac glaze and talc."
},
{
"NDCCode": "64330-088-17",
"PackageDescription": "18 kg in 1 DRUM (64330-088-17)",
"NDC11Code": "64330-0088-17",
"ProductNDC": "64330-088",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Temazepam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Centaur Pharmaceuticals Private Limited",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "59651-009-18",
"PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) ",
"NDC11Code": "59651-0009-18",
"ProductNDC": "59651-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209081",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221223",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red."
},
{
"NDCCode": "59651-010-18",
"PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-010-18) ",
"NDC11Code": "59651-0010-18",
"ProductNDC": "59651-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209081",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221223",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red."
},
{
"NDCCode": "59651-018-18",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-18) ",
"NDC11Code": "59651-0018-18",
"ProductNDC": "59651-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niacin",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209236",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NIACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC], Nicotinic Acids [CS]",
"Status": "Active",
"LastUpdate": "2023-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].",
"Description": "Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "59651-019-18",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18) ",
"NDC11Code": "59651-0019-18",
"ProductNDC": "59651-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niacin",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209236",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NIACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC], Nicotinic Acids [CS]",
"Status": "Active",
"LastUpdate": "2023-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].",
"Description": "Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "59651-020-18",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-020-18) ",
"NDC11Code": "59651-0020-18",
"ProductNDC": "59651-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niacin",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209236",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC], Nicotinic Acids [CS]",
"Status": "Active",
"LastUpdate": "2023-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].",
"Description": "Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending."
},
{
"NDCCode": "59651-314-18",
"PackageDescription": "1800 CAPSULE in 1 BAG (59651-314-18) ",
"NDC11Code": "59651-0314-18",
"ProductNDC": "59651-314",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20200324",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-03-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "24-MAR-20"
},
{
"NDCCode": "59651-392-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (59651-392-18) ",
"NDC11Code": "59651-0392-18",
"ProductNDC": "59651-392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078246",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline powder, very soluble in water, freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate, practically insoluble in hexane with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablet also contains ferric oxide."
},
{
"NDCCode": "59651-439-18",
"PackageDescription": "18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR",
"NDC11Code": "59651-0439-18",
"ProductNDC": "59651-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Vaginal Inserts",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "VAGINAL",
"StartMarketingDate": "20240802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216550",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESTRADIOL HEMIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240802",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause (1.1).",
"Description": "Estradiol vaginal inserts USP, 10 mcg are round, white to off-white, film-coated tablets debossed with “S” on one side and “10” on other side containing 10.3 mcg of estradiol hemihydrate USP equivalent to 10 mcg of estradiol USP. Each insert of estradiol vaginal inserts USP, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. Each estradiol vaginal inserts, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol hemihydrate is a white or creamy white, small crystals or crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 ½ H2O with a molecular weight of 281.4. The structural formula is: FDA approved IVR method and acceptance criteria differs from the USP IVR method and acceptance criteria."
},
{
"NDCCode": "59651-849-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) ",
"NDC11Code": "59651-0849-18",
"ProductNDC": "59651-849",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208544",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250410",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) .",
"Description": "Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is a white to yellowish powder. Rivaroxaban, USP is slightly soluble in dimethyl sulfoxide, practically insoluble in acetone and in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "41163-088-10",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (41163-088-10) ",
"NDC11Code": "41163-0088-10",
"ProductNDC": "41163-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iodine",
"NonProprietaryName": "Iodine",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "IODINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050204",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "41366-088-01",
"PackageDescription": "45 mL in 1 BOTTLE (41366-088-01) ",
"NDC11Code": "41366-0088-01",
"ProductNDC": "41366-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Black Cherry Fig Hand Sanitizer",
"NonProprietaryName": "Black Cherry Fig Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20250610",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Zhejiang Meimi Technology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that may cause disease."
},
{
"NDCCode": "42708-088-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-088-14) ",
"NDC11Code": "42708-0088-14",
"ProductNDC": "42708-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "QPharma Inc",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190111",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "Y",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: : 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "49967-088-01",
"PackageDescription": "1 TUBE in 1 CARTON (49967-088-01) > 150 mL in 1 TUBE",
"NDC11Code": "49967-0088-01",
"ProductNDC": "49967-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vichy Laboratoire",
"ProprietaryNameSuffix": "Capital Soleil Spf 60 Soft Sheer Sunscreen",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110421",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "4.5; 22.5; 7.5; 7.5; 9",
"StrengthUnit": "mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "56062-088-02",
"PackageDescription": "25 BLISTER PACK in 1 CARTON (56062-088-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "56062-0088-02",
"ProductNDC": "56062-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077351",
"LabelerName": "Publix Super Markets Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260306",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "60687-486-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-486-01) / 1 TABLET in 1 BLISTER PACK (60687-486-11) ",
"NDC11Code": "60687-0486-01",
"ProductNDC": "60687-486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209713",
"LabelerName": "American Health Packaging",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".088",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191028",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5' tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4xH 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablets USP contains the inactive ingredients corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablet USP meets USP Dissolution Test 2."
},
{
"NDCCode": "61919-088-02",
"PackageDescription": "2 TABLET in 1 BOTTLE (61919-088-02) ",
"NDC11Code": "61919-0088-02",
"ProductNDC": "61919-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071135",
"LabelerName": "Direct_Rx",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190710",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system. Pharmacokinetics. Absorption. After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 – 1.5 hours with a range of 0.25 to 2.5 hours. Absorption is delayed and decreased when administered with a moderate fat meal. In the presence of food mean lag times are approximately 45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours when fasting. This results in an average decrease in Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food. Distribution. Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam and its metabolites cross the blood-brain and placental barriers and are also found in breast milk in concentrations approximately one tenth of those in maternal plasma (days 3 to 9 post-partum). In young healthy males, the volume of distribution at steady-state is 0.8 to 1.0 L/kg. The decline in the plasma concentration-time profile after oral administration is biphasic. The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. Metabolism. Diazepam is N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyldiazepam and temazepam are both further metabolized to oxazepam. Temazepam and oxazepam are largely eliminated by glucuronidation. Elimination. The initial distribution phase is followed by a prolonged terminal elimination phase (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide conjugates. The clearance of diazepam is 20 to 30 mL/min in young adults. Diazepam accumulates upon multiple dosing and there is some evidence that the terminal elimination half-life is slightly prolonged. Pharmacokinetics in Special Populations. Children. In children 3 - 8 years old the mean half-life of diazepam has been reported to be 18 hours. Newborns. In full term infants, elimination half-lives around 30 hours have been reported, with a longer average half-life of 54 hours reported in premature infants of 28 - 34 weeks gestational age and 8 - 81 days post-partum. In both premature and full term infants the active metabolite desmethyldiazepam shows evidence of continued accumulation compared to children. Longer half-lives in infants may be due to incomplete maturation of metabolic pathways. Geriatric. Elimination half-life increases by approximately 1 hour for each year of age beginning with a half-life of 20 hours at 20 years of age. This appears to be due to an increase in volume of distribution with age and a decrease in clearance. Consequently, the elderly may have lower peak concentrations, and on multiple dosing higher trough concentrations. It will also take longer to reach steady-state. Conflicting information has been published on changes of plasma protein binding in the elderly. Reported changes in free drug may be due to significant decreases in plasma proteins due to causes other than simply aging. Hepatic Insufficiency. In mild and moderate cirrhosis, average half-life is increased. The average increase has been variously reported from 2-fold to 5-fold, with individual half-lives over 500 hours reported. There is also an increase in volume of distribution, and average clearance decreases by almost half. Mean half-life is also prolonged with hepatic fibrosis to 90 hours (range 66 - 104 hours), with chronic active hepatitis to 60 hours (range 26 - 76 hours), and with acute viral hepatitis to 74 hours (range 49 - 129). In chronic active hepatitis, clearance is decreased by almost half.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. [Chemical Structure]. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
},
{
"NDCCode": "63323-088-61",
"PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "63323-0088-61",
"ProductNDC": "63323-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010112",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "234",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010112",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
"Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated). Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion."
},
{
"NDCCode": "63323-088-63",
"PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63) / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "63323-0088-63",
"ProductNDC": "63323-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010112",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "234",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010112",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.",
"Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated). Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion."
},
{
"NDCCode": "65219-656-10",
"PackageDescription": "24 POUCH in 1 CARTON (65219-656-10) / 1 BAG in 1 POUCH (65219-656-01) / 100 mL in 1 BAG",
"NDC11Code": "65219-0656-10",
"ProductNDC": "65219-656",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250615",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212832",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "11.2; 11.8",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250615",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.",
"Description": "Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container."
},
{
"NDCCode": "65219-658-25",
"PackageDescription": "30 POUCH in 1 CARTON (65219-658-25) / 1 BAG in 1 POUCH (65219-658-01) / 250 mL in 1 BAG",
"NDC11Code": "65219-0658-25",
"ProductNDC": "65219-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250615",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212832",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "4.48; 4.72",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250615",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.",
"Description": "Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container."
},
{
"NDCCode": "68025-088-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-30) ",
"NDC11Code": "68025-0088-30",
"ProductNDC": "68025-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relexxii",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216117",
"LabelerName": "Vertical Pharmaceuticals, LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220623",
"SamplePackage": "N",
"IndicationAndUsage": "RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized."
},
{
"NDCCode": "70121-1722-9",
"PackageDescription": "24 POUCH in 1 CARTON (70121-1722-9) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "70121-1722-09",
"ProductNDC": "70121-1722",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates In Sodium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240730",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218343",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "4.48; 4.72",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240730",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.",
"Description": "Potassium Phosphates in 0.9% Sodium Chloride Injection, for intravenous use, is a phosphorus replacement product containing phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL. It is a sterile, non-pyrogenic, ready-to-use diluted solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in 0.9% sodium chloride. No dilution is required before administration. It is supplied in 250 mL single-dose intravenous infusion bag. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 4.48 mg of monobasic potassium phosphate, USP and 4.72 mg of dibasic potassium phosphate, USP. Each mL contains phosphorus, 0.06 mmol (equivalent to 1.86 mg phosphorus); potassium, 0.088 mEq (equivalent to 3.40 mg of potassium); sodium chloride, USP, 9 mg and water for injection, USP (q.s.). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. This product contains no more than 25 mcg/L of aluminum. The pH is 5.8 to 7.2 and the osmolarity is 0.455 mOsmol/mL (calc)."
},
{
"NDCCode": "73928-088-01",
"PackageDescription": "35 mL in 1 BOTTLE (73928-088-01) ",
"NDC11Code": "73928-0088-01",
"ProductNDC": "73928-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sherk Sanitizer Green Apple",
"NonProprietaryName": "Alcohol Antiseptic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Kingkey MBC Life Technology Group Co.,Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "59651-004-37",
"PackageDescription": "1 kg in 1 BOTTLE, GLASS (59651-004-37) ",
"NDC11Code": "59651-0004-37",
"ProductNDC": "59651-004",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150918",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OCTREOTIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-07",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "18-SEP-15"
},
{
"NDCCode": "59651-027-22",
"PackageDescription": "2000 CAPSULE in 1 BAG (59651-027-22) ",
"NDC11Code": "59651-0027-22",
"ProductNDC": "59651-027",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-04-07",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20-JUL-18"
},
{
"NDCCode": "59651-028-22",
"PackageDescription": "2000 CAPSULE in 1 BAG (59651-028-22) ",
"NDC11Code": "59651-0028-22",
"ProductNDC": "59651-028",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-04-07",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20-JUL-18"
},
{
"NDCCode": "59651-034-39",
"PackageDescription": "35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) ",
"NDC11Code": "59651-0034-39",
"ProductNDC": "59651-034",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-12-29",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "18-NOV-22"
},
{
"NDCCode": "59651-035-71",
"PackageDescription": "7000 TABLET in 1 BAG (59651-035-71) ",
"NDC11Code": "59651-0035-71",
"ProductNDC": "59651-035",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"StartMarketingDate": "20180416",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-11-08",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "16-APR-18"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59651-088-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18) </PackageDescription>
<NDC11Code>59651-0088-18</NDC11Code>
<ProductNDC>59651-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Hydrochloride</ProprietaryName>
<NonProprietaryName>Sevelamer Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212599</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.</IndicationAndUsage>
<Description>The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is white to off-white hygroscopic powder, practically insoluble in water and in methanol. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 800 mg or 400 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are acetylated monoglyceride, ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, shellac glaze and talc.</Description>
</NDC>
<NDC>
<NDCCode>64330-088-17</NDCCode>
<PackageDescription>18 kg in 1 DRUM (64330-088-17)</PackageDescription>
<NDC11Code>64330-0088-17</NDC11Code>
<ProductNDC>64330-088</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59651-009-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) </PackageDescription>
<NDC11Code>59651-0009-18</NDC11Code>
<ProductNDC>59651-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209081</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59651-010-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-010-18) </PackageDescription>
<NDC11Code>59651-0010-18</NDC11Code>
<ProductNDC>59651-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209081</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59651-018-18</NDCCode>
<PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-18) </PackageDescription>
<NDC11Code>59651-0018-18</NDC11Code>
<ProductNDC>59651-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niacin</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209236</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC], Nicotinic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>59651-019-18</NDCCode>
<PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18) </PackageDescription>
<NDC11Code>59651-0019-18</NDC11Code>
<ProductNDC>59651-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niacin</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209236</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC], Nicotinic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>59651-020-18</NDCCode>
<PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-020-18) </PackageDescription>
<NDC11Code>59651-0020-18</NDC11Code>
<ProductNDC>59651-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niacin</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209236</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC], Nicotinic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Niacin extended-release tablets USP, contain niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin USP (nicotinic acid, or 3-pyridinecarboxylic acid) is white crystals or crystalline powder, sparingly soluble in water, soluble in boiling alcohol, freely soluble in boiling water and in solutions of alkali hydroxides and carbonates. Very slightly soluble in ether, with the following structural formula: Niacin extended-release tablets USP are white to off-white, film-coated tablets for oral administration and are available in three tablet strengths containing 500 mg, 750 mg, and 1,000 mg niacin, USP. Niacin extended-release tablets USP also contain the inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>59651-314-18</NDCCode>
<PackageDescription>1800 CAPSULE in 1 BAG (59651-314-18) </PackageDescription>
<NDC11Code>59651-0314-18</NDC11Code>
<ProductNDC>59651-314</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20200324</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-03-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-MAR-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-392-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (59651-392-18) </PackageDescription>
<NDC11Code>59651-0392-18</NDC11Code>
<ProductNDC>59651-392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078246</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline powder, very soluble in water, freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate, practically insoluble in hexane with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablet also contains ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>59651-439-18</NDCCode>
<PackageDescription>18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR</PackageDescription>
<NDC11Code>59651-0439-18</NDC11Code>
<ProductNDC>59651-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Vaginal Inserts</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20240802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216550</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ESTRADIOL HEMIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause (1.1).</IndicationAndUsage>
<Description>Estradiol vaginal inserts USP, 10 mcg are round, white to off-white, film-coated tablets debossed with “S” on one side and “10” on other side containing 10.3 mcg of estradiol hemihydrate USP equivalent to 10 mcg of estradiol USP. Each insert of estradiol vaginal inserts USP, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. Each estradiol vaginal inserts, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol hemihydrate is a white or creamy white, small crystals or crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 ½ H2O with a molecular weight of 281.4. The structural formula is: FDA approved IVR method and acceptance criteria differs from the USP IVR method and acceptance criteria.</Description>
</NDC>
<NDC>
<NDCCode>59651-849-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) </PackageDescription>
<NDC11Code>59651-0849-18</NDC11Code>
<ProductNDC>59651-849</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208544</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) .</IndicationAndUsage>
<Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is a white to yellowish powder. Rivaroxaban, USP is slightly soluble in dimethyl sulfoxide, practically insoluble in acetone and in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>41163-088-10</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (41163-088-10) </PackageDescription>
<NDC11Code>41163-0088-10</NDC11Code>
<ProductNDC>41163-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iodine</ProprietaryName>
<NonProprietaryName>Iodine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>IODINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent skin infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41366-088-01</NDCCode>
<PackageDescription>45 mL in 1 BOTTLE (41366-088-01) </PackageDescription>
<NDC11Code>41366-0088-01</NDC11Code>
<ProductNDC>41366-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Black Cherry Fig Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Black Cherry Fig Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20250610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Zhejiang Meimi Technology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that may cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42708-088-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-088-14) </PackageDescription>
<NDC11Code>42708-0088-14</NDC11Code>
<ProductNDC>42708-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>QPharma Inc</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190111</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: : 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49967-088-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49967-088-01) > 150 mL in 1 TUBE</PackageDescription>
<NDC11Code>49967-0088-01</NDC11Code>
<ProductNDC>49967-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vichy Laboratoire</ProprietaryName>
<ProprietaryNameSuffix>Capital Soleil Spf 60 Soft Sheer Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110421</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>4.5; 22.5; 7.5; 7.5; 9</StrengthNumber>
<StrengthUnit>mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>56062-088-02</NDCCode>
<PackageDescription>25 BLISTER PACK in 1 CARTON (56062-088-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>56062-0088-02</NDC11Code>
<ProductNDC>56062-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Reducer</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077351</ApplicationNumber>
<LabelerName>Publix Super Markets Inc</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60687-486-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-486-01) / 1 TABLET in 1 BLISTER PACK (60687-486-11) </PackageDescription>
<NDC11Code>60687-0486-01</NDC11Code>
<ProductNDC>60687-486</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209713</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.088</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5' tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4xH 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablets USP contains the inactive ingredients corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablet USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>61919-088-02</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (61919-088-02) </PackageDescription>
<NDC11Code>61919-0088-02</NDC11Code>
<ProductNDC>61919-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071135</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system. Pharmacokinetics. Absorption. After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 – 1.5 hours with a range of 0.25 to 2.5 hours. Absorption is delayed and decreased when administered with a moderate fat meal. In the presence of food mean lag times are approximately 45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours when fasting. This results in an average decrease in Cmax of 20% in addition to a 27% decrease in AUC (range 15% to 50%) when administered with food. Distribution. Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam and its metabolites cross the blood-brain and placental barriers and are also found in breast milk in concentrations approximately one tenth of those in maternal plasma (days 3 to 9 post-partum). In young healthy males, the volume of distribution at steady-state is 0.8 to 1.0 L/kg. The decline in the plasma concentration-time profile after oral administration is biphasic. The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. Metabolism. Diazepam is N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyldiazepam and temazepam are both further metabolized to oxazepam. Temazepam and oxazepam are largely eliminated by glucuronidation. Elimination. The initial distribution phase is followed by a prolonged terminal elimination phase (half-life up to 48 hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide conjugates. The clearance of diazepam is 20 to 30 mL/min in young adults. Diazepam accumulates upon multiple dosing and there is some evidence that the terminal elimination half-life is slightly prolonged. Pharmacokinetics in Special Populations. Children. In children 3 - 8 years old the mean half-life of diazepam has been reported to be 18 hours. Newborns. In full term infants, elimination half-lives around 30 hours have been reported, with a longer average half-life of 54 hours reported in premature infants of 28 - 34 weeks gestational age and 8 - 81 days post-partum. In both premature and full term infants the active metabolite desmethyldiazepam shows evidence of continued accumulation compared to children. Longer half-lives in infants may be due to incomplete maturation of metabolic pathways. Geriatric. Elimination half-life increases by approximately 1 hour for each year of age beginning with a half-life of 20 hours at 20 years of age. This appears to be due to an increase in volume of distribution with age and a decrease in clearance. Consequently, the elderly may have lower peak concentrations, and on multiple dosing higher trough concentrations. It will also take longer to reach steady-state. Conflicting information has been published on changes of plasma protein binding in the elderly. Reported changes in free drug may be due to significant decreases in plasma proteins due to causes other than simply aging. Hepatic Insufficiency. In mild and moderate cirrhosis, average half-life is increased. The average increase has been variously reported from 2-fold to 5-fold, with individual half-lives over 500 hours reported. There is also an increase in volume of distribution, and average clearance decreases by almost half. Mean half-life is also prolonged with hepatic fibrosis to 90 hours (range 66 - 104 hours), with chronic active hepatitis to 60 hours (range 26 - 76 hours), and with acute viral hepatitis to 74 hours (range 49 - 129). In chronic active hepatitis, clearance is decreased by almost half.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. [Chemical Structure]. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>63323-088-61</NDCCode>
<PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>63323-0088-61</NDC11Code>
<ProductNDC>63323-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010112</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>234</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated). Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.</Description>
</NDC>
<NDC>
<NDCCode>63323-088-63</NDCCode>
<PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63) / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>63323-0088-63</NDC11Code>
<ProductNDC>63323-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010112</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>234</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparation contains 4 mEq/mL (23.4%) sodium chloride, in Water for Injection. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH of the solution ranges from 4.5 to 7.0. Each mL contains: Sodium chloride 234 mg; Water for Injection q.s. pH may have been adjusted with hydrochloric acid. The osmolar concentration of the 4 mEq/mL solution is 8 mOsmol/mL (calculated). Sodium chloride is chemically designated NaCI, a white crystalline compound freely soluble in water. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion.</Description>
</NDC>
<NDC>
<NDCCode>65219-656-10</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (65219-656-10) / 1 BAG in 1 POUCH (65219-656-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>65219-0656-10</NDC11Code>
<ProductNDC>65219-656</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250615</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212832</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>11.2; 11.8</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container.</Description>
</NDC>
<NDC>
<NDCCode>65219-658-25</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (65219-658-25) / 1 BAG in 1 POUCH (65219-658-01) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>65219-0658-25</NDC11Code>
<ProductNDC>65219-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250615</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212832</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>4.48; 4.72</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container.</Description>
</NDC>
<NDC>
<NDCCode>68025-088-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-088-30) </PackageDescription>
<NDC11Code>68025-0088-30</NDC11Code>
<ProductNDC>68025-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relexxii</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216117</ApplicationNumber>
<LabelerName>Vertical Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.</Description>
</NDC>
<NDC>
<NDCCode>70121-1722-9</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (70121-1722-9) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>70121-1722-09</NDC11Code>
<ProductNDC>70121-1722</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates In Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240730</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218343</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>4.48; 4.72</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates in 0.9% Sodium Chloride Injection, for intravenous use, is a phosphorus replacement product containing phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL. It is a sterile, non-pyrogenic, ready-to-use diluted solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in 0.9% sodium chloride. No dilution is required before administration. It is supplied in 250 mL single-dose intravenous infusion bag. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 4.48 mg of monobasic potassium phosphate, USP and 4.72 mg of dibasic potassium phosphate, USP. Each mL contains phosphorus, 0.06 mmol (equivalent to 1.86 mg phosphorus); potassium, 0.088 mEq (equivalent to 3.40 mg of potassium); sodium chloride, USP, 9 mg and water for injection, USP (q.s.). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. This product contains no more than 25 mcg/L of aluminum. The pH is 5.8 to 7.2 and the osmolarity is 0.455 mOsmol/mL (calc).</Description>
</NDC>
<NDC>
<NDCCode>73928-088-01</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE (73928-088-01) </PackageDescription>
<NDC11Code>73928-0088-01</NDC11Code>
<ProductNDC>73928-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sherk Sanitizer Green Apple</ProprietaryName>
<NonProprietaryName>Alcohol Antiseptic</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Kingkey MBC Life Technology Group Co.,Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-004-37</NDCCode>
<PackageDescription>1 kg in 1 BOTTLE, GLASS (59651-004-37) </PackageDescription>
<NDC11Code>59651-0004-37</NDC11Code>
<ProductNDC>59651-004</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150918</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-07</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-SEP-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-027-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BAG (59651-027-22) </PackageDescription>
<NDC11Code>59651-0027-22</NDC11Code>
<ProductNDC>59651-027</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-04-07</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JUL-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-028-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BAG (59651-028-22) </PackageDescription>
<NDC11Code>59651-0028-22</NDC11Code>
<ProductNDC>59651-028</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-04-07</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JUL-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-034-39</NDCCode>
<PackageDescription>35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) </PackageDescription>
<NDC11Code>59651-0034-39</NDC11Code>
<ProductNDC>59651-034</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-29</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-035-71</NDCCode>
<PackageDescription>7000 TABLET in 1 BAG (59651-035-71) </PackageDescription>
<NDC11Code>59651-0035-71</NDC11Code>
<ProductNDC>59651-035</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20180416</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-08</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-APR-18</StartMarketingDatePackage>
</NDC>
</NDCList>