{
"NDC": [
{
"NDCCode": "0065-0795-30",
"PackageDescription": "30 mL in 1 BOTTLE (0065-0795-30) ",
"NDC11Code": "00065-0795-30",
"ProductNDC": "0065-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss",
"NonProprietaryName": "Balanced Salt Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19690328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020742",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE",
"StrengthNumber": "6.4; .75; .48; .3; 3.9; 1.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "19690328",
"EndMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0795-15",
"PackageDescription": "15 mL in 1 BOTTLE (0065-0795-15) ",
"NDC11Code": "00065-0795-15",
"ProductNDC": "0065-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss",
"NonProprietaryName": "Balanced Salt Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19690328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020742",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE",
"StrengthNumber": "6.4; .75; .48; .3; 3.9; 1.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19690328",
"SamplePackage": "N",
"IndicationAndUsage": "For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.",
"Description": "BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg."
},
{
"NDCCode": "0065-0795-25",
"PackageDescription": "250 mL in 1 BOTTLE (0065-0795-25) ",
"NDC11Code": "00065-0795-25",
"ProductNDC": "0065-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss",
"NonProprietaryName": "Balanced Salt Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19690328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020742",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE",
"StrengthNumber": "6.4; .75; .48; .3; 3.9; 1.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "19690328",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0795-50",
"PackageDescription": "500 mL in 1 BOTTLE (0065-0795-50) ",
"NDC11Code": "00065-0795-50",
"ProductNDC": "0065-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bss",
"NonProprietaryName": "Balanced Salt Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19690328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020742",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE",
"StrengthNumber": "6.4; .75; .48; .3; 3.9; 1.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19690328",
"SamplePackage": "N",
"IndicationAndUsage": "For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.",
"Description": "BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg."
},
{
"NDCCode": "0187-0795-30",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) ",
"NDC11Code": "00187-0795-30",
"ProductNDC": "0187-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem Cd",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20010411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020062",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010411",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration."
},
{
"NDCCode": "35356-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (35356-795-30) ",
"NDC11Code": "35356-0795-30",
"ProductNDC": "35356-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201013",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42291-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42291-795-30) ",
"NDC11Code": "42291-0795-30",
"ProductNDC": "42291-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Amlodipine",
"NonProprietaryName": "Telmisartan And Amlodipine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201586",
"LabelerName": "AvKARE",
"SubstanceName": "AMLODIPINE BESYLATE; TELMISARTAN",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N"
},
{
"NDCCode": "43063-795-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30) ",
"NDC11Code": "43063-0795-30",
"ProductNDC": "43063-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091124",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171009",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablet has been shown to decrease sleep latency and improve sleep maintenance ( 1).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, magnesium stearate and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
},
{
"NDCCode": "50090-0795-0",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-0795-0) ",
"NDC11Code": "50090-0795-00",
"ProductNDC": "50090-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076368",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.",
"Description": "The Potassium Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. This formulation is intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. FDA approved dissolution test specifications differ from USP. Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethylcellulose, microcrystalline cellulose."
},
{
"NDCCode": "52427-795-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-795-30) ",
"NDC11Code": "52427-0795-30",
"ProductNDC": "52427-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251006",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219130",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251006",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram Capsules are indicated for the treatment of: : 1 Major depressive disorder (MDD) in adults younger than 65 years of age [see Dosage and Administration (2.1)] and pediatric patients 12 years of age and older., 2 Generalized anxiety disorder (GAD) in adults younger than 65 years of age [see Dosage and Administration (2.1)]. .",
"Description": "Escitalopram Capsules contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.43. Escitalopram oxalate occurs as a fine, white to slightly yellow powder and is freely soluble in methanol and in dimethyl sulphoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol, and insoluble in heptane. Escitalopram Capsules are intended for oral administration and are available only in a 15 mg strength. The capsules contain 15 mg escitalopram (equivalent to 19.16 mg escitalopram oxalate) and the following inactive ingredients: croscarmellose sodium, copovidone, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "53808-0795-1",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (53808-0795-1)",
"NDC11Code": "53808-0795-01",
"ProductNDC": "53808-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zerit",
"NonProprietaryName": "Stavudine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020412",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "STAVUDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ZERIT (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).",
"Description": "ZERIT® is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus (HIV). ZERIT (stavudine) Capsules are supplied for oral administration in strengths of 15, 20, 30, and 40 mg of stavudine. Each capsule also contains inactive ingredients microcrystalline cellulose, sodium starch glycolate, lactose, and magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, and iron oxides. The capsules are printed with edible inks. ZERIT (stavudine) for Oral Solution is supplied as a dye-free, fruit-flavored powder in bottles with child-resistant closures providing 200 mL of a 1 mg/mL stavudine solution upon constitution with water per label instructions. The powder for oral solution contains the following inactive ingredients: methylparaben, propylparaben, sodium carboxymethylcellulose, sucrose, and antifoaming and flavoring agents. The chemical name for stavudine is 2',3'-didehydro-3'-deoxythymidine. Stavudine has the following structural formula:. Stavudine is a white to off-white crystalline solid with the molecular formula C10H12N2O4 and a molecular weight of 224.2. The solubility of stavudine at 23° C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23° C is 0.144."
},
{
"NDCCode": "57520-0795-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (57520-0795-1)",
"NDC11Code": "57520-0795-01",
"ProductNDC": "57520-0795",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caffeic Acid",
"NonProprietaryName": "Caffeic Acid,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110829",
"EndMarketingDate": "20170104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apotheca Company",
"SubstanceName": "CAFFEIC ACID",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "58118-0795-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (58118-0795-3)",
"NDC11Code": "58118-0795-03",
"ProductNDC": "58118-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085223",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "58118-0795-8",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (58118-0795-8) ",
"NDC11Code": "58118-0795-08",
"ProductNDC": "58118-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860730",
"EndMarketingDate": "20200101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085223",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19860730",
"EndMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "60760-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (60760-795-30) ",
"NDC11Code": "60760-0795-30",
"ProductNDC": "60760-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860730",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085223",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19860730",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "63187-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63187-795-30) ",
"NDC11Code": "63187-0795-30",
"ProductNDC": "63187-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride, USP has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "67046-0795-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0795-3) ",
"NDC11Code": "67046-0795-03",
"ProductNDC": "67046-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Coupler LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "70518-0795-0",
"PackageDescription": "30 g in 1 TUBE (70518-0795-0) ",
"NDC11Code": "70518-0795-00",
"ProductNDC": "70518-0795",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anecream",
"NonProprietaryName": "Lidocaine 4%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71205-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71205-795-30) ",
"NDC11Code": "71205-0795-30",
"ProductNDC": "71205-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209302",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230420",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "71335-0795-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0795-3) ",
"NDC11Code": "71335-0795-03",
"ProductNDC": "71335-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180522",
"SamplePackage": "N"
},
{
"NDCCode": "75921-795-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75921-795-30)",
"NDC11Code": "75921-0795-30",
"ProductNDC": "75921-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085223",
"LabelerName": "Life Line Home Care Services, Inc.",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Chemically, it is [Bicyclohexyl]-1-carboxylic acid, 2-(diethyl-amino) ethyl ester, hydrochloride with the following structural formula. C19H35NO2HCI   345.95. Each capsule, for oral administration, contains 10 mg of dicyclomine hydrochloride. Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. This product contains the following inactive ingredients: colloidal silicon dioxide (tablets only), corn starch (tablets only), D&C red #28 (capsules only), FD&C blue #1 (capsules only), FD&C blue #1 lake (tablets only), FD&C red #40 (capsules only), gelatin (capsules only), hypromellose (tablets only), lactose monohydrate (tablets only), magnesium stearate (capsules only), pregelatinized starch, silicon dioxide (capsules only), sodium lauryl sulfate (capsules only), sodium starch glycolate (tablets only), and stearic acid (tablets only)."
},
{
"NDCCode": "0065-0085-38",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-0085-38) > 30 mL in 1 BOTTLE",
"NDC11Code": "00065-0085-38",
"ProductNDC": "0065-0085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naphcon A",
"NonProprietaryName": "Naphazoline Hydrochloride And Pheniramine Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19940608",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020226",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE",
"StrengthNumber": ".25; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19940608",
"EndMarketingDatePackage": "20190228",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0332-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00065-0332-30",
"ProductNDC": "0065-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Patanase",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20080428",
"EndMarketingDate": "20220831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021861",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080428",
"EndMarketingDatePackage": "20220831",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0411-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-0411-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "00065-0411-30",
"ProductNDC": "0065-0411",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betadine",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20000401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018634",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000401",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).",
"Description": "DESCRIPTION: Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows. BETADINE* 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate."
},
{
"NDCCode": "0065-0429-30",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0429-30) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0429-30",
"ProductNDC": "0065-0429",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Systane Lubricant",
"NonProprietaryName": "Polyethylene Glycol 400 And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20030225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": "4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030225",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning and irritation due to dryness of the eye."
},
{
"NDCCode": "0065-0431-33",
"PackageDescription": "30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL",
"NDC11Code": "00065-0431-33",
"ProductNDC": "0065-0431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Systane",
"NonProprietaryName": "Polyethylene Glycol And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20151030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Research Ltd",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": "4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of burning and irritation due to dryness of the eye."
},
{
"NDCCode": "0065-0530-01",
"PackageDescription": "30 mL in 1 BOTTLE (0065-0530-01) ",
"NDC11Code": "00065-0530-01",
"ProductNDC": "0065-0530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Stream",
"NonProprietaryName": "Purified Water",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900930",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "986",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900930",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "0065-1437-04",
"PackageDescription": "30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-04) / .7 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-1437-04",
"ProductNDC": "0065-1437",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Systane Hydration Pf Preservative Free",
"NonProprietaryName": "Polyethylene Glycol 400 And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": "4; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "for use as a protectant against further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "0065-1530-04",
"PackageDescription": "30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1530-04) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00065-1530-04",
"ProductNDC": "0065-1530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Systane Complete Pf",
"NonProprietaryName": "Propylene Glycol",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PROPYLENE GLYCOL",
"StrengthNumber": ".06",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "0065-5040-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-5040-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "00065-5040-30",
"ProductNDC": "0065-5040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tears Naturale Ii Polyquad",
"NonProprietaryName": "Dextran 70, Hypromellose 2910",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0065-0795-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (0065-0795-30) </PackageDescription>
<NDC11Code>00065-0795-30</NDC11Code>
<ProductNDC>0065-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19690328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020742</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE</SubstanceName>
<StrengthNumber>6.4; .75; .48; .3; 3.9; 1.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19690328</StartMarketingDatePackage>
<EndMarketingDatePackage>20181231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-0795-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (0065-0795-15) </PackageDescription>
<NDC11Code>00065-0795-15</NDC11Code>
<ProductNDC>0065-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19690328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020742</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE</SubstanceName>
<StrengthNumber>6.4; .75; .48; .3; 3.9; 1.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19690328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.</IndicationAndUsage>
<Description>BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.</Description>
</NDC>
<NDC>
<NDCCode>0065-0795-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (0065-0795-25) </PackageDescription>
<NDC11Code>00065-0795-25</NDC11Code>
<ProductNDC>0065-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19690328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020742</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE</SubstanceName>
<StrengthNumber>6.4; .75; .48; .3; 3.9; 1.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19690328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-0795-50</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (0065-0795-50) </PackageDescription>
<NDC11Code>00065-0795-50</NDC11Code>
<ProductNDC>0065-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bss</ProprietaryName>
<NonProprietaryName>Balanced Salt Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19690328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020742</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE</SubstanceName>
<StrengthNumber>6.4; .75; .48; .3; 3.9; 1.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19690328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.</IndicationAndUsage>
<Description>BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.</Description>
</NDC>
<NDC>
<NDCCode>0187-0795-30</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) </PackageDescription>
<NDC11Code>00187-0795-30</NDC11Code>
<ProductNDC>0187-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem Cd</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020062</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>35356-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (35356-795-30) </PackageDescription>
<NDC11Code>35356-0795-30</NDC11Code>
<ProductNDC>35356-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201013</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42291-795-30) </PackageDescription>
<NDC11Code>42291-0795-30</NDC11Code>
<ProductNDC>42291-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; TELMISARTAN</SubstanceName>
<StrengthNumber>5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-795-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30) </PackageDescription>
<NDC11Code>43063-0795-30</NDC11Code>
<ProductNDC>43063-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091124</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablet has been shown to decrease sleep latency and improve sleep maintenance ( 1).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, magnesium stearate and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>50090-0795-0</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-0795-0) </PackageDescription>
<NDC11Code>50090-0795-00</NDC11Code>
<ProductNDC>50090-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076368</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.</IndicationAndUsage>
<Description>The Potassium Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. This formulation is intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Potassium Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. FDA approved dissolution test specifications differ from USP. Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethylcellulose, microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>52427-795-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-795-30) </PackageDescription>
<NDC11Code>52427-0795-30</NDC11Code>
<ProductNDC>52427-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251006</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219130</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram Capsules are indicated for the treatment of: : 1 Major depressive disorder (MDD) in adults younger than 65 years of age [see Dosage and Administration (2.1)] and pediatric patients 12 years of age and older., 2 Generalized anxiety disorder (GAD) in adults younger than 65 years of age [see Dosage and Administration (2.1)]. .</IndicationAndUsage>
<Description>Escitalopram Capsules contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.43. Escitalopram oxalate occurs as a fine, white to slightly yellow powder and is freely soluble in methanol and in dimethyl sulphoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol, and insoluble in heptane. Escitalopram Capsules are intended for oral administration and are available only in a 15 mg strength. The capsules contain 15 mg escitalopram (equivalent to 19.16 mg escitalopram oxalate) and the following inactive ingredients: croscarmellose sodium, copovidone, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53808-0795-1</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (53808-0795-1)</PackageDescription>
<NDC11Code>53808-0795-01</NDC11Code>
<ProductNDC>53808-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zerit</ProprietaryName>
<NonProprietaryName>Stavudine</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020412</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>STAVUDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ZERIT (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).</IndicationAndUsage>
<Description>ZERIT® is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus (HIV). ZERIT (stavudine) Capsules are supplied for oral administration in strengths of 15, 20, 30, and 40 mg of stavudine. Each capsule also contains inactive ingredients microcrystalline cellulose, sodium starch glycolate, lactose, and magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, and iron oxides. The capsules are printed with edible inks. ZERIT (stavudine) for Oral Solution is supplied as a dye-free, fruit-flavored powder in bottles with child-resistant closures providing 200 mL of a 1 mg/mL stavudine solution upon constitution with water per label instructions. The powder for oral solution contains the following inactive ingredients: methylparaben, propylparaben, sodium carboxymethylcellulose, sucrose, and antifoaming and flavoring agents. The chemical name for stavudine is 2',3'-didehydro-3'-deoxythymidine. Stavudine has the following structural formula:. Stavudine is a white to off-white crystalline solid with the molecular formula C10H12N2O4 and a molecular weight of 224.2. The solubility of stavudine at 23° C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23° C is 0.144.</Description>
</NDC>
<NDC>
<NDCCode>57520-0795-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (57520-0795-1)</PackageDescription>
<NDC11Code>57520-0795-01</NDC11Code>
<ProductNDC>57520-0795</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Caffeic Acid</ProprietaryName>
<NonProprietaryName>Caffeic Acid,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110829</StartMarketingDate>
<EndMarketingDate>20170104</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apotheca Company</LabelerName>
<SubstanceName>CAFFEIC ACID</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0795-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (58118-0795-3)</PackageDescription>
<NDC11Code>58118-0795-03</NDC11Code>
<ProductNDC>58118-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085223</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0795-8</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0795-8) </PackageDescription>
<NDC11Code>58118-0795-08</NDC11Code>
<ProductNDC>58118-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860730</StartMarketingDate>
<EndMarketingDate>20200101</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085223</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19860730</StartMarketingDatePackage>
<EndMarketingDatePackage>20200101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (60760-795-30) </PackageDescription>
<NDC11Code>60760-0795-30</NDC11Code>
<ProductNDC>60760-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860730</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085223</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19860730</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63187-795-30) </PackageDescription>
<NDC11Code>63187-0795-30</NDC11Code>
<ProductNDC>63187-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride, USP has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>67046-0795-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0795-3) </PackageDescription>
<NDC11Code>67046-0795-03</NDC11Code>
<ProductNDC>67046-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-0795-0</NDCCode>
<PackageDescription>30 g in 1 TUBE (70518-0795-0) </PackageDescription>
<NDC11Code>70518-0795-00</NDC11Code>
<ProductNDC>70518-0795</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anecream</ProprietaryName>
<NonProprietaryName>Lidocaine 4%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71205-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71205-795-30) </PackageDescription>
<NDC11Code>71205-0795-30</NDC11Code>
<ProductNDC>71205-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209302</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71335-0795-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-0795-3) </PackageDescription>
<NDC11Code>71335-0795-03</NDC11Code>
<ProductNDC>71335-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203584</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75921-795-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75921-795-30)</PackageDescription>
<NDC11Code>75921-0795-30</NDC11Code>
<ProductNDC>75921-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085223</ApplicationNumber>
<LabelerName>Life Line Home Care Services, Inc.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Chemically, it is [Bicyclohexyl]-1-carboxylic acid, 2-(diethyl-amino) ethyl ester, hydrochloride with the following structural formula. C19H35NO2HCI   345.95. Each capsule, for oral administration, contains 10 mg of dicyclomine hydrochloride. Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. This product contains the following inactive ingredients: colloidal silicon dioxide (tablets only), corn starch (tablets only), D&C red #28 (capsules only), FD&C blue #1 (capsules only), FD&C blue #1 lake (tablets only), FD&C red #40 (capsules only), gelatin (capsules only), hypromellose (tablets only), lactose monohydrate (tablets only), magnesium stearate (capsules only), pregelatinized starch, silicon dioxide (capsules only), sodium lauryl sulfate (capsules only), sodium starch glycolate (tablets only), and stearic acid (tablets only).</Description>
</NDC>
<NDC>
<NDCCode>0065-0085-38</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-0085-38) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-0085-38</NDC11Code>
<ProductNDC>0065-0085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naphcon A</ProprietaryName>
<NonProprietaryName>Naphazoline Hydrochloride And Pheniramine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19940608</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020226</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>.25; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940608</StartMarketingDatePackage>
<EndMarketingDatePackage>20190228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-0332-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-0332-30</NDC11Code>
<ProductNDC>0065-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Patanase</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20080428</StartMarketingDate>
<EndMarketingDate>20220831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021861</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080428</StartMarketingDatePackage>
<EndMarketingDatePackage>20220831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-0411-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-0411-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-0411-30</NDC11Code>
<ProductNDC>0065-0411</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betadine</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20000401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018634</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).</IndicationAndUsage>
<Description>DESCRIPTION: Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows. BETADINE* 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>0065-0429-30</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0429-30) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0429-30</NDC11Code>
<ProductNDC>0065-0429</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Systane Lubricant</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400 And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20030225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-0431-33</NDCCode>
<PackageDescription>30 VIAL in 1 CARTON (0065-0431-33) / .7 mL in 1 VIAL</PackageDescription>
<NDC11Code>00065-0431-33</NDC11Code>
<ProductNDC>0065-0431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Systane</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Research Ltd</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-0530-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (0065-0530-01) </PackageDescription>
<NDC11Code>00065-0530-01</NDC11Code>
<ProductNDC>0065-0530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Stream</ProprietaryName>
<NonProprietaryName>Purified Water</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>986</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-1437-04</NDCCode>
<PackageDescription>30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1437-04) / .7 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00065-1437-04</NDC11Code>
<ProductNDC>0065-1437</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Systane Hydration Pf Preservative Free</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400 And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>4; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for use as a protectant against further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-1530-04</NDCCode>
<PackageDescription>30 VIAL, SINGLE-DOSE in 1 CARTON (0065-1530-04) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00065-1530-04</NDC11Code>
<ProductNDC>0065-1530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Systane Complete Pf</ProprietaryName>
<NonProprietaryName>Propylene Glycol</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0065-5040-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-5040-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-5040-30</NDC11Code>
<ProductNDC>0065-5040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tears Naturale Ii Polyquad</ProprietaryName>
<NonProprietaryName>Dextran 70, Hypromellose 2910</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70</SubstanceName>
<StrengthNumber>3; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>