RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (35 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "61314-238-05",
      "PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (61314-238-05) ",
      "NDC11Code": "61314-0238-05",
      "ProductNDC": "61314-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carteolol Hydrochloride",
      "NonProprietaryName": "Carteolol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20000105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075476",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CARTEOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.",
      "Description": "Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water."
    },
    {
      "NDCCode": "61314-238-10",
      "PackageDescription": "10 mL in 1 BOTTLE, PLASTIC (61314-238-10) ",
      "NDC11Code": "61314-0238-10",
      "ProductNDC": "61314-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carteolol Hydrochloride",
      "NonProprietaryName": "Carteolol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20000105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075476",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CARTEOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.",
      "Description": "Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water."
    },
    {
      "NDCCode": "61314-238-15",
      "PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (61314-238-15) ",
      "NDC11Code": "61314-0238-15",
      "ProductNDC": "61314-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carteolol Hydrochloride",
      "NonProprietaryName": "Carteolol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20000105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075476",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "CARTEOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-02-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.",
      "Description": "Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water."
    },
    {
      "NDCCode": "42571-238-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42571-238-05) ",
      "NDC11Code": "42571-0238-05",
      "ProductNDC": "42571-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
      "NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207435",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) < 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) < 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) < 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) < 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil  tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil  tablets 10/40 mg.",
      "Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablets is chemically described as 3-ethyl-5­ methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablets is chemically described as 2,3­ dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1H-tetrazol-5­-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is:. Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Olmesartan medoxomil is sparingly soluble in methanol and practically insoluble in water. Tablet Strength 5/20 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol and talc (opadry II white). Tablet Strength 5/40 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc and iron oxide yellow (opadry II yellow). Tablet Strength 10/20 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow and iron oxide red (opadry II beige). Tablet Strength 10/40 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow, iron oxide red and ferrosoferric oxide/ iron oxide black (opadry II brown)."
    },
    {
      "NDCCode": "45861-083-05",
      "PackageDescription": "238 d in 1 BOTTLE (45861-083-05) ",
      "NDC11Code": "45861-0083-05",
      "ProductNDC": "45861-083",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
      "NonProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090812",
      "LabelerName": "Pharmaceutica North America, Inc.",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350",
      "StrengthNumber": "17",
      "StrengthUnit": "g/d",
      "Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-03-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250210",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
    },
    {
      "NDCCode": "51407-238-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (51407-238-05) ",
      "NDC11Code": "51407-0238-05",
      "ProductNDC": "51407-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19851119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070213",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
      "Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
    },
    {
      "NDCCode": "52584-238-05",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (52584-238-05)  > 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "52584-0238-05",
      "ProductNDC": "52584-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone Sodium Phosphate",
      "NonProprietaryName": "Dexamethasone Sodium Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
      "StartMarketingDate": "20190906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206781",
      "LabelerName": "General Injectables & Vaccines, Inc.",
      "SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190906",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55150-238-05",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (55150-238-05)  / 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "55150-0238-05",
      "ProductNDC": "55150-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone Sodium Phosphate",
      "NonProprietaryName": "Dexamethasone Sodium Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
      "StartMarketingDate": "20151201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206781",
      "LabelerName": "Eugia US LLC",
      "SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151201",
      "SamplePackage": "N",
      "IndicationAndUsage": "A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.   Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3.     Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus.Acute rheumatic carditis. 4.    Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5.     Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6.    Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7.   Gastrointestinal diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8.   Respiratory diseases. Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9.  Hematologic disorders:. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. B. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).",
      "Description": "Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula: Dexamethasone sodium phosphate injection USP is available in 4 mg/mL concentration. Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL, contains 4.37 mg of dexamethasone sodium phosphate, USP equivalent to 4 mg dexamethasone phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide. ACTIONS — Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli."
    },
    {
      "NDCCode": "57237-238-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (57237-238-05)",
      "NDC11Code": "57237-0238-05",
      "ProductNDC": "57237-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203494",
      "LabelerName": "Citron Pharma LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-06",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "66083-741-05",
      "PackageDescription": "238 L in 1 DEWAR (66083-741-05)",
      "NDC11Code": "66083-0741-05",
      "ProductNDC": "66083-741",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19360101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Boone Drugs, Inc",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-03",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "68382-238-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (68382-238-05) ",
      "NDC11Code": "68382-0238-05",
      "ProductNDC": "68382-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziprasidone",
      "NonProprietaryName": "Ziprasidone",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208988",
      "LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
      "SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20171228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-238-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-238-05) ",
      "NDC11Code": "68428-0238-05",
      "ProductNDC": "68428-238",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aurum Bromatum",
      "NonProprietaryName": "Gold Tribromide",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100203",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "GOLD TRIBROMIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68998-238-05",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (68998-238-05)  / 12 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "68998-0238-05",
      "ProductNDC": "68998-238",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold Max",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221005",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MARC GLASSMAN, INC.",
      "SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 10; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221005",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatnasal congestioncoughsinus congestion and pressure. helps clear nasal passages. promotes nasal and sinus drainage. temporarily reduces fever."
    },
    {
      "NDCCode": "70412-238-05",
      "PackageDescription": "5 mL in 1 TUBE (70412-238-05) ",
      "NDC11Code": "70412-0238-05",
      "ProductNDC": "70412-238",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Spf30 Sunscreen",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Ocitsalate",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Zhejiang Ayan Biotech Co., Ltd.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE",
      "StrengthNumber": "30; 100; 100; 50",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2023-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "70412-817-05",
      "PackageDescription": "1 KIT in 1 KIT (70412-817-05)  *  1 BOTTLE in 1 BOX (70412-119-05)  / 5 mL in 1 BOTTLE *  5 mL in 1 TUBE (70412-238-05) ",
      "NDC11Code": "70412-0817-05",
      "ProductNDC": "70412-817",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Spf30 Sunscreen And Antibacterial Hand Sanitizer",
      "NonProprietaryName": "Alcohol, Avobenzone, Homosalate, Octocrylene, Octisalate",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Zhejiang Ayan Biotech Co., Ltd.",
      "Status": "Active",
      "LastUpdate": "2023-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "75834-238-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (75834-238-05) ",
      "NDC11Code": "75834-0238-05",
      "ProductNDC": "75834-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200903",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210628",
      "LabelerName": "NIVAGEN PHARMACEUTICALS, INC.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200903",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib capsule are indicated.",
      "Description": "Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
    },
    {
      "NDCCode": "76282-238-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (76282-238-05) ",
      "NDC11Code": "76282-0238-05",
      "ProductNDC": "76282-238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate",
      "NonProprietaryName": "Amlodipine Besylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077955",
      "LabelerName": "Exelan Pharmaceuticals, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2023-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20071102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. , 2  Coronary Artery Disease (1.2)  Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
      "Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
    },
    {
      "NDCCode": "76470-005-05",
      "PackageDescription": "238 g in 1 BOTTLE (76470-005-05) ",
      "NDC11Code": "76470-0005-05",
      "ProductNDC": "76470-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ez2go",
      "NonProprietaryName": "Polyethylene Glycol 3350",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121020",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091077",
      "LabelerName": "Valley Medical Products,LLC",
      "SubstanceName": "POLYETHYLENE GLYCOL 3350",
      "StrengthNumber": "17",
      "StrengthUnit": "g/17g",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20121020",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61314-012-05",
      "PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (61314-012-05)",
      "NDC11Code": "61314-0012-05",
      "ProductNDC": "61314-012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ofloxacin",
      "NonProprietaryName": "Ofloxacin",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20040514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076231",
      "LabelerName": "Falcon Pharmaceuticals, Ltd.",
      "SubstanceName": "OFLOXACIN",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-05",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61314-014-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (61314-014-05)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "61314-0014-05",
      "ProductNDC": "61314-014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20080214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078031",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.",
      "Description": "Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cl2NO2Na. The structural formula of diclofenac sodium is. Diclofenac sodium ophthalmic solution, 0.1% is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution, 0.1% has a faint characteristic odor of castor oil."
    },
    {
      "NDCCode": "61314-015-05",
      "PackageDescription": "5 mL in 1 BOTTLE (61314-015-05)",
      "NDC11Code": "61314-0015-05",
      "ProductNDC": "61314-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ofloxacin",
      "NonProprietaryName": "Ofloxacin",
      "DosageFormName": "SOLUTION",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20080331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078222",
      "LabelerName": "Falcon Pharmaceuticals, Ltd.",
      "SubstanceName": "OFLOXACIN",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61314-018-05",
      "PackageDescription": "5 mL in 1 BOTTLE (61314-018-05)",
      "NDC11Code": "61314-0018-05",
      "ProductNDC": "61314-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20091105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078721",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "61314-019-05",
      "PackageDescription": "5 mL in 1 BOTTLE (61314-019-05) ",
      "NDC11Code": "61314-0019-05",
      "ProductNDC": "61314-019",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dorzolamide Hydrochloride",
      "NonProprietaryName": "Dorzolamide Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20090601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078981",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61314-126-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (61314-126-05)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "61314-0126-05",
      "ProductNDC": "61314-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20091105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076583",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20091105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
      "Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH."
    },
    {
      "NDCCode": "61314-143-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (61314-143-05)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "61314-0143-05",
      "ProductNDC": "61314-143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brimonidine Tartrate",
      "NonProprietaryName": "Brimonidine Tartrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20030917",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076254",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "BRIMONIDINE TARTRATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20030917",
      "SamplePackage": "N",
      "IndicationAndUsage": "Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.",
      "Description": "Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5. The structural formula is. In solution, brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. Each mL of brimonidine tartrate ophthalmic solution, 0.2% contains: Active: brimonidine tartrate 0.2% (2 mg/mL). Preservative: benzalkonium chloride 0.005% (0.05 mg). Inactives: citric acid; polyvinyl alcohol; purified water; sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH."
    },
    {
      "NDCCode": "61314-144-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (61314-144-05)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "61314-0144-05",
      "ProductNDC": "61314-144",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brimonidine Tartrate",
      "NonProprietaryName": "Brimonidine Tartrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20101002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021764",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "BRIMONIDINE TARTRATE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101002",
      "SamplePackage": "N",
      "IndicationAndUsage": "Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.",
      "Description": "Brimonidine tartrate ophthalmic solution, 0.15% (1.5 mg brimonidine tartrate per mL equivalent to 1.0 mg brimonidine free base per mL) is a relatively selective alpha-2-adrenergic agonist for topical ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It is a white to off-white. pale yellow to yellow powder. It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. The structural formula is. Formula: C11H10BrN5  C4H6O6. CAS Number: 59803-98-4. In solution, brimonidine tartrate ophthalmic solution, 0.15% has a clear, pale yellow to greenish yellow color. It has an osmolality of 250 - 350 mOsmol/kg and a pH of 6.6 to 7.4. Contains: Active ingredient: brimonidine tartrate 1.5 mg/mL (1.5 mg/mL), Preservative: Polyquad (polyquaternium-1) 0.001% (0.01 mg/mL), Inactives: boric acid, calcium chloride, magnesium chloride, mannitol, potassium chloride, povidone, purified water, sodium borate, sodium chloride, with hydrochloric acid and/or sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "61314-224-05",
      "PackageDescription": "5 mL in 1 BOTTLE (61314-224-05) ",
      "NDC11Code": "61314-0224-05",
      "ProductNDC": "61314-224",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Gfs",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION, GEL FORMING / DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19981224",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020963",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19981224",
      "SamplePackage": "N",
      "IndicationAndUsage": "Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
      "Description": "Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°.      405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears."
    },
    {
      "NDCCode": "61314-225-05",
      "PackageDescription": "5 mL in 1 BOTTLE (61314-225-05) ",
      "NDC11Code": "61314-0225-05",
      "ProductNDC": "61314-225",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Gfs",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION, GEL FORMING / DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19981224",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020963",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19981224",
      "SamplePackage": "N",
      "IndicationAndUsage": "Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
      "Description": "Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°.      405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears."
    },
    {
      "NDCCode": "61314-226-05",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61314-226-05)  / 5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "61314-0226-05",
      "ProductNDC": "61314-226",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Maleate",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19960115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074261",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19960115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
      "Description": "Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1   25°, 2  [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°), 3   405 nm."
    },
    {
      "NDCCode": "61314-227-05",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61314-227-05)  / 5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "61314-0227-05",
      "ProductNDC": "61314-227",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Maleate",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19960115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074262",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19960115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
      "Description": "Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1   25°, 2  [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°), 3   405 nm."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>61314-238-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE, PLASTIC (61314-238-05) </PackageDescription>
    <NDC11Code>61314-0238-05</NDC11Code>
    <ProductNDC>61314-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carteolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20000105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075476</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>CARTEOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.</IndicationAndUsage>
    <Description>Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water.</Description>
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  <NDC>
    <NDCCode>61314-238-10</NDCCode>
    <PackageDescription>10 mL in 1 BOTTLE, PLASTIC (61314-238-10) </PackageDescription>
    <NDC11Code>61314-0238-10</NDC11Code>
    <ProductNDC>61314-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carteolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20000105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075476</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>CARTEOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.</IndicationAndUsage>
    <Description>Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water.</Description>
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  <NDC>
    <NDCCode>61314-238-15</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE, PLASTIC (61314-238-15) </PackageDescription>
    <NDC11Code>61314-0238-15</NDC11Code>
    <ProductNDC>61314-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carteolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>CARTEOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.</IndicationAndUsage>
    <Description>Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows. C16H24N2O3HCI                      Mol. Wt. 328.84. Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water.</Description>
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  <NDC>
    <NDCCode>42571-238-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (42571-238-05) </PackageDescription>
    <NDC11Code>42571-0238-05</NDC11Code>
    <ProductNDC>42571-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
    <NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207435</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-11</LastUpdate>
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    <IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 140 mmHg at Week 8 With LOCF. Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 90 mmHg at Week 8 With LOCF. Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) &lt; 130 mmHg at Week 8 With LOCF. Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) &lt; 80 mmHg at Week 8 With LOCF. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP &lt;140 mmHg or &lt;130 mmHg or a DBP &lt;90 mmHg or &lt;80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 51% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of &lt;140 mmHg (systolic) and a 60% likelihood of achieving a goal of &lt;90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil  tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil  tablets 10/40 mg.</IndicationAndUsage>
    <Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil tablets is chemically described as 3-ethyl-5­ methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5­-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablets is chemically described as 2,3­ dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1H-tetrazol-5­-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C 29H 30N 6O 6. The structural formula for amlodipine besylate is:. The structural formula for olmesartan medoxomil is:. Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate USP, a white or almost white powder, and olmesartan medoxomil USP, a white to off white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is freely soluble in methanol, sparingly soluble in ethanol and slightly soluble in 2-propanol and in water. Olmesartan medoxomil is sparingly soluble in methanol and practically insoluble in water. Tablet Strength 5/20 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol and talc (opadry II white). Tablet Strength 5/40 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc and iron oxide yellow (opadry II yellow). Tablet Strength 10/20 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow and iron oxide red (opadry II beige). Tablet Strength 10/40 mg. Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose and the color coatings contain polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow, iron oxide red and ferrosoferric oxide/ iron oxide black (opadry II brown).</Description>
  </NDC>
  <NDC>
    <NDCCode>45861-083-05</NDCCode>
    <PackageDescription>238 d in 1 BOTTLE (45861-083-05) </PackageDescription>
    <NDC11Code>45861-0083-05</NDC11Code>
    <ProductNDC>45861-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090812</ApplicationNumber>
    <LabelerName>Pharmaceutica North America, Inc.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/d</StrengthUnit>
    <Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51407-238-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (51407-238-05) </PackageDescription>
    <NDC11Code>51407-0238-05</NDC11Code>
    <ProductNDC>51407-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19851119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070213</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
    <Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&amp;C Blue No. 1 Aluminum Lake and FD&amp;C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&amp;C Yellow No. 6 Aluminum Lake and D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>52584-238-05</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (52584-238-05)  &gt; 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>52584-0238-05</NDC11Code>
    <ProductNDC>52584-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20190906</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206781</ApplicationNumber>
    <LabelerName>General Injectables &amp; Vaccines, Inc.</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
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    <NDCCode>55150-238-05</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (55150-238-05)  / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>55150-0238-05</NDC11Code>
    <ProductNDC>55150-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
    <NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
    <StartMarketingDate>20151201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206781</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2.   Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3.     Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus.Acute rheumatic carditis. 4.    Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5.     Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6.    Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7.   Gastrointestinal diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8.   Respiratory diseases. Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9.  Hematologic disorders:. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. B. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Synovitis of osteoarthritis. Rheumatoid arthritis. Acute and subacute bursitis. Acute gouty arthritis. Epicondylitis. Acute nonspecific tenosynovitis. Post-traumatic osteoarthritis. C. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:. Keloids. Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).</IndicationAndUsage>
    <Description>Dexamethasone sodium phosphate injection USP is a sterile, clear, colorless solution, free from visible particles and a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula: Dexamethasone sodium phosphate injection USP is available in 4 mg/mL concentration. Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL, contains 4.37 mg of dexamethasone sodium phosphate, USP equivalent to 4 mg dexamethasone phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative). Made isotonic with sodium citrate. pH adjusted with citric acid or sodium hydroxide. ACTIONS — Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.</Description>
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    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (57237-238-05)</PackageDescription>
    <NDC11Code>57237-0238-05</NDC11Code>
    <ProductNDC>57237-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203494</ApplicationNumber>
    <LabelerName>Citron Pharma LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>66083-741-05</NDCCode>
    <PackageDescription>238 L in 1 DEWAR (66083-741-05)</PackageDescription>
    <NDC11Code>66083-0741-05</NDC11Code>
    <ProductNDC>66083-741</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19360101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Boone Drugs, Inc</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-04-03</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68382-238-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (68382-238-05) </PackageDescription>
    <NDC11Code>68382-0238-05</NDC11Code>
    <ProductNDC>68382-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone</ProprietaryName>
    <NonProprietaryName>Ziprasidone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208988</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-238-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-238-05) </PackageDescription>
    <NDC11Code>68428-0238-05</NDC11Code>
    <ProductNDC>68428-238</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aurum Bromatum</ProprietaryName>
    <NonProprietaryName>Gold Tribromide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>GOLD TRIBROMIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68998-238-05</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (68998-238-05)  / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68998-0238-05</NDC11Code>
    <ProductNDC>68998-238</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cold Max</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221005</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>MARC GLASSMAN, INC.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatnasal congestioncoughsinus congestion and pressure. helps clear nasal passages. promotes nasal and sinus drainage. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70412-238-05</NDCCode>
    <PackageDescription>5 mL in 1 TUBE (70412-238-05) </PackageDescription>
    <NDC11Code>70412-0238-05</NDC11Code>
    <ProductNDC>70412-238</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Spf30 Sunscreen</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Ocitsalate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Zhejiang Ayan Biotech Co., Ltd.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE</SubstanceName>
    <StrengthNumber>30; 100; 100; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70412-817-05</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (70412-817-05)  *  1 BOTTLE in 1 BOX (70412-119-05)  / 5 mL in 1 BOTTLE *  5 mL in 1 TUBE (70412-238-05) </PackageDescription>
    <NDC11Code>70412-0817-05</NDC11Code>
    <ProductNDC>70412-817</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Spf30 Sunscreen And Antibacterial Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol, Avobenzone, Homosalate, Octocrylene, Octisalate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Zhejiang Ayan Biotech Co., Ltd.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-11-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>75834-238-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (75834-238-05) </PackageDescription>
    <NDC11Code>75834-0238-05</NDC11Code>
    <ProductNDC>75834-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210628</ApplicationNumber>
    <LabelerName>NIVAGEN PHARMACEUTICALS, INC.</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib capsule are indicated.</IndicationAndUsage>
    <Description>Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-238-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-238-05) </PackageDescription>
    <NDC11Code>76282-0238-05</NDC11Code>
    <ProductNDC>76282-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077955</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. , 2  Coronary Artery Disease (1.2)  Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76470-005-05</NDCCode>
    <PackageDescription>238 g in 1 BOTTLE (76470-005-05) </PackageDescription>
    <NDC11Code>76470-0005-05</NDC11Code>
    <ProductNDC>76470-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ez2go</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091077</ApplicationNumber>
    <LabelerName>Valley Medical Products,LLC</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/17g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61314-012-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE, PLASTIC (61314-012-05)</PackageDescription>
    <NDC11Code>61314-0012-05</NDC11Code>
    <ProductNDC>61314-012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ofloxacin</ProprietaryName>
    <NonProprietaryName>Ofloxacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20040514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076231</ApplicationNumber>
    <LabelerName>Falcon Pharmaceuticals, Ltd.</LabelerName>
    <SubstanceName>OFLOXACIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-05</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61314-014-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61314-014-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61314-0014-05</NDC11Code>
    <ProductNDC>61314-014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20080214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078031</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.</IndicationAndUsage>
    <Description>Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cl2NO2Na. The structural formula of diclofenac sodium is. Diclofenac sodium ophthalmic solution, 0.1% is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution, 0.1% has a faint characteristic odor of castor oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-015-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61314-015-05)</PackageDescription>
    <NDC11Code>61314-0015-05</NDC11Code>
    <ProductNDC>61314-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ofloxacin</ProprietaryName>
    <NonProprietaryName>Ofloxacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20080331</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078222</ApplicationNumber>
    <LabelerName>Falcon Pharmaceuticals, Ltd.</LabelerName>
    <SubstanceName>OFLOXACIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61314-018-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61314-018-05)</PackageDescription>
    <NDC11Code>61314-0018-05</NDC11Code>
    <ProductNDC>61314-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20091105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078721</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61314-019-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61314-019-05) </PackageDescription>
    <NDC11Code>61314-0019-05</NDC11Code>
    <ProductNDC>61314-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dorzolamide Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20090601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078981</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61314-126-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61314-126-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61314-0126-05</NDC11Code>
    <ProductNDC>61314-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20091105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076583</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
    <Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-143-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61314-143-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61314-0143-05</NDC11Code>
    <ProductNDC>61314-143</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20030917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076254</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20030917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5. The structural formula is. In solution, brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. Each mL of brimonidine tartrate ophthalmic solution, 0.2% contains: Active: brimonidine tartrate 0.2% (2 mg/mL). Preservative: benzalkonium chloride 0.005% (0.05 mg). Inactives: citric acid; polyvinyl alcohol; purified water; sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-144-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (61314-144-05)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>61314-0144-05</NDC11Code>
    <ProductNDC>61314-144</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20101002</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021764</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution, 0.15% (1.5 mg brimonidine tartrate per mL equivalent to 1.0 mg brimonidine free base per mL) is a relatively selective alpha-2-adrenergic agonist for topical ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It is a white to off-white. pale yellow to yellow powder. It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. The structural formula is. Formula: C11H10BrN5  C4H6O6. CAS Number: 59803-98-4. In solution, brimonidine tartrate ophthalmic solution, 0.15% has a clear, pale yellow to greenish yellow color. It has an osmolality of 250 - 350 mOsmol/kg and a pH of 6.6 to 7.4. Contains: Active ingredient: brimonidine tartrate 1.5 mg/mL (1.5 mg/mL), Preservative: Polyquad (polyquaternium-1) 0.001% (0.01 mg/mL), Inactives: boric acid, calcium chloride, magnesium chloride, mannitol, potassium chloride, povidone, purified water, sodium borate, sodium chloride, with hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-224-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61314-224-05) </PackageDescription>
    <NDC11Code>61314-0224-05</NDC11Code>
    <ProductNDC>61314-224</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Gfs</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19981224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020963</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19981224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°.      405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-225-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE (61314-225-05) </PackageDescription>
    <NDC11Code>61314-0225-05</NDC11Code>
    <ProductNDC>61314-225</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Gfs</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19981224</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020963</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19981224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°.      405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-226-05</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61314-226-05)  / 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>61314-0226-05</NDC11Code>
    <ProductNDC>61314-226</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19960115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074261</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1   25°, 2  [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°), 3   405 nm.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-227-05</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61314-227-05)  / 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>61314-0227-05</NDC11Code>
    <ProductNDC>61314-227</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19960115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074262</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 1   25°, 2  [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°), 3   405 nm.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>61314-238-05</NDCCode><ProprietaryName>Carteolol Hydrochloride</ProprietaryName><NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61314-238-10</NDCCode><ProprietaryName>Carteolol Hydrochloride</ProprietaryName><NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61314-238-15</NDCCode><ProprietaryName>Carteolol Hydrochloride</ProprietaryName><NonProprietaryName>Carteolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-238-05</NDCCode><ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>45861-083-05</NDCCode><ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName></NDC><NDC><NDCCode>51407-238-05</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>52584-238-05</NDCCode><ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName><NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>55150-238-05</NDCCode><ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName><NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>57237-238-05</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>66083-741-05</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>68382-238-05</NDCCode><ProprietaryName>Ziprasidone</ProprietaryName><NonProprietaryName>Ziprasidone</NonProprietaryName></NDC><NDC><NDCCode>68428-238-05</NDCCode><ProprietaryName>Aurum Bromatum</ProprietaryName><NonProprietaryName>Gold Tribromide</NonProprietaryName></NDC><NDC><NDCCode>68998-238-05</NDCCode><ProprietaryName>Cold Max</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70412-238-05</NDCCode><ProprietaryName>Spf30 Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Ocitsalate</NonProprietaryName></NDC><NDC><NDCCode>70412-817-05</NDCCode><ProprietaryName>Spf30 Sunscreen And Antibacterial Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol, Avobenzone, Homosalate, Octocrylene, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>75834-238-05</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>76282-238-05</NDCCode><ProprietaryName>Amlodipine Besylate</ProprietaryName><NonProprietaryName>Amlodipine Besylate</NonProprietaryName></NDC><NDC><NDCCode>76470-005-05</NDCCode><ProprietaryName>Ez2go</ProprietaryName><NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName></NDC><NDC><NDCCode>61314-012-05</NDCCode><ProprietaryName>Ofloxacin</ProprietaryName><NonProprietaryName>Ofloxacin</NonProprietaryName></NDC><NDC><NDCCode>61314-014-05</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>61314-015-05</NDCCode><ProprietaryName>Ofloxacin</ProprietaryName><NonProprietaryName>Ofloxacin</NonProprietaryName></NDC><NDC><NDCCode>61314-018-05</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>61314-019-05</NDCCode><ProprietaryName>Dorzolamide Hydrochloride</ProprietaryName><NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>61314-126-05</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>61314-143-05</NDCCode><ProprietaryName>Brimonidine Tartrate</ProprietaryName><NonProprietaryName>Brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>61314-144-05</NDCCode><ProprietaryName>Brimonidine Tartrate</ProprietaryName><NonProprietaryName>Brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>61314-224-05</NDCCode><ProprietaryName>Timolol Gfs</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>61314-225-05</NDCCode><ProprietaryName>Timolol Gfs</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>61314-226-05</NDCCode><ProprietaryName>Timolol Maleate</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>61314-227-05</NDCCode><ProprietaryName>Timolol Maleate</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
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      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
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      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
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      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
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      "PracticeLocationAddressCityName": "REDMOND",
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      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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