{
"NDC": [
{
"NDCCode": "63083-7127-1",
"PackageDescription": "29.5 mL in 1 BOTTLE, DROPPER (63083-7127-1) ",
"NDC11Code": "63083-7127-01",
"ProductNDC": "63083-7127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Solubilis",
"ProprietaryNameSuffix": "7127",
"NonProprietaryName": "Mercurius Solubilis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "MERCURIUS SOLUBILIS",
"StrengthNumber": "12",
"StrengthUnit": "[hp_X]/29.5mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "0904-7127-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7127-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7127-61",
"ProductNDC": "0904-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010829",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040362",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010829",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%."
},
{
"NDCCode": "10888-7127-1",
"PackageDescription": "1 BAG in 1 BOX (10888-7127-1) > 15000 CAPSULE, LIQUID FILLED in 1 BAG",
"NDC11Code": "10888-7127-01",
"ProductNDC": "10888-7127",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20100208",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Banner Pharmacaps Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "12598-7127-1",
"PackageDescription": "100 kg in 1 DRUM (12598-7127-1) ",
"NDC11Code": "12598-7127-01",
"ProductNDC": "12598-7127",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Balsalazide Disodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240709",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "PharmaZell GmbH",
"SubstanceName": "BALSALAZIDE DISODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "09-JUL-24"
},
{
"NDCCode": "48951-7127-5",
"PackageDescription": "60 g in 1 TUBE (48951-7127-5)",
"NDC11Code": "48951-7127-05",
"ProductNDC": "48951-7127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurialis Calendula Prunus Special Order",
"NonProprietaryName": "Mercurialis Calendula Prunus Special Order",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ONION; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MERCURIALIS PERENNIS; SLOE",
"StrengthNumber": "2; 2; 2; 2; 2",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions: FOR TOPICAL USE ONLY."
},
{
"NDCCode": "50090-7127-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-7127-0) ",
"NDC11Code": "50090-7127-00",
"ProductNDC": "50090-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207804",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240409",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.",
"Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets."
},
{
"NDCCode": "55154-7127-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-7127-0) > 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55154-7127-00",
"ProductNDC": "55154-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Cardinal Health",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130204",
"SamplePackage": "N"
},
{
"NDCCode": "68788-7127-1",
"PackageDescription": "125 mL in 1 BOTTLE (68788-7127-1) ",
"NDC11Code": "68788-7127-01",
"ProductNDC": "68788-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065162",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180323",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors: 1 antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following:- age 2 years or younger- daycare attendance.",
"Description": "Amoxicillin and Clavulanate Potassium for Oral Suspension USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. C16H19N3O5S 3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. C8H8KNO5 M.W. 237.25. Inactive Ingredients: Powder for oral suspension - aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, PB82 spray dried orange 739 flavor, sodium citrate, sodium saccharin, and xanthan gum [see Warnings and Precautions (5.6)]. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq."
},
{
"NDCCode": "68788-7127-7",
"PackageDescription": "75 mL in 1 BOTTLE (68788-7127-7) ",
"NDC11Code": "68788-7127-07",
"ProductNDC": "68788-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065162",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180323",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors: 1 antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following:- age 2 years or younger- daycare attendance.",
"Description": "Amoxicillin and Clavulanate Potassium for Oral Suspension USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. C16H19N3O5S 3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. C8H8KNO5 M.W. 237.25. Inactive Ingredients: Powder for oral suspension - aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, PB82 spray dried orange 739 flavor, sodium citrate, sodium saccharin, and xanthan gum [see Warnings and Precautions (5.6)]. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq."
},
{
"NDCCode": "71872-7127-1",
"PackageDescription": "1 VIAL, GLASS in 1 BAG (71872-7127-1) / 4 mL in 1 VIAL, GLASS",
"NDC11Code": "71872-7127-01",
"ProductNDC": "71872-7127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202747",
"LabelerName": "Medical Purchasing Solutions, LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro -N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows:. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "63083-1001-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1001-2) ",
"NDC11Code": "63083-1001-02",
"ProductNDC": "63083-1001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pets",
"ProprietaryNameSuffix": "1001",
"NonProprietaryName": "Pets",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N"
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{
"NDCCode": "63083-1022-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1022-2) ",
"NDC11Code": "63083-1022-02",
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
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"LabelerName": "Professional Complementary Health Formulas",
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"ProductNDC": "63083-1023",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACTIVATED CHARCOAL; ALOE SPICATA WHOLE; TOBACCO SMOKE; LIQUID PETROLEUM; NATURAL LATEX RUBBER; GUTTA PERCHA; TABTOXIN",
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"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19850815",
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{
"NDCCode": "63083-1024-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1024-2) ",
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"ProductNDC": "63083-1024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Southeast Regional",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACACIA; PLATANUS OCCIDENTALIS BARK; MILLETTIA PINNATA WHOLE; CYNODON DACTYLON WHOLE; BETULA OCCIDENTALIS POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ELM; PLANTAGO LANCEOLATA LEAF; SCHINUS TEREBINTHIFOLIA POLLEN; MEDICAGO SATIVA WHOLE; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA WHOLE; MELALEUCA VIRIDIFLORA WHOLE; JUNIPERUS SCOPULORUM POLLEN; WHITE MULBERRY; QUERCUS KELLOGGII POLLEN; AMARANTHUS HYBRIDUS LEAF; PINUS PONDEROSA POLLEN; AMBROSIA ARTEMISIIFOLIA WHOLE; RUMEX CRISPUS ROOT; SAGE; STENOTAPHRUM SECUNDATUM WHOLE; ENGLISH WALNUT; AMARANTHUS TUBERCULATUS POLLEN; FRAXINUS AMERICANA BARK",
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"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1025-2) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Airborne",
"ProprietaryNameSuffix": "1025",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
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"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; FELIS CATUS HAIR; HOUSE DUST; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; MEDICAGO SATIVA WHOLE; FRAXINUS LATIFOLIA WHOLE",
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"ProductNDC": "63083-1026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eastern Trees",
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]
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<?xml version="1.0" encoding="utf-8"?>
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<NDCCode>63083-7127-1</NDCCode>
<PackageDescription>29.5 mL in 1 BOTTLE, DROPPER (63083-7127-1) </PackageDescription>
<NDC11Code>63083-7127-01</NDC11Code>
<ProductNDC>63083-7127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Solubilis</ProprietaryName>
<ProprietaryNameSuffix>7127</ProprietaryNameSuffix>
<NonProprietaryName>Mercurius Solubilis</NonProprietaryName>
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<LabelerName>Professional Complementary Health Formulas</LabelerName>
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<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0904-7127-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7127-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7127-61</NDC11Code>
<ProductNDC>0904-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010829</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040362</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20010829</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol.The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43 The structural formula is represented below. Prednisone Tablets, USP are available in 5 strengths: 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg. In addition, each tablet contains the following inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow # 6, aluminum lake, HT 15-18%.</Description>
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<NDC11Code>10888-7127-01</NDC11Code>
<ProductNDC>10888-7127</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<StartMarketingDate>20100208</StartMarketingDate>
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<LabelerName>Banner Pharmacaps Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>12598-7127-1</NDCCode>
<PackageDescription>100 kg in 1 DRUM (12598-7127-1) </PackageDescription>
<NDC11Code>12598-7127-01</NDC11Code>
<ProductNDC>12598-7127</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Balsalazide Disodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240709</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>PharmaZell GmbH</LabelerName>
<SubstanceName>BALSALAZIDE DISODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-JUL-24</StartMarketingDatePackage>
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<PackageDescription>60 g in 1 TUBE (48951-7127-5)</PackageDescription>
<NDC11Code>48951-7127-05</NDC11Code>
<ProductNDC>48951-7127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurialis Calendula Prunus Special Order</ProprietaryName>
<NonProprietaryName>Mercurialis Calendula Prunus Special Order</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ONION; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MERCURIALIS PERENNIS; SLOE</SubstanceName>
<StrengthNumber>2; 2; 2; 2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: FOR TOPICAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-7127-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-7127-0) </PackageDescription>
<NDC11Code>50090-7127-00</NDC11Code>
<ProductNDC>50090-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207804</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide 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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.</IndicationAndUsage>
<Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 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 empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc, titanium dioxide. Red iron oxide, yellow iron oxide and black iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>55154-7127-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-7127-0) > 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-7127-00</NDC11Code>
<ProductNDC>55154-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-7127-1</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (68788-7127-1) </PackageDescription>
<NDC11Code>68788-7127-01</NDC11Code>
<ProductNDC>68788-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065162</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors: 1 antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following:- age 2 years or younger- daycare attendance.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium for Oral Suspension USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. C16H19N3O5S 3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. C8H8KNO5 M.W. 237.25. Inactive Ingredients: Powder for oral suspension - aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, PB82 spray dried orange 739 flavor, sodium citrate, sodium saccharin, and xanthan gum [see Warnings and Precautions (5.6)]. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq.</Description>
</NDC>
<NDC>
<NDCCode>68788-7127-7</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (68788-7127-7) </PackageDescription>
<NDC11Code>68788-7127-07</NDC11Code>
<ProductNDC>68788-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065162</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors: 1 antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following:- age 2 years or younger- daycare attendance.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium for Oral Suspension USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as. C16H19N3O5S 3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. C8H8KNO5 M.W. 237.25. Inactive Ingredients: Powder for oral suspension - aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, PB82 spray dried orange 739 flavor, sodium citrate, sodium saccharin, and xanthan gum [see Warnings and Precautions (5.6)]. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq.</Description>
</NDC>
<NDC>
<NDCCode>71872-7127-1</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 BAG (71872-7127-1) / 4 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>71872-7127-01</NDC11Code>
<ProductNDC>71872-7127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202747</ApplicationNumber>
<LabelerName>Medical Purchasing Solutions, LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro -N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows:. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>63083-1001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1001-2) </PackageDescription>
<NDC11Code>63083-1001-02</NDC11Code>
<ProductNDC>63083-1001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pets</ProprietaryName>
<ProprietaryNameSuffix>1001</ProprietaryNameSuffix>
<NonProprietaryName>Pets</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1002-2) </PackageDescription>
<NDC11Code>63083-1002-02</NDC11Code>
<ProductNDC>63083-1002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biting Insect Mix</ProprietaryName>
<ProprietaryNameSuffix>1002</ProprietaryNameSuffix>
<NonProprietaryName>Biting Insect Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Ant Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1003-2) </PackageDescription>
<NDC11Code>63083-1003-02</NDC11Code>
<ProductNDC>63083-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Caffeine Mix</ProprietaryName>
<ProprietaryNameSuffix>1003</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
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<SamplePackage>N</SamplePackage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
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<LabelerName>Professional Complementary Health Formulas</LabelerName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1022-2) </PackageDescription>
<NDC11Code>63083-1022-02</NDC11Code>
<ProductNDC>63083-1022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tropical</ProprietaryName>
<ProprietaryNameSuffix>1022</ProprietaryNameSuffix>
<NonProprietaryName>Tropical</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>ACACIA; AMARANTHUS HYBRIDUS LEAF; AMBROSIA ARTEMISIIFOLIA WHOLE; ATRIPLEX POLYCARPA WHOLE; BEEF LIVER; CORTICOTROPIN; CYNODON DACTYLON WHOLE; EUCALYPTUS GUM; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS SCOPULORUM POLLEN; OLEA EUROPAEA FLOWER; PLANTAGO LANCEOLATA LEAF; POA PRATENSIS TOP; SUS SCROFA ADRENAL GLAND; SYAGRUS ROMANZOFFIANA WHOLE; WHITE MULBERRY; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to sensitivity to common allergens in the tropics and Hawaii.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63083-1023-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1023-2) </PackageDescription>
<NDC11Code>63083-1023-02</NDC11Code>
<ProductNDC>63083-1023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smoke Mix</ProprietaryName>
<ProprietaryNameSuffix>1023</ProprietaryNameSuffix>
<NonProprietaryName>Smoke Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACTIVATED CHARCOAL; ALOE SPICATA WHOLE; TOBACCO SMOKE; LIQUID PETROLEUM; NATURAL LATEX RUBBER; GUTTA PERCHA; TABTOXIN</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1024-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1024-2) </PackageDescription>
<NDC11Code>63083-1024-02</NDC11Code>
<ProductNDC>63083-1024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Southeast Regional</ProprietaryName>
<ProprietaryNameSuffix>1024</ProprietaryNameSuffix>
<NonProprietaryName>Southeast Regional</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACACIA; PLATANUS OCCIDENTALIS BARK; MILLETTIA PINNATA WHOLE; CYNODON DACTYLON WHOLE; BETULA OCCIDENTALIS POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ELM; PLANTAGO LANCEOLATA LEAF; SCHINUS TEREBINTHIFOLIA POLLEN; MEDICAGO SATIVA WHOLE; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA WHOLE; MELALEUCA VIRIDIFLORA WHOLE; JUNIPERUS SCOPULORUM POLLEN; WHITE MULBERRY; QUERCUS KELLOGGII POLLEN; AMARANTHUS HYBRIDUS LEAF; PINUS PONDEROSA POLLEN; AMBROSIA ARTEMISIIFOLIA WHOLE; RUMEX CRISPUS ROOT; SAGE; STENOTAPHRUM SECUNDATUM WHOLE; ENGLISH WALNUT; AMARANTHUS TUBERCULATUS POLLEN; FRAXINUS AMERICANA BARK</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [Chemical/Ingredient], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Nut Proteins [EXT], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1025-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1025-2) </PackageDescription>
<NDC11Code>63083-1025-02</NDC11Code>
<ProductNDC>63083-1025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Airborne</ProprietaryName>
<ProprietaryNameSuffix>1025</ProprietaryNameSuffix>
<NonProprietaryName>Airborne</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; FELIS CATUS HAIR; HOUSE DUST; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; MEDICAGO SATIVA WHOLE; FRAXINUS LATIFOLIA WHOLE</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], House Dust [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized House Dust Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1026-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1026-2) </PackageDescription>
<NDC11Code>63083-1026-02</NDC11Code>
<ProductNDC>63083-1026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eastern Trees</ProprietaryName>
<ProprietaryNameSuffix>1026</ProprietaryNameSuffix>
<NonProprietaryName>Eastern Trees</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>FRAXINUS LATIFOLIA WHOLE; MILLETTIA PINNATA WHOLE; BETULA OCCIDENTALIS POLLEN; ELM; CARYA LACINIOSA BARK; ACER PENSYLVANICUM WHOLE; QUERCUS KELLOGGII POLLEN; LIRIODENDRON TULIPIFERA WHOLE; LIQUIDAMBAR STYRACIFLUA RESIN; SYMPHORICARPOS ALBUS FRUIT</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>