{
"NDC": [
{
"NDCCode": "64380-765-21",
"PackageDescription": "4 L in 1 JUG (64380-765-21) ",
"NDC11Code": "64380-0765-21",
"ProductNDC": "64380-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 And Electrolytes - Unflavored",
"NonProprietaryName": "Polyethylene Glycol 3350 And Electrolytes - Unflavored",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204558",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORATE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190110",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).",
"Description": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "21695-765-21",
"PackageDescription": "21 TABLET in 1 BOX, UNIT-DOSE (21695-765-21)",
"NDC11Code": "21695-0765-21",
"ProductNDC": "21695-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040256",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs 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 DiseasesDuring 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 StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere 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 DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo 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 DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone 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."
},
{
"NDCCode": "51655-765-21",
"PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (51655-765-21) ",
"NDC11Code": "51655-0765-21",
"ProductNDC": "51655-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080292",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210730",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions.",
"Description": "Each tablet for oral administration contains. Prednisone, USP.................................................5 mg, 10 mg and 20 mg. Inactive Ingredients. Prednisone tablets, USP of 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone tablets of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone, USP is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol."
},
{
"NDCCode": "68084-765-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-765-21) > 1 TABLET in 1 BLISTER PACK (68084-765-11) ",
"NDC11Code": "68084-0765-21",
"ProductNDC": "68084-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140531",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "American Health Packaging",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140531",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1) , 2 Adjunct therapy for heart failure ( 1.2) , 3 Treatment of Acute Myocardial Infarction ( 1.3) .",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn)."
},
{
"NDCCode": "64380-766-21",
"PackageDescription": "4 L in 1 JUG (64380-766-21) ",
"NDC11Code": "64380-0766-21",
"ProductNDC": "64380-766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor",
"NonProprietaryName": "Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204558",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190110",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).",
"Description": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "64380-767-21",
"PackageDescription": "4 L in 1 JUG (64380-767-21) ",
"NDC11Code": "64380-0767-21",
"ProductNDC": "64380-767",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 And Electrolyteswith Orange Flavor",
"NonProprietaryName": "Polyethylene Glycol 3350 And Electrolytes With Orange Flavor",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204558",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190110",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).",
"Description": "Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "64380-768-21",
"PackageDescription": "4 L in 1 JUG (64380-768-21) ",
"NDC11Code": "64380-0768-21",
"ProductNDC": "64380-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204559",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "420; 11.2; 5.72; 1.48",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.",
"Description": "For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl."
},
{
"NDCCode": "64380-769-21",
"PackageDescription": "4 L in 1 JUG (64380-769-21) ",
"NDC11Code": "64380-0769-21",
"ProductNDC": "64380-769",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204559",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "420; 11.2; 5.72; 1.48",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Alkalinizing Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.",
"Description": "For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl."
},
{
"NDCCode": "64380-770-21",
"PackageDescription": "4 L in 1 JUG (64380-770-21) ",
"NDC11Code": "64380-0770-21",
"ProductNDC": "64380-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204559",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE",
"StrengthNumber": "420; 11.2; 5.72; 1.48",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Alkalinizing Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150414",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.",
"Description": "For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl."
},
{
"NDCCode": "10096-0214-2",
"PackageDescription": "1 CASE in 1 CARTON (10096-0214-2) > 9 g in 1 CASE (10096-0214-1)",
"NDC11Code": "10096-0214-02",
"ProductNDC": "10096-0214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healthy Makeup",
"ProprietaryNameSuffix": "Cream-to-powder Foundation",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Avon Products, Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "765",
"StrengthUnit": "mg/9g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses: Helps prevent sunburn."
},
{
"NDCCode": "13537-765-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-765-02) > 2.2 g in 1 TUBE (13537-765-01)",
"NDC11Code": "13537-0765-02",
"ProductNDC": "13537-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Perfect Match Volumen",
"ProprietaryNameSuffix": "(vino Sublime) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150710",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".075",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "21695-765-48",
"PackageDescription": "48 TABLET in 1 BOX, UNIT-DOSE (21695-765-48)",
"NDC11Code": "21695-0765-48",
"ProductNDC": "21695-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040256",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs 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 DiseasesDuring 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 StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere 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 DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo 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 DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone 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."
},
{
"NDCCode": "37808-765-07",
"PackageDescription": "2 g in 1 BOTTLE, PUMP (37808-765-07) ",
"NDC11Code": "37808-0765-07",
"ProductNDC": "37808-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Sore Fever Blister Treatment",
"NonProprietaryName": "Docosanol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212385",
"LabelerName": "H E B",
"SubstanceName": "DOCOSANOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230707",
"SamplePackage": "N",
"IndicationAndUsage": "treats cold sores/fever blisters on the face or lips. shortens healing time and duration of symptoms:tingling, pain, burning, and/or itching."
},
{
"NDCCode": "57297-765-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (57297-765-02)",
"NDC11Code": "57297-0765-02",
"ProductNDC": "57297-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090245",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red."
},
{
"NDCCode": "57297-765-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (57297-765-06)",
"NDC11Code": "57297-0765-06",
"ProductNDC": "57297-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090245",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red."
},
{
"NDCCode": "57297-765-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (57297-765-09)",
"NDC11Code": "57297-0765-09",
"ProductNDC": "57297-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090245",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red."
},
{
"NDCCode": "57297-765-11",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (57297-765-11)",
"NDC11Code": "57297-0765-11",
"ProductNDC": "57297-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090245",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).",
"Description": "Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red."
},
{
"NDCCode": "62372-765-36",
"PackageDescription": "1 BOTTLE in 1 CARTON (62372-765-36) > 36 mL in 1 BOTTLE",
"NDC11Code": "62372-0765-36",
"ProductNDC": "62372-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infirst Gas Relief",
"ProprietaryNameSuffix": "Infants",
"NonProprietaryName": "Simethicone",
"DosageFormName": "EMULSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "INFIRST HEALTHCARE",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190805",
"SamplePackage": "N"
},
{
"NDCCode": "63187-765-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (63187-765-30) ",
"NDC11Code": "63187-0765-30",
"ProductNDC": "63187-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078296",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161101",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "63187-765-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (63187-765-60) ",
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"LabelerName": "Proficient Rx LP",
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"IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "63187-765-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63187-765-90) ",
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"ProductNDC": "63187-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078296",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20161101",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "65601-765-04",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (65601-765-04) ",
"NDC11Code": "65601-0765-04",
"ProductNDC": "65601-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Knuckle Under Medicated",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
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"LastUpdate": "2020-07-21",
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"StartMarketingDatePackage": "20160301",
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{
"NDCCode": "65601-765-06",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (65601-765-06) ",
"NDC11Code": "65601-0765-06",
"ProductNDC": "65601-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Knuckle Under Medicated",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
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"LastUpdate": "2020-07-21",
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"StartMarketingDatePackage": "20121112",
"SamplePackage": "N"
},
{
"NDCCode": "65601-765-55",
"PackageDescription": "208000 mL in 1 DRUM (65601-765-55) ",
"NDC11Code": "65601-0765-55",
"ProductNDC": "65601-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Knuckle Under Medicated",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20121112",
"SamplePackage": "N"
},
{
"NDCCode": "72288-765-40",
"PackageDescription": "355 mL in 1 BOTTLE (72288-765-40) ",
"NDC11Code": "72288-0765-40",
"ProductNDC": "72288-765",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260709",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "72611-765-10",
"PackageDescription": "10 VIAL in 1 CARTON (72611-765-10) / 20 mL in 1 VIAL (72611-765-01) ",
"NDC11Code": "72611-0765-10",
"ProductNDC": "72611-765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200508",
"EndMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205694",
"LabelerName": "Almaject, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200508",
"EndMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin hydrochloride for injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "87173-765-10",
"PackageDescription": "10 g in 1 BOTTLE (87173-765-10) ",
"NDC11Code": "87173-0765-10",
"ProductNDC": "87173-765",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251021",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hangzhou Jodomi Biotech Co.,Ltd",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-OCT-25"
},
{
"NDCCode": "87173-765-50",
"PackageDescription": "50 g in 1 BOTTLE (87173-765-50) ",
"NDC11Code": "87173-0765-50",
"ProductNDC": "87173-765",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251021",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hangzhou Jodomi Biotech Co.,Ltd",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-OCT-25"
},
{
"NDCCode": "87173-765-99",
"PackageDescription": "100 g in 1 BOTTLE (87173-765-99) ",
"NDC11Code": "87173-0765-99",
"ProductNDC": "87173-765",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251021",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hangzhou Jodomi Biotech Co.,Ltd",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-OCT-25"
},
{
"NDCCode": "64380-246-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-246-01) ",
"NDC11Code": "64380-0246-01",
"ProductNDC": "64380-246",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075938",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.",
"Description": "Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol."
}
]
}
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<PackageDescription>4 L in 1 JUG (64380-765-21) </PackageDescription>
<NDC11Code>64380-0765-21</NDC11Code>
<ProductNDC>64380-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 And Electrolytes - Unflavored</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350 And Electrolytes - Unflavored</NonProprietaryName>
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<StartMarketingDate>20190110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204558</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORATE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).</IndicationAndUsage>
<Description>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>21695-765-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOX, UNIT-DOSE (21695-765-21)</PackageDescription>
<NDC11Code>21695-0765-21</NDC11Code>
<ProductNDC>21695-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040256</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs 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 DiseasesDuring 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 StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere 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 DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo 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 DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone 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.</Description>
</NDC>
<NDC>
<NDCCode>51655-765-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE, PLASTIC (51655-765-21) </PackageDescription>
<NDC11Code>51655-0765-21</NDC11Code>
<ProductNDC>51655-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080292</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Prednisone, USP.................................................5 mg, 10 mg and 20 mg. Inactive Ingredients. Prednisone tablets, USP of 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone tablets of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone, USP is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.</Description>
</NDC>
<NDC>
<NDCCode>68084-765-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-765-21) > 1 TABLET in 1 BLISTER PACK (68084-765-11) </PackageDescription>
<NDC11Code>68084-0765-21</NDC11Code>
<ProductNDC>68084-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140531</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140531</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1) , 2 Adjunct therapy for heart failure ( 1.2) , 3 Treatment of Acute Myocardial Infarction ( 1.3) .</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
</NDC>
<NDC>
<NDCCode>64380-766-21</NDCCode>
<PackageDescription>4 L in 1 JUG (64380-766-21) </PackageDescription>
<NDC11Code>64380-0766-21</NDC11Code>
<ProductNDC>64380-766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204558</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).</IndicationAndUsage>
<Description>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>64380-767-21</NDCCode>
<PackageDescription>4 L in 1 JUG (64380-767-21) </PackageDescription>
<NDC11Code>64380-0767-21</NDC11Code>
<ProductNDC>64380-767</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 And Electrolyteswith Orange Flavor</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350 And Electrolytes With Orange Flavor</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204558</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).</IndicationAndUsage>
<Description>Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. NA+Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>64380-768-21</NDCCode>
<PackageDescription>4 L in 1 JUG (64380-768-21) </PackageDescription>
<NDC11Code>64380-0768-21</NDC11Code>
<ProductNDC>64380-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204559</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>420; 11.2; 5.72; 1.48</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.</IndicationAndUsage>
<Description>For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>64380-769-21</NDCCode>
<PackageDescription>4 L in 1 JUG (64380-769-21) </PackageDescription>
<NDC11Code>64380-0769-21</NDC11Code>
<ProductNDC>64380-769</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204559</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>420; 11.2; 5.72; 1.48</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.</IndicationAndUsage>
<Description>For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>64380-770-21</NDCCode>
<PackageDescription>4 L in 1 JUG (64380-770-21) </PackageDescription>
<NDC11Code>64380-0770-21</NDC11Code>
<ProductNDC>64380-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204559</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>420; 11.2; 5.72; 1.48</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater.</IndicationAndUsage>
<Description>For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>10096-0214-2</NDCCode>
<PackageDescription>1 CASE in 1 CARTON (10096-0214-2) > 9 g in 1 CASE (10096-0214-1)</PackageDescription>
<NDC11Code>10096-0214-02</NDC11Code>
<ProductNDC>10096-0214</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healthy Makeup</ProprietaryName>
<ProprietaryNameSuffix>Cream-to-powder Foundation</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Avon Products, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>765</StrengthNumber>
<StrengthUnit>mg/9g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-765-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-765-02) > 2.2 g in 1 TUBE (13537-765-01)</PackageDescription>
<NDC11Code>13537-0765-02</NDC11Code>
<ProductNDC>13537-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Perfect Match Volumen</ProprietaryName>
<ProprietaryNameSuffix>(vino Sublime) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150710</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-765-48</NDCCode>
<PackageDescription>48 TABLET in 1 BOX, UNIT-DOSE (21695-765-48)</PackageDescription>
<NDC11Code>21695-0765-48</NDC11Code>
<ProductNDC>21695-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040256</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs 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 DiseasesDuring 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 StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere 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 DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo 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 DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone 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.</Description>
</NDC>
<NDC>
<NDCCode>37808-765-07</NDCCode>
<PackageDescription>2 g in 1 BOTTLE, PUMP (37808-765-07) </PackageDescription>
<NDC11Code>37808-0765-07</NDC11Code>
<ProductNDC>37808-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Sore Fever Blister Treatment</ProprietaryName>
<NonProprietaryName>Docosanol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212385</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>DOCOSANOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats cold sores/fever blisters on the face or lips. shortens healing time and duration of symptoms:tingling, pain, burning, and/or itching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57297-765-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (57297-765-02)</PackageDescription>
<NDC11Code>57297-0765-02</NDC11Code>
<ProductNDC>57297-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090245</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>57297-765-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (57297-765-06)</PackageDescription>
<NDC11Code>57297-0765-06</NDC11Code>
<ProductNDC>57297-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090245</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>57297-765-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (57297-765-09)</PackageDescription>
<NDC11Code>57297-0765-09</NDC11Code>
<ProductNDC>57297-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090245</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>57297-765-11</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (57297-765-11)</PackageDescription>
<NDC11Code>57297-0765-11</NDC11Code>
<ProductNDC>57297-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090245</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine and valsartan tablet is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: 1 In patients not adequately controlled on monotherapy (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and valsartan tablet is a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, iron oxide yellow and titanium dioxide. Additionally, the 5/160 mg and 5/320 mg strengths contain iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>62372-765-36</NDCCode>
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<ProductNDC>62372-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>INFIRST HEALTHCARE</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-21</LastUpdate>
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-765-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63187-765-30) </PackageDescription>
<NDC11Code>63187-0765-30</NDC11Code>
<ProductNDC>63187-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078296</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>63187-765-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63187-765-60) </PackageDescription>
<NDC11Code>63187-0765-60</NDC11Code>
<ProductNDC>63187-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078296</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>63187-765-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63187-765-90) </PackageDescription>
<NDC11Code>63187-0765-90</NDC11Code>
<ProductNDC>63187-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078296</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of:. -Myocardial infarction. -Unstable angina. -Coronary revascularization procedures. (See Error! Hyperlink reference not valid.). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains >189 mg/dL or. 2. LDL-C remains >160 mg/dL and: : 1 there is a positive family history of premature cardiovascular disease or , 2 two or more other CVD risk factors are present in the adolescent patient .</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7, 8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets USP are supplied as 20 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
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<NDC>
<NDCCode>65601-765-04</NDCCode>
<PackageDescription>3780 mL in 1 BOTTLE, PLASTIC (65601-765-04) </PackageDescription>
<NDC11Code>65601-0765-04</NDC11Code>
<ProductNDC>65601-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Knuckle Under Medicated</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65601-765-06</NDCCode>
<PackageDescription>3780 mL in 1 BOTTLE, PLASTIC (65601-765-06) </PackageDescription>
<NDC11Code>65601-0765-06</NDC11Code>
<ProductNDC>65601-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Knuckle Under Medicated</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65601-765-55</NDCCode>
<PackageDescription>208000 mL in 1 DRUM (65601-765-55) </PackageDescription>
<NDC11Code>65601-0765-55</NDC11Code>
<ProductNDC>65601-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Knuckle Under Medicated</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72288-765-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (72288-765-40) </PackageDescription>
<NDC11Code>72288-0765-40</NDC11Code>
<ProductNDC>72288-765</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72611-765-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (72611-765-10) / 20 mL in 1 VIAL (72611-765-01) </PackageDescription>
<NDC11Code>72611-0765-10</NDC11Code>
<ProductNDC>72611-765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<EndMarketingDate>20241201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205694</ApplicationNumber>
<LabelerName>Almaject, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>87173-765-10</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (87173-765-10) </PackageDescription>
<NDC11Code>87173-0765-10</NDC11Code>
<ProductNDC>87173-765</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251021</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Hangzhou Jodomi Biotech Co.,Ltd</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>87173-765-50</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (87173-765-50) </PackageDescription>
<NDC11Code>87173-0765-50</NDC11Code>
<ProductNDC>87173-765</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251021</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Hangzhou Jodomi Biotech Co.,Ltd</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>87173-765-99</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (87173-765-99) </PackageDescription>
<NDC11Code>87173-0765-99</NDC11Code>
<ProductNDC>87173-765</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251021</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Hangzhou Jodomi Biotech Co.,Ltd</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64380-246-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-246-01) </PackageDescription>
<NDC11Code>64380-0246-01</NDC11Code>
<ProductNDC>64380-246</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075938</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.</IndicationAndUsage>
<Description>Propafenone hydrochloride tablets, USP are an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride (HCl) is 2'-[2-Hydroxy-3-(propylamino)- propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium starch glycolate, macrogol, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol.</Description>
</NDC>
</NDCList>