{
"NDC": [
{
"NDCCode": "68071-2272-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (68071-2272-5) / 5 mL in 1 BOTTLE",
"NDC11Code": "68071-2272-05",
"ProductNDC": "68071-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20170628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207444",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201007",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.",
"Description": "Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C 18H 37N 5O 9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine."
},
{
"NDCCode": "15751-2272-5",
"PackageDescription": "1 TUBE in 1 BOX (15751-2272-5) / 15 g in 1 TUBE",
"NDC11Code": "15751-2272-05",
"ProductNDC": "15751-2272",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120726",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Eminence Organic Skin Care",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "6; 4.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170627",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions."
},
{
"NDCCode": "36987-2272-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2272-1)",
"NDC11Code": "36987-2272-01",
"ProductNDC": "36987-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Annual Blue Grass",
"NonProprietaryName": "Annual Blue Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POA ANNUA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "50090-2272-0",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (50090-2272-0) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "50090-2272-00",
"ProductNDC": "50090-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novolog Mix 70/30",
"NonProprietaryName": "Insulin Aspart",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20020911",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021172",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151215",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: 1 NOVOLOG MIX 70/30 is not recommended for the treatment of diabetic ketoacidosis., 2 The proportions of rapid-acting and long-acting insulins in NOVOLOG MIX 70/30 are fixed and do not allow for basal versus prandial dose adjustments.",
"Description": "Insulin aspart protamine and insulin aspart is a human insulin analog containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast). Insulin aspart has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart. NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart) is a uniform, white and cloudy, sterile injectable suspension for subcutaneous use. Each mL contains 100 units of insulin aspart and the inactive ingredients: disodium hydrogen phosphate dihydrate (1.25 mg), glycerol (16.0 mg), metacresol (1.72 mg), phenol (1.50 mg), protamine sulfate (0.32 mg), sodium chloride (0.877 mg), zinc (19.6 mcg), and Water for Injection, USP. NOVOLOG MIX 70/30 has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "71335-2272-5",
"PackageDescription": "50 TABLET in 1 BOTTLE (71335-2272-5) ",
"NDC11Code": "71335-2272-05",
"ProductNDC": "71335-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040864",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Butalbital, USP..............................................................50 mg. Acetaminophen, USP....................................................325 mg. Caffeine, USP................................................................40 mg. Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate and magnesium stearate. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:. C 11H 16N 2O 3 M.W. = 224.26. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. = 151.16. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula. C 8H 10N 4O 2 M.W. = 194.19."
},
{
"NDCCode": "0093-2272-34",
"PackageDescription": "20 TABLET, CHEWABLE in 1 BOTTLE (0093-2272-34) ",
"NDC11Code": "00093-2272-34",
"ProductNDC": "0093-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20050210",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065205",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "400; 57",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050210",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections – caused by beta–lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. .",
"Description": "Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is (2S,5R,6R)–6–[(R)–(–)–2–Amino–2–(p–hydroxyphenyl)acetamido]–3,3–dimethyl–7–oxo–4–thia–1–azabicyclo[3.2.0]heptane–2–carboxylic acid trihydrate and has the following structural formula. C16H19N3O5S3H2O M.W. 419.45. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. Chemically, clavulanate potassium, USP is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula. C8H8KNO5 M.W. 237.25. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)."
},
{
"NDCCode": "0781-2272-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2272-01)",
"NDC11Code": "00781-2272-01",
"ProductNDC": "0781-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0781-2272-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (0781-2272-10)",
"NDC11Code": "00781-2272-10",
"ProductNDC": "0781-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "15751-2272-2",
"PackageDescription": "1 JAR in 1 BOX (15751-2272-2) / 60 g in 1 JAR",
"NDC11Code": "15751-2272-02",
"ProductNDC": "15751-2272",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120726",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Eminence Organic Skin Care",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "6; 4.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170627",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions."
},
{
"NDCCode": "15751-2272-8",
"PackageDescription": "1 JAR in 1 BOX (15751-2272-8) / 250 g in 1 JAR",
"NDC11Code": "15751-2272-08",
"ProductNDC": "15751-2272",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120726",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Eminence Organic Skin Care",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "6; 4.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170627",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions."
},
{
"NDCCode": "54473-337-04",
"PackageDescription": "93.5 g in 1 TUBE (54473-337-04) ",
"NDC11Code": "54473-0337-04",
"ProductNDC": "54473-337",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exceed Total Care Sensitive",
"ProprietaryNameSuffix": "Spearmint Tooth Polish",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Melaleuca, Inc",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": ".2272; 4.675",
"StrengthUnit": "g/93.5g; g/93.5g",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220108",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 aids in the prevention of dental cavaties, 2 helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
},
{
"NDCCode": "54473-340-01",
"PackageDescription": "93.5 g in 1 TUBE (54473-340-01) ",
"NDC11Code": "54473-0340-01",
"ProductNDC": "54473-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exceed Total Care Sensitive",
"ProprietaryNameSuffix": "Peppermint Tooth Polish",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Melaleuca, Inc",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": ".2272; 4.675",
"StrengthUnit": "g/93.5g; g/93.5g",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221110",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 aids in the prevention of dental cavaties, 2 helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
},
{
"NDCCode": "58118-2272-0",
"PackageDescription": "1 CAPSULE in 1 PACKET (58118-2272-0)",
"NDC11Code": "58118-2272-00",
"ProductNDC": "58118-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02",
"IndicationAndUsage": "Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide."
},
{
"NDCCode": "58118-2272-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (58118-2272-3)",
"NDC11Code": "58118-2272-03",
"ProductNDC": "58118-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02",
"IndicationAndUsage": "Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide."
},
{
"NDCCode": "58118-2272-8",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (58118-2272-8)",
"NDC11Code": "58118-2272-08",
"ProductNDC": "58118-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02",
"IndicationAndUsage": "Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide."
},
{
"NDCCode": "58118-2272-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (58118-2272-9)",
"NDC11Code": "58118-2272-09",
"ProductNDC": "58118-2272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950303",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020364",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02",
"IndicationAndUsage": "Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).",
"Description": "Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide."
},
{
"NDCCode": "68071-1212-5",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (68071-1212-5) ",
"NDC11Code": "68071-1212-05",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1330-5",
"PackageDescription": "25 TABLET in 1 BOTTLE (68071-1330-5) ",
"NDC11Code": "68071-1330-05",
"ProductNDC": "68071-1330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20160829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208191",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09."
},
{
"NDCCode": "68071-1332-5",
"PackageDescription": "15 mL in 1 BOX (68071-1332-5)",
"NDC11Code": "68071-1332-05",
"ProductNDC": "68071-1332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proparacaine Hydrochloride",
"NonProprietaryName": "Proparacaine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19950929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040074",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "PROPARACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Local Anesthesia [PE],Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68071-1333-5",
"PackageDescription": "25 g in 1 BOX (68071-1333-5) ",
"NDC11Code": "68071-1333-05",
"ProductNDC": "68071-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silver Sulfadiazine",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851223",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018810",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170804",
"SamplePackage": "N",
"IndicationAndUsage": "Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
"Description": "Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:. Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative."
},
{
"NDCCode": "68071-1395-5",
"PackageDescription": "45 CAPSULE in 1 BOTTLE (68071-1395-5) ",
"NDC11Code": "68071-1395-05",
"ProductNDC": "68071-1395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "68071-1513-5",
"PackageDescription": "3.5 g in 1 BOX (68071-1513-5) ",
"NDC11Code": "68071-1513-05",
"ProductNDC": "68071-1513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentak",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20060508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064093",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190205",
"SamplePackage": "N",
"IndicationAndUsage": "Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.",
"Description": "GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:."
},
{
"NDCCode": "68071-1525-5",
"PackageDescription": "200 AEROSOL, METERED in 1 BOX (68071-1525-5) ",
"NDC11Code": "68071-1525-05",
"ProductNDC": "68071-1525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20121203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170804",
"SamplePackage": "N",
"IndicationAndUsage": "PROAIR HFA Inhalation Aerosol is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2) .",
"Description": "The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1-[( tert-butylamino) methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant."
},
{
"NDCCode": "68071-1527-5",
"PackageDescription": "15 mL in 1 BOTTLE (68071-1527-5) ",
"NDC11Code": "68071-1527-05",
"ProductNDC": "68071-1527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
},
{
"NDCCode": "68071-1528-5",
"PackageDescription": "15 mL in 1 BOTTLE (68071-1528-5) ",
"NDC11Code": "68071-1528-05",
"ProductNDC": "68071-1528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
},
{
"NDCCode": "68071-1530-5",
"PackageDescription": "5 mL in 1 BOX (68071-1530-5) ",
"NDC11Code": "68071-1530-05",
"ProductNDC": "68071-1530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20080320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170712",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1538-5",
"PackageDescription": "45 g in 1 BOX (68071-1538-5) ",
"NDC11Code": "68071-1538-05",
"ProductNDC": "68071-1538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078541",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone furoate cream USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30CI 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate cream USP, 0.1% contains: 1 mg mometasone furoate USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water."
},
{
"NDCCode": "68071-1550-6",
"PackageDescription": "2.5 mL in 1 VIAL (68071-1550-6) ",
"NDC11Code": "68071-1550-06",
"ProductNDC": "68071-1550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1552-5",
"PackageDescription": "50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-1552-5) ",
"NDC11Code": "68071-1552-05",
"ProductNDC": "68071-1552",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Reliever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20020430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076200",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170929",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1563-5",
"PackageDescription": "5 mL in 1 BOTTLE (68071-1563-5)",
"NDC11Code": "68071-1563-05",
"ProductNDC": "68071-1563",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074466",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-04-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68071-2272-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68071-2272-5) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68071-2272-05</NDC11Code>
<ProductNDC>68071-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20170628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207444</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.</IndicationAndUsage>
<Description>Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C 18H 37N 5O 9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.</Description>
</NDC>
<NDC>
<NDCCode>15751-2272-5</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (15751-2272-5) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>15751-2272-05</NDC11Code>
<ProductNDC>15751-2272</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Eminence Organic Skin Care</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 4.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-2272-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2272-1)</PackageDescription>
<NDC11Code>36987-2272-01</NDC11Code>
<ProductNDC>36987-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Annual Blue Grass</ProprietaryName>
<NonProprietaryName>Annual Blue Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POA ANNUA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>50090-2272-0</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (50090-2272-0) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>50090-2272-00</NDC11Code>
<ProductNDC>50090-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novolog Mix 70/30</ProprietaryName>
<NonProprietaryName>Insulin Aspart</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020911</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021172</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: 1 NOVOLOG MIX 70/30 is not recommended for the treatment of diabetic ketoacidosis., 2 The proportions of rapid-acting and long-acting insulins in NOVOLOG MIX 70/30 are fixed and do not allow for basal versus prandial dose adjustments.</IndicationAndUsage>
<Description>Insulin aspart protamine and insulin aspart is a human insulin analog containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast). Insulin aspart has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart. NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart) is a uniform, white and cloudy, sterile injectable suspension for subcutaneous use. Each mL contains 100 units of insulin aspart and the inactive ingredients: disodium hydrogen phosphate dihydrate (1.25 mg), glycerol (16.0 mg), metacresol (1.72 mg), phenol (1.50 mg), protamine sulfate (0.32 mg), sodium chloride (0.877 mg), zinc (19.6 mcg), and Water for Injection, USP. NOVOLOG MIX 70/30 has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>71335-2272-5</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (71335-2272-5) </PackageDescription>
<NDC11Code>71335-2272-05</NDC11Code>
<ProductNDC>71335-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040864</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Butalbital, USP..............................................................50 mg. Acetaminophen, USP....................................................325 mg. Caffeine, USP................................................................40 mg. Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate and magnesium stearate. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:. C 11H 16N 2O 3 M.W. = 224.26. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. = 151.16. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula. C 8H 10N 4O 2 M.W. = 194.19.</Description>
</NDC>
<NDC>
<NDCCode>0093-2272-34</NDCCode>
<PackageDescription>20 TABLET, CHEWABLE in 1 BOTTLE (0093-2272-34) </PackageDescription>
<NDC11Code>00093-2272-34</NDC11Code>
<ProductNDC>0093-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050210</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065205</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>400; 57</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050210</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. , 2 Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis. , 3 Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis. , 4 Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. , 5 Urinary Tract Infections – caused by beta–lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. .</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is (2S,5R,6R)–6–[(R)–(–)–2–Amino–2–(p–hydroxyphenyl)acetamido]–3,3–dimethyl–7–oxo–4–thia–1–azabicyclo[3.2.0]heptane–2–carboxylic acid trihydrate and has the following structural formula. C16H19N3O5S3H2O M.W. 419.45. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. Chemically, clavulanate potassium, USP is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula. C8H8KNO5 M.W. 237.25. Amoxicillin and Clavulanate Potassium Tablets, USP: 1 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium)., 2 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium).</Description>
</NDC>
<NDC>
<NDCCode>0781-2272-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2272-01)</PackageDescription>
<NDC11Code>00781-2272-01</NDC11Code>
<ProductNDC>0781-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-2272-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (0781-2272-10)</PackageDescription>
<NDC11Code>00781-2272-10</NDC11Code>
<ProductNDC>0781-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15751-2272-2</NDCCode>
<PackageDescription>1 JAR in 1 BOX (15751-2272-2) / 60 g in 1 JAR</PackageDescription>
<NDC11Code>15751-2272-02</NDC11Code>
<ProductNDC>15751-2272</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Eminence Organic Skin Care</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 4.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15751-2272-8</NDCCode>
<PackageDescription>1 JAR in 1 BOX (15751-2272-8) / 250 g in 1 JAR</PackageDescription>
<NDC11Code>15751-2272-08</NDC11Code>
<ProductNDC>15751-2272</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eminence Bright Skin Moisturizer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Eminence Organic Skin Care</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 4.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54473-337-04</NDCCode>
<PackageDescription>93.5 g in 1 TUBE (54473-337-04) </PackageDescription>
<NDC11Code>54473-0337-04</NDC11Code>
<ProductNDC>54473-337</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exceed Total Care Sensitive</ProprietaryName>
<ProprietaryNameSuffix>Spearmint Tooth Polish</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate And Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Melaleuca, Inc</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.2272; 4.675</StrengthNumber>
<StrengthUnit>g/93.5g; g/93.5g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 aids in the prevention of dental cavaties, 2 helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54473-340-01</NDCCode>
<PackageDescription>93.5 g in 1 TUBE (54473-340-01) </PackageDescription>
<NDC11Code>54473-0340-01</NDC11Code>
<ProductNDC>54473-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exceed Total Care Sensitive</ProprietaryName>
<ProprietaryNameSuffix>Peppermint Tooth Polish</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate And Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Melaleuca, Inc</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.2272; 4.675</StrengthNumber>
<StrengthUnit>g/93.5g; g/93.5g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 aids in the prevention of dental cavaties, 2 helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58118-2272-0</NDCCode>
<PackageDescription>1 CAPSULE in 1 PACKET (58118-2272-0)</PackageDescription>
<NDC11Code>58118-2272-00</NDC11Code>
<ProductNDC>58118-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
<IndicationAndUsage>Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58118-2272-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (58118-2272-3)</PackageDescription>
<NDC11Code>58118-2272-03</NDC11Code>
<ProductNDC>58118-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
<IndicationAndUsage>Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58118-2272-8</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (58118-2272-8)</PackageDescription>
<NDC11Code>58118-2272-08</NDC11Code>
<ProductNDC>58118-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
<IndicationAndUsage>Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58118-2272-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (58118-2272-9)</PackageDescription>
<NDC11Code>58118-2272-09</NDC11Code>
<ProductNDC>58118-2272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950303</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020364</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
<IndicationAndUsage>Amlodipine Besylate and Benazepril Hydrochloride Capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).</IndicationAndUsage>
<Description>Amlodipine besylate and benazepril hydrochloride capsules are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine besylate and benazepril hydrochloride capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg. The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-5</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (68071-1212-5) </PackageDescription>
<NDC11Code>68071-1212-05</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1330-5</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (68071-1330-5) </PackageDescription>
<NDC11Code>68071-1330-05</NDC11Code>
<ProductNDC>68071-1330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20160829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208191</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>68071-1332-5</NDCCode>
<PackageDescription>15 mL in 1 BOX (68071-1332-5)</PackageDescription>
<NDC11Code>68071-1332-05</NDC11Code>
<ProductNDC>68071-1332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proparacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Proparacaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19950929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040074</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>PROPARACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Local Anesthesia [PE],Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1333-5</NDCCode>
<PackageDescription>25 g in 1 BOX (68071-1333-5) </PackageDescription>
<NDC11Code>68071-1333-05</NDC11Code>
<ProductNDC>68071-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silver Sulfadiazine</ProprietaryName>
<NonProprietaryName>Silver Sulfadiazine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851223</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018810</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>SILVER SULFADIAZINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.</IndicationAndUsage>
<Description>Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:. Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>68071-1395-5</NDCCode>
<PackageDescription>45 CAPSULE in 1 BOTTLE (68071-1395-5) </PackageDescription>
<NDC11Code>68071-1395-05</NDC11Code>
<ProductNDC>68071-1395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>68071-1513-5</NDCCode>
<PackageDescription>3.5 g in 1 BOX (68071-1513-5) </PackageDescription>
<NDC11Code>68071-1513-05</NDC11Code>
<ProductNDC>68071-1513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentak</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20060508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064093</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.</IndicationAndUsage>
<Description>GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>68071-1525-5</NDCCode>
<PackageDescription>200 AEROSOL, METERED in 1 BOX (68071-1525-5) </PackageDescription>
<NDC11Code>68071-1525-05</NDC11Code>
<ProductNDC>68071-1525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021457</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROAIR HFA Inhalation Aerosol is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2) .</IndicationAndUsage>
<Description>The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1-[( tert-butylamino) methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
</NDC>
<NDC>
<NDCCode>68071-1527-5</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (68071-1527-5) </PackageDescription>
<NDC11Code>68071-1527-05</NDC11Code>
<ProductNDC>68071-1527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
</NDC>
<NDC>
<NDCCode>68071-1528-5</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (68071-1528-5) </PackageDescription>
<NDC11Code>68071-1528-05</NDC11Code>
<ProductNDC>68071-1528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
</NDC>
<NDC>
<NDCCode>68071-1530-5</NDCCode>
<PackageDescription>5 mL in 1 BOX (68071-1530-5) </PackageDescription>
<NDC11Code>68071-1530-05</NDC11Code>
<ProductNDC>68071-1530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20080320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077689</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1538-5</NDCCode>
<PackageDescription>45 g in 1 BOX (68071-1538-5) </PackageDescription>
<NDC11Code>68071-1538-05</NDC11Code>
<ProductNDC>68071-1538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078541</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone furoate cream USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30CI 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate cream USP, 0.1% contains: 1 mg mometasone furoate USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68071-1550-6</NDCCode>
<PackageDescription>2.5 mL in 1 VIAL (68071-1550-6) </PackageDescription>
<NDC11Code>68071-1550-06</NDC11Code>
<ProductNDC>68071-1550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1552-5</NDCCode>
<PackageDescription>50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-1552-5) </PackageDescription>
<NDC11Code>68071-1552-05</NDC11Code>
<ProductNDC>68071-1552</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020430</StartMarketingDate>
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<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
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<SamplePackage>N</SamplePackage>
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<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
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