{
"NDC": [
{
"NDCCode": "38779-0669-4",
"PackageDescription": "25 g in 1 JAR (38779-0669-4) ",
"NDC11Code": "38779-0669-04",
"ProductNDC": "38779-0669",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130606",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-JUN-13"
},
{
"NDCCode": "38779-0669-3",
"PackageDescription": "5 g in 1 BOTTLE, GLASS (38779-0669-3) ",
"NDC11Code": "38779-0669-03",
"ProductNDC": "38779-0669",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130606",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-JUN-13"
},
{
"NDCCode": "38779-0669-5",
"PackageDescription": "100 g in 1 JAR (38779-0669-5) ",
"NDC11Code": "38779-0669-05",
"ProductNDC": "38779-0669",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130606",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-JUN-13"
},
{
"NDCCode": "38779-0669-6",
"PackageDescription": "1 g in 1 BOTTLE, GLASS (38779-0669-6) ",
"NDC11Code": "38779-0669-06",
"ProductNDC": "38779-0669",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130606",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-JUN-13"
},
{
"NDCCode": "15631-0669-1",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (15631-0669-1)",
"NDC11Code": "15631-0669-01",
"ProductNDC": "15631-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhus Toxicodendron",
"NonProprietaryName": "Rhus Toxicodendron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0669-4",
"PackageDescription": "250 TABLET in 1 CONTAINER (15631-0669-4)",
"NDC11Code": "15631-0669-04",
"ProductNDC": "15631-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhus Toxicodendron",
"NonProprietaryName": "Rhus Toxicodendron",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0669-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0669-4) ",
"NDC11Code": "37662-0669-04",
"ProductNDC": "37662-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Echinacea Angustifolia",
"NonProprietaryName": "Echinacea Angustifolia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220621",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA WHOLE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220621",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0669-4",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0669-4) ",
"NDC11Code": "71335-0669-04",
"ProductNDC": "71335-0669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078503",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211227",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride extended-release tablets, USP are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets also contain the following inert ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, dextrose, hypromellose, lactose, magnesium stearate, mannitol, polyethylene glycol, propylene glycol, tartaric acid, titanium dioxide, triacetin."
},
{
"NDCCode": "0078-0669-13",
"PackageDescription": "3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61) ",
"NDC11Code": "00078-0669-13",
"ProductNDC": "0078-0669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arzerra",
"NonProprietaryName": "Ofatumumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125326",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "OFATUMUMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Chronic Lymphocytic Leukemia (CLL). ARZERRA (ofatumumab) is indicated: : 1 in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)], 2 in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)], 3 for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)], 4 for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)].",
"Description": "ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20 mg/mL in single-use vials. Each single-use vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution. Inactive ingredients include: 10 mg/mL arginine, diluted hydrochloric acid, 0.019 mg/mL edetate disodium, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5."
},
{
"NDCCode": "0363-0669-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-0669-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00363-0669-01",
"ProductNDC": "0363-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen Tablets 500 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211013",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "WALGREENS",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211013",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves minor aches and pains due to: : 1 headache, 2 the common cold, 3 backache, 4 minor pain of arthritis, 5 toothache, 6 muscular aches, 7 premenstrual and menstrual cramps."
},
{
"NDCCode": "10237-669-44",
"PackageDescription": "4 CARTON in 1 PACKAGE (10237-669-44) / 1 TUBE in 1 CARTON / 127 g in 1 TUBE",
"NDC11Code": "10237-0669-44",
"ProductNDC": "10237-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensitive Teeth And Gums",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20171016",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
"StrengthNumber": "2.43; 50",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260703",
"SamplePackage": "N",
"IndicationAndUsage": "Use : 1 aids in the prevention of dental decay, 2 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact ."
},
{
"NDCCode": "10967-669-17",
"PackageDescription": "49 g in 1 JAR (10967-669-17) ",
"NDC11Code": "10967-0669-17",
"ProductNDC": "10967-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ceramide Premiere Broad Spectrum Spf 30",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, Octocrylene, Avobenzone",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "REVLON",
"SubstanceName": "OXYBENZONE; OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE",
"StrengthNumber": "4; 7.5; 3; 2; 5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170206",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun."
},
{
"NDCCode": "11673-669-44",
"PackageDescription": "257 g in 1 BOTTLE (11673-669-44) ",
"NDC11Code": "11673-0669-44",
"ProductNDC": "11673-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Fiber Therapy",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Target Corporation",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/5.79g",
"Status": "Deprecated",
"LastUpdate": "2019-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N"
},
{
"NDCCode": "11673-669-72",
"PackageDescription": "425 g in 1 BOTTLE (11673-669-72) ",
"NDC11Code": "11673-0669-72",
"ProductNDC": "11673-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Fiber Therapy",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/5.79g",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). generally produces bowel movement in 12-72 hours."
},
{
"NDCCode": "11673-669-91",
"PackageDescription": "660 g in 1 BOTTLE (11673-669-91) ",
"NDC11Code": "11673-0669-91",
"ProductNDC": "11673-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Fiber Therapy",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Target Corporation",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/5.79g",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity)."
},
{
"NDCCode": "25021-669-20",
"PackageDescription": "1 VIAL in 1 CARTON (25021-669-20) / 20 mL in 1 VIAL",
"NDC11Code": "25021-0669-20",
"ProductNDC": "25021-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201836",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .",
"Description": "Cisatracurium Besylate Injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R- [1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. : 1 The 5 mL single-dose vials contain 2 mg per mL cisatracurium, equivalent to 2.68 mg per mL cisatracurium besylate. , 2 The 10 mL multiple-dose vials contain 2 mg per mL cisatracurium, equivalent to 2.68 mg per mL cisatracurium besylate, and 0.9% benzyl alcohol as a preservative. , 3 The 20 mL single-dose vials contain 10 mg per mL cisatracurium, equivalent to 13.38 mg per mL cisatracurium besylate. ."
},
{
"NDCCode": "31722-669-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-669-60) ",
"NDC11Code": "31722-0669-60",
"ProductNDC": "31722-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212788",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220505",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as (±)N-(2,6-dimethylphenyl)-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperzin-1-yl]acetamide. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.55 g/mole, and the following structural formula:. Ranolazine is a white to off-white powder. Ranolazine is soluble in dichloromethane. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (contains sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose, and sodium hydroxide. In addition, the film coating contains the following inactive ingredients: FD&C blue #1, FD&C blue #2, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "41250-669-96",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (41250-669-96) ",
"NDC11Code": "41250-0669-96",
"ProductNDC": "41250-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Extra Strength",
"ProprietaryNameSuffix": "Wintergreen Flavor",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170310",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "MEIJER DISTRIBUTION INC",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170310",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "43063-669-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10) ",
"NDC11Code": "43063-0669-10",
"ProductNDC": "43063-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA207446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "43063-669-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14) ",
"NDC11Code": "43063-0669-14",
"ProductNDC": "43063-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160428",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "43063-669-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20) ",
"NDC11Code": "43063-0669-20",
"ProductNDC": "43063-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160428",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "43063-669-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30) ",
"NDC11Code": "43063-0669-30",
"ProductNDC": "43063-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160428",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "43063-669-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60) ",
"NDC11Code": "43063-0669-60",
"ProductNDC": "43063-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160428",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "43406-0669-2",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (43406-0669-2) ",
"NDC11Code": "43406-0669-02",
"ProductNDC": "43406-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Throat",
"NonProprietaryName": "Baptisia, Phytolacca, Hydrastis, Apis Mel, Arg Nit, Belladonna, Hepar Sulph Calc, Kali Bic, Lac Can, Lachesis, Merc Solub",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS",
"StrengthNumber": "4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180403",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**."
},
{
"NDCCode": "43742-0669-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0669-1)",
"NDC11Code": "43742-0669-01",
"ProductNDC": "43742-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circulation",
"NonProprietaryName": "Cactus Grandiflorus, Kali Carbonicum, Kalmia Latifolia, Arnica Montana, Glonoinum, Ignatia Amara, Lacticum Acidum, Ranunculus Bulbosus, Alpha-ketoglutaricum Acidum, Arsenicum Album, Heart (suis), Fumaricum Acidum, Hepar Suis, Malic Acid, Natrum Oxalaceticum, Phosphorus, Strophanthus Hispidus, Spigelia Anthelmia, Carbo Vegetabilis, Naja Tripudians, Cytomegalovirus, Epstein-barr Virus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151119",
"EndMarketingDate": "20201217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; ARNICA MONTANA; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACTIC ACID, DL-; RANUNCULUS BULBOSUS; OXOGLURIC ACID; ARSENIC TRIOXIDE; PORK HEART; FUMARIC ACID; PORK LIVER; MALIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS; STROPHANTHUS HISPIDUS SEED; SPIGELIA ANTHELMIA; ACTIVATED CHARCOAL; NAJA NAJA VENOM; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4",
"StrengthNumber": "3; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 12; 15; 17; 17",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-18",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "47335-669-13",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-13) ",
"NDC11Code": "47335-0669-13",
"ProductNDC": "47335-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
},
{
"NDCCode": "47335-669-18",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-18) ",
"NDC11Code": "47335-0669-18",
"ProductNDC": "47335-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
},
{
"NDCCode": "47335-669-19",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-19) ",
"NDC11Code": "47335-0669-19",
"ProductNDC": "47335-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
},
{
"NDCCode": "47335-669-81",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-81) ",
"NDC11Code": "47335-0669-81",
"ProductNDC": "47335-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
},
{
"NDCCode": "47335-669-83",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-83) ",
"NDC11Code": "47335-0669-83",
"ProductNDC": "47335-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090421",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>38779-0669-4</NDCCode>
<PackageDescription>25 g in 1 JAR (38779-0669-4) </PackageDescription>
<NDC11Code>38779-0669-04</NDC11Code>
<ProductNDC>38779-0669</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0669-3</NDCCode>
<PackageDescription>5 g in 1 BOTTLE, GLASS (38779-0669-3) </PackageDescription>
<NDC11Code>38779-0669-03</NDC11Code>
<ProductNDC>38779-0669</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0669-5</NDCCode>
<PackageDescription>100 g in 1 JAR (38779-0669-5) </PackageDescription>
<NDC11Code>38779-0669-05</NDC11Code>
<ProductNDC>38779-0669</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0669-6</NDCCode>
<PackageDescription>1 g in 1 BOTTLE, GLASS (38779-0669-6) </PackageDescription>
<NDC11Code>38779-0669-06</NDC11Code>
<ProductNDC>38779-0669</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUN-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15631-0669-1</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (15631-0669-1)</PackageDescription>
<NDC11Code>15631-0669-01</NDC11Code>
<ProductNDC>15631-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhus Toxicodendron</ProprietaryName>
<NonProprietaryName>Rhus Toxicodendron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0669-4</NDCCode>
<PackageDescription>250 TABLET in 1 CONTAINER (15631-0669-4)</PackageDescription>
<NDC11Code>15631-0669-04</NDC11Code>
<ProductNDC>15631-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhus Toxicodendron</ProprietaryName>
<NonProprietaryName>Rhus Toxicodendron</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0669-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0669-4) </PackageDescription>
<NDC11Code>37662-0669-04</NDC11Code>
<ProductNDC>37662-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Echinacea Angustifolia</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220621</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA WHOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0669-4</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0669-4) </PackageDescription>
<NDC11Code>71335-0669-04</NDC11Code>
<ProductNDC>71335-0669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078503</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride extended-release tablets, USP are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets also contain the following inert ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, dextrose, hypromellose, lactose, magnesium stearate, mannitol, polyethylene glycol, propylene glycol, tartaric acid, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0078-0669-13</NDCCode>
<PackageDescription>3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61) </PackageDescription>
<NDC11Code>00078-0669-13</NDC11Code>
<ProductNDC>0078-0669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arzerra</ProprietaryName>
<NonProprietaryName>Ofatumumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125326</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>OFATUMUMAB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chronic Lymphocytic Leukemia (CLL). ARZERRA (ofatumumab) is indicated: : 1 in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)], 2 in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)], 3 for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)], 4 for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20 mg/mL in single-use vials. Each single-use vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution. Inactive ingredients include: 10 mg/mL arginine, diluted hydrochloric acid, 0.019 mg/mL edetate disodium, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0363-0669-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-0669-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0669-01</NDC11Code>
<ProductNDC>0363-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablets 500 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211013</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WALGREENS</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves minor aches and pains due to: : 1 headache, 2 the common cold, 3 backache, 4 minor pain of arthritis, 5 toothache, 6 muscular aches, 7 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-669-44</NDCCode>
<PackageDescription>4 CARTON in 1 PACKAGE (10237-669-44) / 1 TUBE in 1 CARTON / 127 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0669-44</NDC11Code>
<ProductNDC>10237-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensitive Teeth And Gums</ProprietaryName>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20171016</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; POTASSIUM NITRATE</SubstanceName>
<StrengthNumber>2.43; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use : 1 aids in the prevention of dental decay, 2 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10967-669-17</NDCCode>
<PackageDescription>49 g in 1 JAR (10967-669-17) </PackageDescription>
<NDC11Code>10967-0669-17</NDC11Code>
<ProductNDC>10967-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ceramide Premiere Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, Octocrylene, Avobenzone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>REVLON</LabelerName>
<SubstanceName>OXYBENZONE; OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE</SubstanceName>
<StrengthNumber>4; 7.5; 3; 2; 5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-669-44</NDCCode>
<PackageDescription>257 g in 1 BOTTLE (11673-669-44) </PackageDescription>
<NDC11Code>11673-0669-44</NDC11Code>
<ProductNDC>11673-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Fiber Therapy</ProprietaryName>
<NonProprietaryName>Psyllium Husk</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>3.4</StrengthNumber>
<StrengthUnit>g/5.79g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-669-72</NDCCode>
<PackageDescription>425 g in 1 BOTTLE (11673-669-72) </PackageDescription>
<NDC11Code>11673-0669-72</NDC11Code>
<ProductNDC>11673-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Fiber Therapy</ProprietaryName>
<NonProprietaryName>Psyllium Husk</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>3.4</StrengthNumber>
<StrengthUnit>g/5.79g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-669-91</NDCCode>
<PackageDescription>660 g in 1 BOTTLE (11673-669-91) </PackageDescription>
<NDC11Code>11673-0669-91</NDC11Code>
<ProductNDC>11673-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Fiber Therapy</ProprietaryName>
<NonProprietaryName>Psyllium Husk</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>3.4</StrengthNumber>
<StrengthUnit>g/5.79g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25021-669-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-669-20) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0669-20</NDC11Code>
<ProductNDC>25021-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201836</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age , 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .</IndicationAndUsage>
<Description>Cisatracurium Besylate Injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R- [1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. : 1 The 5 mL single-dose vials contain 2 mg per mL cisatracurium, equivalent to 2.68 mg per mL cisatracurium besylate. , 2 The 10 mL multiple-dose vials contain 2 mg per mL cisatracurium, equivalent to 2.68 mg per mL cisatracurium besylate, and 0.9% benzyl alcohol as a preservative. , 3 The 20 mL single-dose vials contain 10 mg per mL cisatracurium, equivalent to 13.38 mg per mL cisatracurium besylate. .</Description>
</NDC>
<NDC>
<NDCCode>31722-669-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-669-60) </PackageDescription>
<NDC11Code>31722-0669-60</NDC11Code>
<ProductNDC>31722-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212788</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablets are available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as (±)N-(2,6-dimethylphenyl)-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperzin-1-yl]acetamide. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.55 g/mole, and the following structural formula:. Ranolazine is a white to off-white powder. Ranolazine is soluble in dichloromethane. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer (contains sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose, and sodium hydroxide. In addition, the film coating contains the following inactive ingredients: FD&C blue #1, FD&C blue #2, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>41250-669-96</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (41250-669-96) </PackageDescription>
<NDC11Code>41250-0669-96</NDC11Code>
<ProductNDC>41250-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meijer Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>Wintergreen Flavor</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-669-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10) </PackageDescription>
<NDC11Code>43063-0669-10</NDC11Code>
<ProductNDC>43063-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43063-669-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14) </PackageDescription>
<NDC11Code>43063-0669-14</NDC11Code>
<ProductNDC>43063-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43063-669-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20) </PackageDescription>
<NDC11Code>43063-0669-20</NDC11Code>
<ProductNDC>43063-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43063-669-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30) </PackageDescription>
<NDC11Code>43063-0669-30</NDC11Code>
<ProductNDC>43063-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43063-669-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60) </PackageDescription>
<NDC11Code>43063-0669-60</NDC11Code>
<ProductNDC>43063-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3) , 4 Ankylosing Spondylitis (AS) ( 1.4) , 5 Acute Pain (AP) ( 1.5) , 6 Primary Dysmenorrhea (PD) ( 1.6) .</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43406-0669-2</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (43406-0669-2) </PackageDescription>
<NDC11Code>43406-0669-02</NDC11Code>
<ProductNDC>43406-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Throat</ProprietaryName>
<NonProprietaryName>Baptisia, Phytolacca, Hydrastis, Apis Mel, Arg Nit, Belladonna, Hepar Sulph Calc, Kali Bic, Lac Can, Lachesis, Merc Solub</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180403</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS</SubstanceName>
<StrengthNumber>4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43742-0669-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0669-1)</PackageDescription>
<NDC11Code>43742-0669-01</NDC11Code>
<ProductNDC>43742-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circulation</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Kali Carbonicum, Kalmia Latifolia, Arnica Montana, Glonoinum, Ignatia Amara, Lacticum Acidum, Ranunculus Bulbosus, Alpha-ketoglutaricum Acidum, Arsenicum Album, Heart (suis), Fumaricum Acidum, Hepar Suis, Malic Acid, Natrum Oxalaceticum, Phosphorus, Strophanthus Hispidus, Spigelia Anthelmia, Carbo Vegetabilis, Naja Tripudians, Cytomegalovirus, Epstein-barr Virus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151119</StartMarketingDate>
<EndMarketingDate>20201217</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; ARNICA MONTANA; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACTIC ACID, DL-; RANUNCULUS BULBOSUS; OXOGLURIC ACID; ARSENIC TRIOXIDE; PORK HEART; FUMARIC ACID; PORK LIVER; MALIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS; STROPHANTHUS HISPIDUS SEED; SPIGELIA ANTHELMIA; ACTIVATED CHARCOAL; NAJA NAJA VENOM; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4</SubstanceName>
<StrengthNumber>3; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 12; 15; 17; 17</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>47335-669-13</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-13) </PackageDescription>
<NDC11Code>47335-0669-13</NDC11Code>
<ProductNDC>47335-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090421</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-14</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
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<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-19) </PackageDescription>
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<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
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<NDCCode>47335-669-81</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-81) </PackageDescription>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
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<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
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<NDCCode>47335-669-83</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-669-83) </PackageDescription>
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<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Chronic Stable Angina:Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,-3-dihydro-2(4-methoxyphenyl)-, mono-hydrochloride, (+)-cis. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP, for oral administration, contain diltiazem hydrochloride, USP in extended-release pellets at doses of 120, 180, 240, 300 and 360 mg. Diltiazem hydrochloride extended-release capsules also contain: Sugar Spheres NF, Hypromellose USP, Talc USP, Ethyl Cellulose NF, Triethyl Citrate NF. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate, FD & C Blue 1, FD & C Red 3 (120 mg, 240 mg, and 300 mg), FD & C Green 3 (180 mg, 240 mg, and 360 mg), and D & C Yellow 10 (180 mg, 240 mg, and 360 mg).Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. Meets USP dissolution test 25.</Description>
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