{
"NDC": [
{
"NDCCode": "0074-3063-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3063-30)",
"NDC11Code": "00074-3063-30",
"ProductNDC": "0074-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0074-3063-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3063-90)",
"NDC11Code": "00074-3063-90",
"ProductNDC": "0074-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "36987-3063-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-3063-3)",
"NDC11Code": "36987-3063-03",
"ProductNDC": "36987-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Black Walnut",
"NonProprietaryName": "Black Walnut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUGLANS NIGRA POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "63629-3063-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (63629-3063-1) ",
"NDC11Code": "63629-3063-01",
"ProductNDC": "63629-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260407",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin Tablets, USP is gabapentin, USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24 g/mol. The structural formula of gabapentin, USP is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, opadry white, polyethylene glycol and talc. Additionally, the coating material opadry white contains hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "68071-3063-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-3063-3) ",
"NDC11Code": "68071-3063-03",
"ProductNDC": "68071-3063",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby",
"ProprietaryNameSuffix": "Meclizine Hcl, 12.5 Mg Each Antiemetic",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140307",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170310",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. prevents and treats nausea, vomiting or dizziness due to motion sickness."
},
{
"NDCCode": "70518-3063-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-0) ",
"NDC11Code": "70518-3063-00",
"ProductNDC": "70518-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076558",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210402",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated. Skin and Skin Structure Infections ( 1.1) Bone and Joint Infections ( 1.2) Complicated Intra-Abdominal Infections ( 1.3) Infectious Diarrhea ( 1.4) Typhoid Fever (Enteric Fever) ( 1.5) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) Plague in adult and pediatric patients ( 1.8) Chronic Bacterial Prostatitis ( 1.9) Lower Respiratory Tract Infections ( 1.10) o Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11) o Urinary Tract Infections (UTI) o Acute Uncomplicated Cystitis o Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).",
"Description": "Ciprofloxacin tablets, USP (ciprofloxacin hydrochloride) are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "70518-3063-6",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6) ",
"NDC11Code": "70518-3063-06",
"ProductNDC": "70518-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076558",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220804",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .",
"Description": "Ciprofloxacin tablets, USP (ciprofloxacin hydrochloride) are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "71335-3063-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-3063-1) ",
"NDC11Code": "71335-3063-01",
"ProductNDC": "71335-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215599",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, Flecainide Acetate Tablets, USP are indicated for the prevention of. : 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate USP for oral administration. Flecainide acetate USP is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate USP is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide Acetate Tablets, USP also contain: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Flecainide Acetate Tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "0228-3063-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3063-11) ",
"NDC11Code": "00228-3063-11",
"ProductNDC": "0228-3063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077302",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120622",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients and colors in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules include: ammonio methacrylate copolymer NF, type A and type B, hydroxypropyl cellulose, sucrose, corn starch, talc, and triethyl citrate. The 5 mg capsule shell contains: FD&C Blue #1, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 10 mg capsule shell contains: D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 15 mg capsule shell contains: D&C Yellow #10, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 20 mg capsule shell contains: FD&C Blue #1, gelatin, and titanium dioxide. The 25 mg capsule shell contains: D&C Yellow #10, gelatin, and titanium dioxide. The 30 mg capsule shell contains: gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or S-1-8115 black contains: D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, pharmaceutical glaze, synthetic black iron oxide, and may contain propylene glycol."
},
{
"NDCCode": "62206-3063-1",
"PackageDescription": "1 TUBE in 1 BOX (62206-3063-1) / 50 mL in 1 TUBE",
"NDC11Code": "62206-3063-01",
"ProductNDC": "62206-3063",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Badger Spf 30 Face Mineral Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240408",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "W.S. Badger Company, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "18.75",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"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 aging caused by the sun. ."
},
{
"NDCCode": "0074-0541-30",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0074-0541-30) > 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00074-0541-30",
"ProductNDC": "0074-0541",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gengraf",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"EndMarketingDate": "20180427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065003",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160620",
"EndMarketingDatePackage": "20180427",
"SamplePackage": "N"
},
{
"NDCCode": "0074-0576-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0074-0576-30) / 28 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00074-0576-30",
"ProductNDC": "0074-0576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venclexta",
"NonProprietaryName": "Venetoclax",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208573",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "VENETOCLAX",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .",
"Description": "Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side."
},
{
"NDCCode": "0074-1052-05",
"PackageDescription": "1 KIT in 1 CARTON (0074-1052-05) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET * 30 TABLET in 1 BOTTLE",
"NDC11Code": "00074-1052-05",
"ProductNDC": "0074-1052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupaneta Pack",
"NonProprietaryName": "Leuprolide Acetate And Norethindrone Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203696",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130701",
"SamplePackage": "N"
},
{
"NDCCode": "0074-1052-10",
"PackageDescription": "1 KIT in 1 CARTON (0074-1052-10) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET * 30 TABLET in 1 BOTTLE",
"NDC11Code": "00074-1052-10",
"ProductNDC": "0074-1052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupaneta Pack",
"NonProprietaryName": "Leuprolide Acetate And Norethindrone Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203696",
"LabelerName": "AbbVie Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130701",
"SamplePackage": "N"
},
{
"NDCCode": "0074-2306-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-30) ",
"NDC11Code": "00074-2306-30",
"ProductNDC": "0074-2306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rinvoq",
"NonProprietaryName": "Upadacitinib",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211675",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "UPADACITINIB",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N",
"IndicationAndUsage": "RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. : 1 RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.1)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.1), 2 RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.2)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.2), 3 RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. (1.3)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. (1.3), 4 RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.4)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.4) , 5 RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.5)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.5), 6 RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. (1.6)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.6) , 7 RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. (1.7)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.7), 8 RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.8)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.8), 9 RINVOQ is indicated for the treatment of adults with giant cell arteritis (1.9)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.9).",
"Description": "RINVOQ and RINVOQ LQ are formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1). The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37 oC. Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O ½ H2O. The chemical structure of upadacitinib is:. RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 30 mg extended-release tablets for oral administration are red, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a30’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 45 mg extended-release tablets for oral administration are yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a45’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ LQ oral solution for oral administration is a 1 mg/mL clear, colorless to light yellow solution. Each 1 mL RINVOQ LQ contains 1 mg of upadacitinib as free base (equivalent to 1.02 mg upadacitinib hemihydrate) and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose."
},
{
"NDCCode": "0074-2310-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2310-30) ",
"NDC11Code": "00074-2310-30",
"ProductNDC": "0074-2310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rinvoq",
"NonProprietaryName": "Upadacitinib",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211675",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "UPADACITINIB",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N",
"IndicationAndUsage": "RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. : 1 RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.1)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.1), 2 RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.2)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.2), 3 RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. (1.3)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. (1.3), 4 RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.4)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.4) , 5 RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.5)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.5), 6 RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. (1.6)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.6) , 7 RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. (1.7)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.7), 8 RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.8)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.8), 9 RINVOQ is indicated for the treatment of adults with giant cell arteritis (1.9)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.9).",
"Description": "RINVOQ and RINVOQ LQ are formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1). The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37 oC. Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O ½ H2O. The chemical structure of upadacitinib is:. RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 30 mg extended-release tablets for oral administration are red, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a30’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 45 mg extended-release tablets for oral administration are yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a45’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ LQ oral solution for oral administration is a 1 mg/mL clear, colorless to light yellow solution. Each 1 mL RINVOQ LQ contains 1 mg of upadacitinib as free base (equivalent to 1.02 mg upadacitinib hemihydrate) and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose."
},
{
"NDCCode": "0074-2340-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0074-2340-30) ",
"NDC11Code": "00074-2340-30",
"ProductNDC": "0074-2340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norvir",
"NonProprietaryName": "Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022417",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "RITONAVIR",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "NORVIR tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection.",
"Description": "NORVIR (ritonavir) is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV). Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12- tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir has the following structural formula:. Ritonavir is a white-to-light-tan powder. Ritonavir has a bitter metallic taste. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. NORVIR tablets are available for oral administration in a strength of 100 mg ritonavir with the following inactive ingredients: copovidone, anhydrous dibasic calcium phosphate, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The following are the ingredients in the film coating: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, polyethylene glycol 3350, colloidal silicon dioxide, and polysorbate 80. NORVIR oral powder is beige/pale yellow to yellow and is available for oral administration as a packet containing 100 mg of ritonavir with the following inactive ingredients: copovidone, sorbitan monolaurate, and colloidal silicon dioxide."
},
{
"NDCCode": "0074-2456-11",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0074-2456-11)",
"NDC11Code": "00074-2456-11",
"ProductNDC": "0074-2456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2456-12",
"PackageDescription": "3 CARTON in 1 CARTON (0074-2456-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00074-2456-12",
"ProductNDC": "0074-2456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2457-11",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0074-2457-11)",
"NDC11Code": "00074-2457-11",
"ProductNDC": "0074-2457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2457-12",
"PackageDescription": "3 CARTON in 1 CARTON (0074-2457-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00074-2457-12",
"ProductNDC": "0074-2457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2457-71",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0074-2457-71)",
"NDC11Code": "00074-2457-71",
"ProductNDC": "0074-2457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2458-11",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0074-2458-11)",
"NDC11Code": "00074-2458-11",
"ProductNDC": "0074-2458",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2458-12",
"PackageDescription": "3 CARTON in 1 CARTON (0074-2458-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00074-2458-12",
"ProductNDC": "0074-2458",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-2458-71",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0074-2458-71)",
"NDC11Code": "00074-2458-71",
"ProductNDC": "0074-2458",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meridia",
"NonProprietaryName": "Sibutramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020632",
"LabelerName": "Abbott Laboratories",
"SubstanceName": "SIBUTRAMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-06-11"
},
{
"NDCCode": "0074-3023-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3023-30)",
"NDC11Code": "00074-3023-30",
"ProductNDC": "0074-3023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "K-tab",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19800609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018279",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "0074-3045-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3045-30)",
"NDC11Code": "00074-3045-30",
"ProductNDC": "0074-3045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0074-3058-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3058-30)",
"NDC11Code": "00074-3058-30",
"ProductNDC": "0074-3058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "K-tab",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19800609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018279",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "0074-3061-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3061-30)",
"NDC11Code": "00074-3061-30",
"ProductNDC": "0074-3061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-09-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0074-3062-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3062-30)",
"NDC11Code": "00074-3062-30",
"ProductNDC": "0074-3062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-08-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>0074-3063-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3063-30)</PackageDescription>
<NDC11Code>00074-3063-30</NDC11Code>
<ProductNDC>0074-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0074-3063-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3063-90)</PackageDescription>
<NDC11Code>00074-3063-90</NDC11Code>
<ProductNDC>0074-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36987-3063-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3063-3)</PackageDescription>
<NDC11Code>36987-3063-03</NDC11Code>
<ProductNDC>36987-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Black Walnut</ProprietaryName>
<NonProprietaryName>Black Walnut</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS NIGRA POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>63629-3063-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (63629-3063-1) </PackageDescription>
<NDC11Code>63629-3063-01</NDC11Code>
<ProductNDC>63629-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin Tablets, USP is gabapentin, USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C9H17NO2 and the molecular weight is 171.24 g/mol. The structural formula of gabapentin, USP is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, opadry white, polyethylene glycol and talc. Additionally, the coating material opadry white contains hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-3063-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-3063-3) </PackageDescription>
<NDC11Code>68071-3063-03</NDC11Code>
<ProductNDC>68071-3063</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby</ProprietaryName>
<ProprietaryNameSuffix>Meclizine Hcl, 12.5 Mg Each Antiemetic</ProprietaryNameSuffix>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140307</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. prevents and treats nausea, vomiting or dizziness due to motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-3063-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-0) </PackageDescription>
<NDC11Code>70518-3063-00</NDC11Code>
<ProductNDC>70518-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076558</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated. Skin and Skin Structure Infections ( 1.1) Bone and Joint Infections ( 1.2) Complicated Intra-Abdominal Infections ( 1.3) Infectious Diarrhea ( 1.4) Typhoid Fever (Enteric Fever) ( 1.5) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) Plague in adult and pediatric patients ( 1.8) Chronic Bacterial Prostatitis ( 1.9) Lower Respiratory Tract Infections ( 1.10) o Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11) o Urinary Tract Infections (UTI) o Acute Uncomplicated Cystitis o Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP (ciprofloxacin hydrochloride) are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-3063-6</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6) </PackageDescription>
<NDC11Code>70518-3063-06</NDC11Code>
<ProductNDC>70518-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076558</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections ( 1.11) Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP (ciprofloxacin hydrochloride) are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-3063-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-3063-1) </PackageDescription>
<NDC11Code>71335-3063-01</NDC11Code>
<ProductNDC>71335-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215599</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, Flecainide Acetate Tablets, USP are indicated for the prevention of. : 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate USP for oral administration. Flecainide acetate USP is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate USP is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide Acetate Tablets, USP also contain: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Flecainide Acetate Tablets, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0228-3063-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3063-11) </PackageDescription>
<NDC11Code>00228-3063-11</NDC11Code>
<ProductNDC>0228-3063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077302</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients and colors in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules include: ammonio methacrylate copolymer NF, type A and type B, hydroxypropyl cellulose, sucrose, corn starch, talc, and triethyl citrate. The 5 mg capsule shell contains: FD&C Blue #1, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 10 mg capsule shell contains: D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 15 mg capsule shell contains: D&C Yellow #10, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 20 mg capsule shell contains: FD&C Blue #1, gelatin, and titanium dioxide. The 25 mg capsule shell contains: D&C Yellow #10, gelatin, and titanium dioxide. The 30 mg capsule shell contains: gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or S-1-8115 black contains: D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, pharmaceutical glaze, synthetic black iron oxide, and may contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>62206-3063-1</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (62206-3063-1) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>62206-3063-01</NDC11Code>
<ProductNDC>62206-3063</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Badger Spf 30 Face Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>W.S. Badger Company, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>18.75</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</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 aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-0541-30</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0074-0541-30) > 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-0541-30</NDC11Code>
<ProductNDC>0074-0541</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gengraf</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<EndMarketingDate>20180427</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065003</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<EndMarketingDatePackage>20180427</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-0576-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0074-0576-30) / 28 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-0576-30</NDC11Code>
<ProductNDC>0074-0576</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venclexta</ProprietaryName>
<NonProprietaryName>Venetoclax</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208573</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>VENETOCLAX</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VENCLEXTA is a BCL-2 inhibitor indicated: : 1 For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1) , 2 In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (1.2) .</IndicationAndUsage>
<Description>Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) and has the following chemical structure:. Venetoclax has very low aqueous solubility. VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10 mg, 50 mg, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.</Description>
</NDC>
<NDC>
<NDCCode>0074-1052-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-1052-05) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET * 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-1052-05</NDC11Code>
<ProductNDC>0074-1052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupaneta Pack</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203696</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-1052-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-1052-10) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET * 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-1052-10</NDC11Code>
<ProductNDC>0074-1052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupaneta Pack</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203696</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-2306-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-30) </PackageDescription>
<NDC11Code>00074-2306-30</NDC11Code>
<ProductNDC>0074-2306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rinvoq</ProprietaryName>
<NonProprietaryName>Upadacitinib</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211675</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>UPADACITINIB</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. : 1 RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.1)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.1), 2 RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.2)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.2), 3 RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. (1.3)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. (1.3), 4 RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.4)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.4) , 5 RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.5)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.5), 6 RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. (1.6)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.6) , 7 RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. (1.7)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.7), 8 RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.8)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.8), 9 RINVOQ is indicated for the treatment of adults with giant cell arteritis (1.9)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.9).</IndicationAndUsage>
<Description>RINVOQ and RINVOQ LQ are formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1). The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37 oC. Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O ½ H2O. The chemical structure of upadacitinib is:. RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 30 mg extended-release tablets for oral administration are red, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a30’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 45 mg extended-release tablets for oral administration are yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a45’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ LQ oral solution for oral administration is a 1 mg/mL clear, colorless to light yellow solution. Each 1 mL RINVOQ LQ contains 1 mg of upadacitinib as free base (equivalent to 1.02 mg upadacitinib hemihydrate) and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>0074-2310-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2310-30) </PackageDescription>
<NDC11Code>00074-2310-30</NDC11Code>
<ProductNDC>0074-2310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rinvoq</ProprietaryName>
<NonProprietaryName>Upadacitinib</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211675</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>UPADACITINIB</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. : 1 RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.1)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.1), 2 RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.2)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.2), 3 RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. (1.3)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. (1.3), 4 RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.4)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.4) , 5 RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. (1.5)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.5), 6 RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. (1.6)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.6) , 7 RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. (1.7)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.7), 8 RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.8)Limitations of UseRINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.8), 9 RINVOQ is indicated for the treatment of adults with giant cell arteritis (1.9)Limitations of UseRINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.9).</IndicationAndUsage>
<Description>RINVOQ and RINVOQ LQ are formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1). The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37 oC. Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O ½ H2O. The chemical structure of upadacitinib is:. RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 30 mg extended-release tablets for oral administration are red, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a30’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ 45 mg extended-release tablets for oral administration are yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a45’ on one side. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. RINVOQ LQ oral solution for oral administration is a 1 mg/mL clear, colorless to light yellow solution. Each 1 mL RINVOQ LQ contains 1 mg of upadacitinib as free base (equivalent to 1.02 mg upadacitinib hemihydrate) and the following inactive ingredients: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>0074-2340-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0074-2340-30) </PackageDescription>
<NDC11Code>00074-2340-30</NDC11Code>
<ProductNDC>0074-2340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norvir</ProprietaryName>
<NonProprietaryName>Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022417</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>RITONAVIR</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NORVIR tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection.</IndicationAndUsage>
<Description>NORVIR (ritonavir) is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV). Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12- tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir has the following structural formula:. Ritonavir is a white-to-light-tan powder. Ritonavir has a bitter metallic taste. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. NORVIR tablets are available for oral administration in a strength of 100 mg ritonavir with the following inactive ingredients: copovidone, anhydrous dibasic calcium phosphate, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The following are the ingredients in the film coating: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, polyethylene glycol 3350, colloidal silicon dioxide, and polysorbate 80. NORVIR oral powder is beige/pale yellow to yellow and is available for oral administration as a packet containing 100 mg of ritonavir with the following inactive ingredients: copovidone, sorbitan monolaurate, and colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0074-2456-11</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0074-2456-11)</PackageDescription>
<NDC11Code>00074-2456-11</NDC11Code>
<ProductNDC>0074-2456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2456-12</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (0074-2456-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-2456-12</NDC11Code>
<ProductNDC>0074-2456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2457-11</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0074-2457-11)</PackageDescription>
<NDC11Code>00074-2457-11</NDC11Code>
<ProductNDC>0074-2457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2457-12</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (0074-2457-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-2457-12</NDC11Code>
<ProductNDC>0074-2457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2457-71</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0074-2457-71)</PackageDescription>
<NDC11Code>00074-2457-71</NDC11Code>
<ProductNDC>0074-2457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2458-11</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0074-2458-11)</PackageDescription>
<NDC11Code>00074-2458-11</NDC11Code>
<ProductNDC>0074-2458</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2458-12</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (0074-2458-12) > 1 BOTTLE in 1 CARTON > 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>00074-2458-12</NDC11Code>
<ProductNDC>0074-2458</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-2458-71</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0074-2458-71)</PackageDescription>
<NDC11Code>00074-2458-71</NDC11Code>
<ProductNDC>0074-2458</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meridia</ProprietaryName>
<NonProprietaryName>Sibutramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020632</ApplicationNumber>
<LabelerName>Abbott Laboratories</LabelerName>
<SubstanceName>SIBUTRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Dopamine Uptake Inhibitors [MoA],Norepinephrine Uptake Inhibitors [MoA],Norepinephrine, Serotonin, and Dopamine Reuptake Inhibitor Anorectic [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-06-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-3023-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3023-30)</PackageDescription>
<NDC11Code>00074-3023-30</NDC11Code>
<ProductNDC>0074-3023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>K-tab</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19800609</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018279</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-3045-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3045-30)</PackageDescription>
<NDC11Code>00074-3045-30</NDC11Code>
<ProductNDC>0074-3045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0074-3058-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3058-30)</PackageDescription>
<NDC11Code>00074-3058-30</NDC11Code>
<ProductNDC>0074-3058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>K-tab</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19800609</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018279</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>0074-3061-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3061-30)</PackageDescription>
<NDC11Code>00074-3061-30</NDC11Code>
<ProductNDC>0074-3061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0074-3062-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3062-30)</PackageDescription>
<NDC11Code>00074-3062-30</NDC11Code>
<ProductNDC>0074-3062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-08-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>