{
"NDC": [
{
"NDCCode": "0074-3080-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3080-30) ",
"NDC11Code": "00074-3080-30",
"ProductNDC": "0074-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19970728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19970728",
"SamplePackage": "N"
},
{
"NDCCode": "0074-3080-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3080-90) ",
"NDC11Code": "00074-3080-90",
"ProductNDC": "0074-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19970728",
"EndMarketingDate": "20181209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970728",
"EndMarketingDatePackage": "20181209",
"SamplePackage": "N"
},
{
"NDCCode": "0069-3080-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-3080-30) ",
"NDC11Code": "00069-3080-30",
"ProductNDC": "0069-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050730",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19960612",
"SamplePackage": "N"
},
{
"NDCCode": "36987-3080-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-3080-3)",
"NDC11Code": "36987-3080-03",
"ProductNDC": "36987-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "English Walnut",
"NonProprietaryName": "English Walnut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUGLANS REGIA 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": "53002-3080-5",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-3080-5) ",
"NDC11Code": "53002-3080-05",
"ProductNDC": "53002-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "59762-3080-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59762-3080-1) ",
"NDC11Code": "59762-3080-01",
"ProductNDC": "59762-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050730",
"LabelerName": "Greenstone LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19960612",
"SamplePackage": "N"
},
{
"NDCCode": "68071-3080-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68071-3080-3) ",
"NDC11Code": "68071-3080-03",
"ProductNDC": "68071-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201407",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TRIAMTERENE",
"StrengthNumber": "25; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170314",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.",
"Description": "Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1, 2, 4-benzothiadiazine-7- sulfonamide 1,1-dioxide, and its structural formula is:. Molecular Formula: C 7H 8CIN 3O 4S 2 M.W. 297.74. At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2, 4, 7-triamino-6-phenylpteridine and its structural formula is. Molecular Formula: C 12H 11N 7 M.W. 253.26. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for triamterene and hydrochlorothiazide capsules."
},
{
"NDCCode": "70518-3080-1",
"PackageDescription": "30 POUCH in 1 BOX (70518-3080-1) > 1 TABLET in 1 POUCH (70518-3080-2) ",
"NDC11Code": "70518-3080-01",
"ProductNDC": "70518-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biktarvy",
"NonProprietaryName": "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210251",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"StrengthNumber": "50; 200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210714",
"SamplePackage": "N"
},
{
"NDCCode": "70518-3080-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-3080-3) ",
"NDC11Code": "70518-3080-03",
"ProductNDC": "70518-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biktarvy",
"NonProprietaryName": "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210251",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"StrengthNumber": "50; 200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230510",
"SamplePackage": "N",
"IndicationAndUsage": "BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in: 1 adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history orto replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4), and Use in Specific Populations (8.1)]. .",
"Description": "BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. : 1 BIC is an integrase strand transfer inhibitor (INSTI)., 2 FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)., 3 TAF, an HIV NRTI, is converted in vivoto tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. ."
},
{
"NDCCode": "71335-3080-3",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-3) ",
"NDC11Code": "71335-3080-03",
"ProductNDC": "71335-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078761",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations[see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tabletsare not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist.Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide.The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).The 15 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400The 60 mg tablets also contain: FD&C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400The 100 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400The 200 mg tablets also contain: D&C Yellow # 10 aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400. Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "10742-3080-1",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10742-3080-1) / 4.2 g in 1 TUBE",
"NDC11Code": "10742-3080-01",
"ProductNDC": "10742-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mentholatum Natural Ice Protect Plus Spf 30",
"ProprietaryNameSuffix": "Protect Plus Spf 30",
"NonProprietaryName": "Avobenzone, Dimethicone, Octinoxate, Octisalate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Mentholatum Company",
"SubstanceName": "OCTINOXATE; OCTISALATE; AVOBENZONE; DIMETHICONE",
"StrengthNumber": "75; 50; 30; 10",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather."
},
{
"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"
}
]
}
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<NDCList>
<NDC>
<NDCCode>0074-3080-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3080-30) </PackageDescription>
<NDC11Code>00074-3080-30</NDC11Code>
<ProductNDC>0074-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-3080-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3080-90) </PackageDescription>
<NDC11Code>00074-3080-90</NDC11Code>
<ProductNDC>0074-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970728</StartMarketingDate>
<EndMarketingDate>20181209</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970728</StartMarketingDatePackage>
<EndMarketingDatePackage>20181209</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0069-3080-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-3080-30) </PackageDescription>
<NDC11Code>00069-3080-30</NDC11Code>
<ProductNDC>0069-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050730</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-3080-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3080-3)</PackageDescription>
<NDC11Code>36987-3080-03</NDC11Code>
<ProductNDC>36987-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>English Walnut</ProprietaryName>
<NonProprietaryName>English 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 REGIA 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>53002-3080-5</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-3080-5) </PackageDescription>
<NDC11Code>53002-3080-05</NDC11Code>
<ProductNDC>53002-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>59762-3080-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59762-3080-1) </PackageDescription>
<NDC11Code>59762-3080-01</NDC11Code>
<ProductNDC>59762-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050730</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-3080-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68071-3080-3) </PackageDescription>
<NDC11Code>68071-3080-03</NDC11Code>
<ProductNDC>68071-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201407</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TRIAMTERENE</SubstanceName>
<StrengthNumber>25; 37.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
<Description>Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1, 2, 4-benzothiadiazine-7- sulfonamide 1,1-dioxide, and its structural formula is:. Molecular Formula: C 7H 8CIN 3O 4S 2 M.W. 297.74. At 50°C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2, 4, 7-triamino-6-phenylpteridine and its structural formula is. Molecular Formula: C 12H 11N 7 M.W. 253.26. Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for triamterene and hydrochlorothiazide capsules.</Description>
</NDC>
<NDC>
<NDCCode>70518-3080-1</NDCCode>
<PackageDescription>30 POUCH in 1 BOX (70518-3080-1) > 1 TABLET in 1 POUCH (70518-3080-2) </PackageDescription>
<NDC11Code>70518-3080-01</NDC11Code>
<ProductNDC>70518-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biktarvy</ProprietaryName>
<NonProprietaryName>Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210251</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE</SubstanceName>
<StrengthNumber>50; 200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70518-3080-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-3080-3) </PackageDescription>
<NDC11Code>70518-3080-03</NDC11Code>
<ProductNDC>70518-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biktarvy</ProprietaryName>
<NonProprietaryName>Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210251</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE</SubstanceName>
<StrengthNumber>50; 200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in: 1 adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history orto replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4), and Use in Specific Populations (8.1)]. .</IndicationAndUsage>
<Description>BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. : 1 BIC is an integrase strand transfer inhibitor (INSTI)., 2 FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)., 3 TAF, an HIV NRTI, is converted in vivoto tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. .</Description>
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<NDCCode>71335-3080-3</NDCCode>
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<NDC11Code>71335-3080-03</NDC11Code>
<ProductNDC>71335-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078761</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
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<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations[see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tabletsare not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist.Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide.The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).The 15 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400The 60 mg tablets also contain: FD&C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400The 100 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400The 200 mg tablets also contain: D&C Yellow # 10 aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400. Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
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<NDC11Code>10742-3080-01</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mentholatum Natural Ice Protect Plus Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Protect Plus Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Dimethicone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Mentholatum Company</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; AVOBENZONE; DIMETHICONE</SubstanceName>
<StrengthNumber>75; 50; 30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather.</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>
</NDCList>