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"Description": "Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide."
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"IndicationAndUsage": "SymptomaticTrichomoniasis.Metronidazole tablets, USP are indicated for the treatment of T.vaginalisinfection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). AsymptomaticTrichomoniasis.Metronidazole tablets, USP are indicated in the treatment of asymptomatic T.vaginalisinfection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. TreatmentofAsymptomaticSexualPartners.T.vaginalisinfection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis.Metronidazole tablets, USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. AnaerobicBacterialInfections.Metronidazole tablets, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroidesspecies including the B.fragilisgroup ( B.fragilis, B.distasonis, B.ovatus, B.thetaiotaomicron, B.vulgatus), Clostridiumspecies, Eubacteriumspecies, Peptococcusspecies, and Peptostreptococcusspecies. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroidesspecies including the B.fragilisgroup, Clostridiumspecies, Peptococcusspecies, Peptostreptococcusspecies, and Fusobacteriumspecies. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroidesspecies including the B.fragilisgroup, Clostridiumspecies, Peptococcusspecies, Peptostreptococcusspecies, and Fusobacteriumspecies. BACTERIAL SEPTICEMIA caused by Bacteroidesspecies including the B.fragilisgroup and Clostridiumspecies. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroidesspecies including the B.fragilisgroup. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroidesspecies including the B.fragilisgroup. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroidesspecies including the B.fragilisgroup. ENDOCARDITIS caused by Bacteroidesspecies including the B.fragilisgroup. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide."
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{
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"Description": "Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide."
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{
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"LabelerName": "Sportpharm LLC",
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"Description": "Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide."
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{
"NDCCode": "11084-024-20",
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"ProductNDC": "11084-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Agrobac Pure Foam",
"NonProprietaryName": "Benzalkonium Chloride",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
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"IndicationAndUsage": "for hand washing to reduce bacteria on the skin."
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{
"NDCCode": "13668-024-20",
"PackageDescription": "2000 TABLET in 1 BOTTLE (13668-024-20) ",
"NDC11Code": "13668-0024-20",
"ProductNDC": "13668-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078573",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20090205",
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},
{
"NDCCode": "14445-024-07",
"PackageDescription": "20 kg in 1 DRUM (14445-024-07) ",
"NDC11Code": "14445-0024-07",
"ProductNDC": "14445-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-05-22",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "15-MAR-24"
},
{
"NDCCode": "26052-024-01",
"PackageDescription": "20 PACKET in 1 BAG (26052-024-01) > 3 g in 1 PACKET",
"NDC11Code": "26052-0024-01",
"ProductNDC": "26052-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Throat Drops Honey Lemon",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"EndMarketingDate": "20211021",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "BURT'S BEES",
"SubstanceName": "MENTHOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/3g",
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"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "42292-024-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42292-024-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-024-01) ",
"NDC11Code": "42292-0024-20",
"ProductNDC": "42292-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200651",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160823",
"SamplePackage": "N"
},
{
"NDCCode": "47621-024-04",
"PackageDescription": "20 kg in 1 DRUM (47621-024-04) ",
"NDC11Code": "47621-0024-04",
"ProductNDC": "47621-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Raks Pharma Pvt. Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-JAN-21"
},
{
"NDCCode": "48433-024-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (48433-024-20) / 1 TABLET in 1 BLISTER PACK (48433-024-01) ",
"NDC11Code": "48433-0024-20",
"ProductNDC": "48433-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075417",
"LabelerName": "Safecor Health LLC",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine tablets are an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. ( 1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior. ( 1.2) .",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-Chloro-11-(4-methyl-1-piperazinyl)-5 H-dibenzo [ b,e] [1,4] diazepine. The structural formula is:. Clozapine is available in peach tablets of 25 mg or green tablets of 50 mg, 100 mg or 200 mg for oral administration. Active Ingredient: clozapine. Inactive ingredients are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. In addition, the 25 mg tablets contain FD&C Red No. 40 Aluminum Lake, and the 50 mg, 100 mg and 200 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "49836-024-10",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (49836-024-10) * 20 mL in 1 VIAL * .55 mL in 1 POUCH",
"NDC11Code": "49836-0024-10",
"ProductNDC": "49836-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anesthesia S/i-60",
"NonProprietaryName": "Propofol, Sterile Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20170616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019627",
"LabelerName": "RX PHARMA-PACK, INC.",
"Status": "Deprecated",
"LastUpdate": "2020-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170616",
"SamplePackage": "N"
},
{
"NDCCode": "50632-024-02",
"PackageDescription": "20 VIAL in 1 CARTON (50632-024-02) / .5 mL in 1 VIAL (50632-024-04) ",
"NDC11Code": "50632-0024-02",
"ProductNDC": "50632-024",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Jynneos",
"NonProprietaryName": "Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125678",
"LabelerName": "Bavarian Nordic A/S",
"SubstanceName": "VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN",
"StrengthNumber": "50000000",
"StrengthUnit": "1/.5mL",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
},
{
"NDCCode": "51079-024-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) ",
"NDC11Code": "51079-0024-20",
"ProductNDC": "51079-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076698",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050201",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .",
"Description": "Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2."
},
{
"NDCCode": "55289-024-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-024-20)",
"NDC11Code": "55289-0024-20",
"ProductNDC": "55289-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062882",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMPICILLIN TRIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-06-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59767-024-00",
"PackageDescription": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-00) ",
"NDC11Code": "59767-0024-00",
"ProductNDC": "59767-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pertzye",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170713",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA022175",
"LabelerName": "Digestive Care, Inc.",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "24000; 90750; 86250",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170713",
"SamplePackage": "Y",
"IndicationAndUsage": "PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows. 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase; delayed-release capsules have a clear body printed in green with \"4\" and a clear cap printed with a green circular stripe and \"DCI\". The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase; delayed-release capsules have a clear body printed in blue with \"8\" and a clear cap printed with a blue circular stripe and \"DCI\". The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase; delayed-release capsules have a clear body printed in red with \"16\" and a clear cap printed with a red circular stripe and \"DCI\". The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac. 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with \"24\" and a clear cap printed with a purple circular stripe and \"DCI\". The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol."
},
{
"NDCCode": "63189-024-20",
"PackageDescription": "1 BAG in 1 DRUM (63189-024-20) / 121212 TABLET in 1 BAG",
"NDC11Code": "63189-0024-20",
"ProductNDC": "63189-024",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET",
"StartMarketingDate": "20260101",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "AMOL PHARMACEUTICALS PRIVATE LIMITED",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-JAN-26",
"EndMarketingDatePackage": "30-SEP-26"
},
{
"NDCCode": "64406-024-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (64406-024-01) / 20 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "64406-0024-01",
"ProductNDC": "64406-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofidence",
"NonProprietaryName": "Tocilizumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240501",
"EndMarketingDate": "20270801",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761354",
"LabelerName": "Biogen MA Inc",
"SubstanceName": "TOCILIZUMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240501",
"EndMarketingDatePackage": "20270801",
"SamplePackage": "N",
"IndicationAndUsage": "TOFIDENCE (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) ( 1.1) : 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).",
"Description": "Tocilizumab-bavi is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H 2L 2polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-bavi has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells."
},
{
"NDCCode": "64950-024-20",
"PackageDescription": "20 PACKET in 1 CARTON (64950-024-20) > 4 mL in 1 PACKET",
"NDC11Code": "64950-0024-20",
"ProductNDC": "64950-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Delsan",
"ProprietaryNameSuffix": "Lavender",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210501",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Genus Lifesciences Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210501",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "67544-024-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (67544-024-20)",
"NDC11Code": "67544-0024-20",
"ProductNDC": "67544-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040201",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67544-024-26",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (67544-024-26)",
"NDC11Code": "67544-0024-26",
"ProductNDC": "67544-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040201",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69766-024-04",
"PackageDescription": "20 kg in 1 DRUM (69766-024-04) ",
"NDC11Code": "69766-0024-04",
"ProductNDC": "69766-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Apremilast",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161223",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MSN Life Sciences Private Limited",
"SubstanceName": "APREMILAST",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-14",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "23-DEC-16"
},
{
"NDCCode": "69842-024-15",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (69842-024-15) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "69842-0024-15",
"ProductNDC": "69842-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"ProprietaryNameSuffix": "Coated Fruit",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079044",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "70605-024-20",
"PackageDescription": "60 mL in 1 BOTTLE (70605-024-20) ",
"NDC11Code": "70605-0024-20",
"ProductNDC": "70605-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sheer Cover Nourishing Moisturizer",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octinoxate, Octisalate, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "7.5; 5; 3",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160531",
"SamplePackage": "N",
"IndicationAndUsage": "Use daily for best results. Smooth onto clean skin. Allow Nourishing Moisturizer to absorb completely before applying makeup. May be blended with your favorite Sheer Cover mineral foundation to create your own tinted moisturizer."
},
{
"NDCCode": "71288-024-21",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-024-21) / 15 mL in 1 VIAL, SINGLE-DOSE (71288-024-20) ",
"NDC11Code": "71288-0024-21",
"ProductNDC": "71288-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215195",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1) , 2 Infective Endocarditis (1.2) , 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4) , 5 Lower Respiratory Tract Infections (1.5) .",
"Description": "Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Injection, USP is a sterile white or off white to light tan colored lyophilized powder or cake for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg of vancomycin hydrochloride, USP equivalent to 750 mg of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless to light yellow or tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)]."
},
{
"NDCCode": "73069-024-51",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-024-51) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-51",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>85766-024-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (85766-024-20) </PackageDescription>
<NDC11Code>85766-0024-20</NDC11Code>
<ProductNDC>85766-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206560</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<Description>Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
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<Description>Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
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<Description>Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
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<Description>Metronidazole tablets, 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>51079-024-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) </PackageDescription>
<NDC11Code>51079-0024-20</NDC11Code>
<ProductNDC>51079-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076698</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .</IndicationAndUsage>
<Description>Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55289-024-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-024-20)</PackageDescription>
<NDC11Code>55289-0024-20</NDC11Code>
<ProductNDC>55289-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062882</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMPICILLIN TRIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59767-024-00</NDCCode>
<PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-00) </PackageDescription>
<NDC11Code>59767-0024-00</NDC11Code>
<ProductNDC>59767-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pertzye</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170713</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022175</ApplicationNumber>
<LabelerName>Digestive Care, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>24000; 90750; 86250</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170713</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows. 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase; delayed-release capsules have a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase; delayed-release capsules have a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase; delayed-release capsules have a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac. 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.</Description>
</NDC>
<NDC>
<NDCCode>63189-024-20</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (63189-024-20) / 121212 TABLET in 1 BAG</PackageDescription>
<NDC11Code>63189-0024-20</NDC11Code>
<ProductNDC>63189-024</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20260101</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>AMOL PHARMACEUTICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-JAN-26</StartMarketingDatePackage>
<EndMarketingDatePackage>30-SEP-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64406-024-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (64406-024-01) / 20 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>64406-0024-01</NDC11Code>
<ProductNDC>64406-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofidence</ProprietaryName>
<NonProprietaryName>Tocilizumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<EndMarketingDate>20270801</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761354</ApplicationNumber>
<LabelerName>Biogen MA Inc</LabelerName>
<SubstanceName>TOCILIZUMAB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<EndMarketingDatePackage>20270801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOFIDENCE (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of. Rheumatoid Arthritis (RA) ( 1.1) : 1 Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).</IndicationAndUsage>
<Description>Tocilizumab-bavi is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H 2L 2polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-bavi has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells.</Description>
</NDC>
<NDC>
<NDCCode>64950-024-20</NDCCode>
<PackageDescription>20 PACKET in 1 CARTON (64950-024-20) > 4 mL in 1 PACKET</PackageDescription>
<NDC11Code>64950-0024-20</NDC11Code>
<ProductNDC>64950-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Delsan</ProprietaryName>
<ProprietaryNameSuffix>Lavender</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Genus Lifesciences Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67544-024-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (67544-024-20)</PackageDescription>
<NDC11Code>67544-0024-20</NDC11Code>
<ProductNDC>67544-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040201</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67544-024-26</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (67544-024-26)</PackageDescription>
<NDC11Code>67544-0024-26</NDC11Code>
<ProductNDC>67544-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040201</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69766-024-04</NDCCode>
<PackageDescription>20 kg in 1 DRUM (69766-024-04) </PackageDescription>
<NDC11Code>69766-0024-04</NDC11Code>
<ProductNDC>69766-024</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Apremilast</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161223</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MSN Life Sciences Private Limited</LabelerName>
<SubstanceName>APREMILAST</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-14</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-DEC-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69842-024-15</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (69842-024-15) / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69842-0024-15</NDC11Code>
<ProductNDC>69842-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<ProprietaryNameSuffix>Coated Fruit</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079044</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70605-024-20</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (70605-024-20) </PackageDescription>
<NDC11Code>70605-0024-20</NDC11Code>
<ProductNDC>70605-024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sheer Cover Nourishing Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 5; 3</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use daily for best results. Smooth onto clean skin. Allow Nourishing Moisturizer to absorb completely before applying makeup. May be blended with your favorite Sheer Cover mineral foundation to create your own tinted moisturizer.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71288-024-21</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (71288-024-21) / 15 mL in 1 VIAL, SINGLE-DOSE (71288-024-20) </PackageDescription>
<NDC11Code>71288-0024-21</NDC11Code>
<ProductNDC>71288-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215195</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: : 1 Septicemia (1.1) , 2 Infective Endocarditis (1.2) , 3 Skin and Skin Structure Infections (1.3) , 4 Bone Infections (1.4) , 5 Lower Respiratory Tract Infections (1.5) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula. Vancomycin Hydrochloride for Injection, USP is a sterile white or off white to light tan colored lyophilized powder or cake for injection. Vancomycin Hydrochloride for Injection, USP is supplied in single-dose vials, containing 769 mg of vancomycin hydrochloride, USP equivalent to 750 mg of vancomycin base. The lyophilized powder is reconstituted with Sterile Water for Injection, USP which forms a clear, colorless to light yellow or tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
</NDC>
<NDC>
<NDCCode>73069-024-51</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-024-51) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-51</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>