{
"NDC": [
{
"NDCCode": "62135-067-18",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (62135-067-18) ",
"NDC11Code": "62135-0067-18",
"ProductNDC": "62135-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840806",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018829",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4."
},
{
"NDCCode": "62135-067-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-067-90) ",
"NDC11Code": "62135-0067-90",
"ProductNDC": "62135-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840806",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018829",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4."
},
{
"NDCCode": "49252-067-18",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (49252-067-18) ",
"NDC11Code": "49252-0067-18",
"ProductNDC": "49252-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208659",
"LabelerName": "Inventia Healthcare Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200529",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablet is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of. antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only)."
},
{
"NDCCode": "71919-772-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) ",
"NDC11Code": "71919-0772-18",
"ProductNDC": "71919-772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "30c And 200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts."
},
{
"NDCCode": "71919-822-18",
"PackageDescription": "50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) ",
"NDC11Code": "71919-0822-18",
"ProductNDC": "71919-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "200c Homeopathic Remedy Kit",
"NonProprietaryName": "50 Remedy Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20240229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts."
},
{
"NDCCode": "62135-068-18",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (62135-068-18) ",
"NDC11Code": "62135-0068-18",
"ProductNDC": "62135-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070651",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1."
},
{
"NDCCode": "62135-141-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-141-18) ",
"NDC11Code": "62135-0141-18",
"ProductNDC": "62135-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081265",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "62135-142-18",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (62135-142-18) ",
"NDC11Code": "62135-0142-18",
"ProductNDC": "62135-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081265",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220307",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "62135-144-18",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (62135-144-18) ",
"NDC11Code": "62135-0144-18",
"ProductNDC": "62135-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081265",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220307",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "62135-176-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-176-18) ",
"NDC11Code": "62135-0176-18",
"ProductNDC": "62135-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaprozin",
"NonProprietaryName": "Oxaprozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075987",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "OXAPROZIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220822",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaprozin tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of juvenile rheumatoid arthritis.",
"Description": "Oxaprozin tablets, USP is a nonsteroidal anti-inflammatory drug (NSAID), chemically designated as 4,5-diphenyl-2-oxazole-propionic acid, and has the following chemical structure. The molecular formula for oxaprozin is C 18H 15NO 3, and the molecular weight is 293. Oxaprozin is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pK a in water is 4.3. Each tablet, for oral administration, contains 600 mg of oxaprozin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, , magnesium stearate, methylcellulose, polyethylene glycol, stearic acid and titanium dioxide."
},
{
"NDCCode": "62135-205-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-205-18) ",
"NDC11Code": "62135-0205-18",
"ProductNDC": "62135-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-206-18) ",
"NDC11Code": "62135-0206-18",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-321-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62135-321-18) ",
"NDC11Code": "62135-0321-18",
"ProductNDC": "62135-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methyldopa",
"NonProprietaryName": "Methyldopa",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840629",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018934",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHYLDOPA",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension.",
"Description": "Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol."
},
{
"NDCCode": "62135-322-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62135-322-18) ",
"NDC11Code": "62135-0322-18",
"ProductNDC": "62135-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methyldopa",
"NonProprietaryName": "Methyldopa",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840629",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018934",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHYLDOPA",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension.",
"Description": "Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol."
},
{
"NDCCode": "62135-470-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-470-18) ",
"NDC11Code": "62135-0470-18",
"ProductNDC": "62135-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211496",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230123",
"SamplePackage": "N",
"IndicationAndUsage": "Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement. In addition to the above indications, Prednisone Tablets, USP are indicated for systemic dermatomyositis (polymyositis).",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The formula for prednisone is C 21H 26O 5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure:. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water, slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone Tablets, USP contain 1 mg Prednisone, USP. The inactive ingredients for Prednisone Tablets, USP include: Microcrystalline Cellulose, Lactose Monohydrate, Pregelatinized Starch, Stearic Acid, Sodium Starch Glycolate and Magnesium Stearate."
},
{
"NDCCode": "62135-471-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-471-18) ",
"NDC11Code": "62135-0471-18",
"ProductNDC": "62135-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211495",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230123",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis. 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis. 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis. 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis. 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood. 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis. 12. Nervous System Acute exacerbations of multiple sclerosis. 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone Tablets, USP are available as 5 mg. Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), and stearic acid."
},
{
"NDCCode": "62135-680-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-680-18) ",
"NDC11Code": "62135-0680-18",
"ProductNDC": "62135-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-683-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-683-18) ",
"NDC11Code": "62135-0683-18",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-684-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-684-18) ",
"NDC11Code": "62135-0684-18",
"ProductNDC": "62135-684",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-715-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-715-18) ",
"NDC11Code": "62135-0715-18",
"ProductNDC": "62135-715",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077920",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"Description": "Meloxicam Tablets, USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg Meloxicam, USP for oral administration. Meloxicam, USP is chemically designated as 4-Hydroxy-2-methyl- N-(5-methylthiazol-2-yl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam, USP is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam, USP has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam, USP has pKa values of 1.1 and 4.2. Meloxicam, USP is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "62135-716-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-716-18) ",
"NDC11Code": "62135-0716-18",
"ProductNDC": "62135-716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077920",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"Description": "Meloxicam Tablets, USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg Meloxicam, USP for oral administration. Meloxicam, USP is chemically designated as 4-Hydroxy-2-methyl- N-(5-methylthiazol-2-yl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam, USP is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam, USP has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam, USP has pKa values of 1.1 and 4.2. Meloxicam, USP is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "62135-897-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-897-18) ",
"NDC11Code": "62135-0897-18",
"ProductNDC": "62135-897",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078060",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonneiwhen antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jiroveciipneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler's Diarrhea in Adults. For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim and in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients:Docusate sodium 85%, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate."
},
{
"NDCCode": "62135-898-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-898-18) ",
"NDC11Code": "62135-0898-18",
"ProductNDC": "62135-898",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078060",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonneiwhen antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jiroveciipneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler's Diarrhea in Adults. For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim and in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients:Docusate sodium 85%, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate."
},
{
"NDCCode": "62135-998-17",
"PackageDescription": "18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-998-17) ",
"NDC11Code": "62135-0998-17",
"ProductNDC": "62135-998",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078739",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260826",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. : 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.267 mg or 14.534 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: aspartame, calcium silicate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, silicified microcrystalline cellulose, and sweet orange flavor."
},
{
"NDCCode": "62135-999-17",
"PackageDescription": "18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-999-17) ",
"NDC11Code": "62135-0999-17",
"ProductNDC": "62135-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078739",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260826",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. : 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.",
"Description": "Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.267 mg or 14.534 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: aspartame, calcium silicate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, silicified microcrystalline cellulose, and sweet orange flavor."
},
{
"NDCCode": "11722-067-00",
"PackageDescription": "1 kg in 1 CARTON (11722-067-00) ",
"NDC11Code": "11722-0067-00",
"ProductNDC": "11722-067",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diroximel Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "TAPI Croatia Industries Ltd.",
"SubstanceName": "DIROXIMEL FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "22-MAY-18"
},
{
"NDCCode": "17156-067-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-10) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "17156-0067-10",
"ProductNDC": "17156-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vizamyl",
"NonProprietaryName": "Flutemetamol F-18",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203137",
"LabelerName": "Medi-Physics Inc.",
"SubstanceName": "FLUTEMETAMOL F-18",
"StrengthNumber": "4.05",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "17156-067-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "17156-0067-30",
"ProductNDC": "17156-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vizamyl",
"NonProprietaryName": "Flutemetamol F-18",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203137",
"LabelerName": "GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)",
"SubstanceName": "FLUTEMETAMOL F-18",
"StrengthNumber": "4.05",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140301",
"SamplePackage": "N",
"IndicationAndUsage": "VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline, 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.",
"Description": "VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C14H1118FN2OS, the molecular weight 273.32, and the following structural formula. VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution. Each mL contains up to 2 mcg of flutemetamol and 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time with the following inactive ingredients: 70 microL ethanol, 9 mg sodium chloride, and 4.98 mg polysorbate 80 (w/v) in 0.014 M aqueous phosphate buffer. The pH of the solution is between 6 and 8.5."
},
{
"NDCCode": "42291-067-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42291-067-30) ",
"NDC11Code": "42291-0067-30",
"ProductNDC": "42291-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079022",
"LabelerName": "AvKARE",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220412",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1).",
"Description": "Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "58930-067-04",
"PackageDescription": "5 BAG in 1 BOX (58930-067-04) > 30 g in 1 BAG (58930-067-03)",
"NDC11Code": "58930-0067-04",
"ProductNDC": "58930-067",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ahc Phyto Complex Mask",
"NonProprietaryName": "Adenosine 0.04%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161020",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Carver Korea Co.,Ltd",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "12",
"StrengthUnit": "mg/30g",
"Status": "Deprecated",
"LastUpdate": "2019-05-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4.</Description>
</NDC>
<NDC>
<NDCCode>62135-067-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-067-90) </PackageDescription>
<NDC11Code>62135-0067-90</NDC11Code>
<ProductNDC>62135-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840806</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018829</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4.</Description>
</NDC>
<NDC>
<NDCCode>49252-067-18</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (49252-067-18) </PackageDescription>
<NDC11Code>49252-0067-18</NDC11Code>
<ProductNDC>49252-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208659</ApplicationNumber>
<LabelerName>Inventia Healthcare Limited</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-20</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablet is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of. antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only).</Description>
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<NDCCode>71919-772-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-772-18) > 1 KIT in 1 VIAL, GLASS (71919-772-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-138-01) * 750 PELLET in 1 VIAL, GLASS (68428-080-01) * 750 PELLET in 1 VIAL, GLASS (68428-117-01) * 750 PELLET in 1 VIAL, GLASS (68428-097-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 750 PELLET in 1 VIAL, GLASS (68428-085-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-092-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-133-01) * 750 PELLET in 1 VIAL, GLASS (68428-124-01) * 750 PELLET in 1 VIAL, GLASS (68428-115-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 750 PELLET in 1 VIAL, GLASS (68428-095-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-147-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (68428-078-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-111-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-123-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 750 PELLET in 1 VIAL, GLASS (68428-142-01) * 750 PELLET in 1 VIAL, GLASS (68428-102-01) * 750 PELLET in 1 VIAL, GLASS (68428-122-01) * 750 PELLET in 1 VIAL, GLASS (68428-118-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 750 PELLET in 1 VIAL, GLASS (68428-146-01) * 750 PELLET in 1 VIAL, GLASS (68428-144-01) * 750 PELLET in 1 VIAL, GLASS (68428-125-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-156-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-082-01) * 750 PELLET in 1 VIAL, GLASS (68428-127-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-105-01) </PackageDescription>
<NDC11Code>71919-0772-18</NDC11Code>
<ProductNDC>71919-772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>30c And 200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. ACONITUM NAPELLUS Fear ALLIUM CEPA Head cold ANTIMONIUM TART Loose cough APIS MELLIFICA Stings ARGENTUM NITRICUM Impulsiveness ARNICA MONTANA Trauma ARSENICUM ALBUM Food poisoning BELLADONNA Fever BRYONIA ALBA Worse motion CALCAREA CARBONICA Overwork CALCAREA PHOSPHORICA Stiffness CALENDULA OFFICINALIS Wounds CANTHARIS Urinary tract CARBO VEGETABILIS Exhaustion CAULOPHYLLUM THAL Cramps CAUSTICUM Hoarseness CHAMOMILLA Irritability CINCHONA OFFICINALIS Debility COCCULUS INDICUS Motion sickness COFFEA CRUDA Sleeplessness COLOCYNTHIS Colic-like pain EUPHRASIA OFFICINALIS Eye irritation FERRUM PHOSPHORICUM Low fever GELSEMIUM SEMPERVIRENS Lethargy GLONOINUM Throbbing HEPAR SULPHURIS CALCAREUM Croupiness HYPERICUM PERFORATUM Shooting pain IGNATIA AMARA Sadness IPECACUANHA Nausea KALI BICHROMICUM Sinuses LACHESIS MUTUS Sore throat LEDUM PALUSTRE Black eyes LYCOPODIUM Digestion MAGNESIA PHOSPHORICA Cramps MERCURIUS VIVUS Sore throat NATRUM MURIATICUM Sneezing NUX VOMICA Vomiting PHOSPHORUS Hoarseness PHYTOLACCA Breast pain PULSATILLA Weeping PYROGENIUM Abscesses RHUS TOXICODENDRON Better motion RUTA GRAVEOLENS Bruised feeling SEPIA Indifference SILICEA Formation of pus SPONGIA TOSTA Wheezing STAPHYSAGRIA Anger SULFUR Skin problems SYMPHYTUM OFFICINALE Prickling pain THUJA OCCIDENTALIS Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-822-18</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 KIT (71919-822-18) / 1 KIT in 1 VIAL, GLASS (71919-822-01) * 350 PELLET in 1 VIAL, GLASS (71919-759-01) * 750 PELLET in 1 VIAL, GLASS (68428-074-01) * 750 PELLET in 1 VIAL, GLASS (68428-072-01) * 750 PELLET in 1 VIAL, GLASS (68428-069-01) * 750 PELLET in 1 VIAL, GLASS (68428-068-01) * 750 PELLET in 1 VIAL, GLASS (68428-067-01) * 750 PELLET in 1 VIAL, GLASS (68428-073-01) * 750 PELLET in 1 VIAL, GLASS (68428-065-01) * 350 PELLET in 1 VIAL, GLASS (71919-771-01) * 750 PELLET in 1 VIAL, GLASS (68428-064-01) * 750 PELLET in 1 VIAL, GLASS (71919-814-01) * 350 PELLET in 1 VIAL, GLASS (71919-770-01) * 750 PELLET in 1 VIAL, GLASS (68428-062-01) * 750 PELLET in 1 VIAL, GLASS (68428-061-01) * 750 PELLET in 1 VIAL, GLASS (68428-059-01) * 750 PELLET in 1 VIAL, GLASS (68428-058-01) * 750 PELLET in 1 VIAL, GLASS (68428-057-01) * 750 PELLET in 1 VIAL, GLASS (68428-056-01) * 350 PELLET in 1 VIAL, GLASS (71919-777-01) * 750 PELLET in 1 VIAL, GLASS (71919-813-01) * 350 PELLET in 1 VIAL, GLASS (71919-769-01) * 750 PELLET in 1 VIAL, GLASS (68428-055-01) * 750 PELLET in 1 VIAL, GLASS (68428-053-01) * 750 PELLET in 1 VIAL, GLASS (68428-054-01) * 750 PELLET in 1 VIAL, GLASS (68428-052-01) * 350 PELLET in 1 VIAL, GLASS (71919-763-01) * 750 PELLET in 1 VIAL, GLASS (68428-051-01) * 350 PELLET in 1 VIAL, GLASS (71919-760-01) * 750 PELLET in 1 VIAL, GLASS (68428-049-01) * 750 PELLET in 1 VIAL, GLASS (68428-048-01) * 750 PELLET in 1 VIAL, GLASS (68428-047-01) * 350 PELLET in 1 VIAL, GLASS (71919-766-01) * 350 PELLET in 1 VIAL, GLASS (71919-761-01) * 750 PELLET in 1 VIAL, GLASS (68428-045-01) * 350 PELLET in 1 VIAL, GLASS (71919-767-01) * 750 PELLET in 1 VIAL, GLASS (68428-042-01) * 750 PELLET in 1 VIAL, GLASS (68428-041-01) * 750 PELLET in 1 VIAL, GLASS (68428-036-01) * 750 PELLET in 1 VIAL, GLASS (68428-035-01) * 350 PELLET in 1 VIAL, GLASS (71919-762-01) * 350 PELLET in 1 VIAL, GLASS (71919-773-01) * 750 PELLET in 1 VIAL, GLASS (68428-034-01) * 750 PELLET in 1 VIAL, GLASS (68428-040-01) * 750 PELLET in 1 VIAL, GLASS (68428-033-01) * 750 PELLET in 1 VIAL, GLASS (68428-032-01) * 750 PELLET in 1 VIAL, GLASS (68428-030-01) * 750 PELLET in 1 VIAL, GLASS (71919-812-01) * 750 PELLET in 1 VIAL, GLASS (68428-028-01) * 750 PELLET in 1 VIAL, GLASS (68428-075-01) * 750 PELLET in 1 VIAL, GLASS (68428-026-01) </PackageDescription>
<NDC11Code>71919-0822-18</NDC11Code>
<ProductNDC>71919-822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>200c Homeopathic Remedy Kit</ProprietaryName>
<NonProprietaryName>50 Remedy Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240229</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acon nap fear. Aesculus hipp hemorrhoids. Allium cepa head cold. Antimon crud warts. Apis mel stings. Arnica bruises. Arsenicum alb vomiting. Belladonna fever. Bellis bruised soreness. Berber vulg itching. Bryonia worse motion. Calc carb overwork. Caulophyllum cramps. Causticum hoarseness. Chamomilla irritability. Cimicifuga minor back pain. Coffea cruda sleeplessness. Drosera cough. Eupatorium perf flu-like symptoms. Euphrasia eye irritation. Ferrum phos low fever. Gelsemium lethargy. Hamamelis varicose veins. Hepar sulph calc croupiness. Hydrastis sinuses. Hypericum shooting pain. Ignatia sadness. Ipecac nausea. Kali bic sinuses. Kali carb sour belching. Kali mur congested ears. Kali phos irritability. Lachesis sore throat. Ledum black eyes. Lycopodium digestion. Mag phos cramps. Nat mur sneezing. Nux vom vomiting. Petroleum nausea. Phosphoricum ac headache. Phytolacca sore throat. Podoph pelt diarrhea. Pulsatilla weeping. Rhus tox better motion. Ruta bruised feeling. Sepia indifference. Staphysag anger. Sulphur skin problems. Symphytum prickling pain. Thuja occ warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62135-068-18</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (62135-068-18) </PackageDescription>
<NDC11Code>62135-0068-18</NDC11Code>
<ProductNDC>62135-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070651</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>62135-141-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-141-18) </PackageDescription>
<NDC11Code>62135-0141-18</NDC11Code>
<ProductNDC>62135-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081265</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>62135-142-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (62135-142-18) </PackageDescription>
<NDC11Code>62135-0142-18</NDC11Code>
<ProductNDC>62135-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081265</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>62135-144-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (62135-144-18) </PackageDescription>
<NDC11Code>62135-0144-18</NDC11Code>
<ProductNDC>62135-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081265</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>62135-176-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-176-18) </PackageDescription>
<NDC11Code>62135-0176-18</NDC11Code>
<ProductNDC>62135-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaprozin</ProprietaryName>
<NonProprietaryName>Oxaprozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075987</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>OXAPROZIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaprozin tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For relief of the signs and symptoms of juvenile rheumatoid arthritis.</IndicationAndUsage>
<Description>Oxaprozin tablets, USP is a nonsteroidal anti-inflammatory drug (NSAID), chemically designated as 4,5-diphenyl-2-oxazole-propionic acid, and has the following chemical structure. The molecular formula for oxaprozin is C 18H 15NO 3, and the molecular weight is 293. Oxaprozin is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pK a in water is 4.3. Each tablet, for oral administration, contains 600 mg of oxaprozin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, , magnesium stearate, methylcellulose, polyethylene glycol, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-205-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-205-18) </PackageDescription>
<NDC11Code>62135-0205-18</NDC11Code>
<ProductNDC>62135-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-206-18) </PackageDescription>
<NDC11Code>62135-0206-18</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-321-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62135-321-18) </PackageDescription>
<NDC11Code>62135-0321-18</NDC11Code>
<ProductNDC>62135-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methyldopa</ProprietaryName>
<NonProprietaryName>Methyldopa</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840629</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018934</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHYLDOPA</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension.</IndicationAndUsage>
<Description>Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>62135-322-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62135-322-18) </PackageDescription>
<NDC11Code>62135-0322-18</NDC11Code>
<ProductNDC>62135-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methyldopa</ProprietaryName>
<NonProprietaryName>Methyldopa</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840629</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018934</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHYLDOPA</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension.</IndicationAndUsage>
<Description>Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>62135-470-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-470-18) </PackageDescription>
<NDC11Code>62135-0470-18</NDC11Code>
<ProductNDC>62135-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211496</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement. In addition to the above indications, Prednisone Tablets, USP are indicated for systemic dermatomyositis (polymyositis).</IndicationAndUsage>
<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The formula for prednisone is C 21H 26O 5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure:. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.43. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water, slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone Tablets, USP contain 1 mg Prednisone, USP. The inactive ingredients for Prednisone Tablets, USP include: Microcrystalline Cellulose, Lactose Monohydrate, Pregelatinized Starch, Stearic Acid, Sodium Starch Glycolate and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-471-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-471-18) </PackageDescription>
<NDC11Code>62135-0471-18</NDC11Code>
<ProductNDC>62135-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211495</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis. 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis. 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis. 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis. 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis. 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis. 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood. 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis. 12. Nervous System Acute exacerbations of multiple sclerosis. 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone Tablets, USP are available as 5 mg. Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-680-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-680-18) </PackageDescription>
<NDC11Code>62135-0680-18</NDC11Code>
<ProductNDC>62135-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-683-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-683-18) </PackageDescription>
<NDC11Code>62135-0683-18</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-684-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-684-18) </PackageDescription>
<NDC11Code>62135-0684-18</NDC11Code>
<ProductNDC>62135-684</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-715-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-715-18) </PackageDescription>
<NDC11Code>62135-0715-18</NDC11Code>
<ProductNDC>62135-715</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077920</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam Tablets, USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg Meloxicam, USP for oral administration. Meloxicam, USP is chemically designated as 4-Hydroxy-2-methyl- N-(5-methylthiazol-2-yl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam, USP is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam, USP has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam, USP has pKa values of 1.1 and 4.2. Meloxicam, USP is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>62135-716-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-716-18) </PackageDescription>
<NDC11Code>62135-0716-18</NDC11Code>
<ProductNDC>62135-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077920</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam Tablets, USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg Meloxicam, USP for oral administration. Meloxicam, USP is chemically designated as 4-Hydroxy-2-methyl- N-(5-methylthiazol-2-yl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam, USP is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam, USP has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam, USP has pKa values of 1.1 and 4.2. Meloxicam, USP is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>62135-897-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-897-18) </PackageDescription>
<NDC11Code>62135-0897-18</NDC11Code>
<ProductNDC>62135-897</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078060</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>400; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonneiwhen antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jiroveciipneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler's Diarrhea in Adults. For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim and in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients:Docusate sodium 85%, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>62135-898-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-898-18) </PackageDescription>
<NDC11Code>62135-0898-18</NDC11Code>
<ProductNDC>62135-898</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078060</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonneiwhen antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jiroveciipneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler's Diarrhea in Adults. For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim and in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients:Docusate sodium 85%, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>62135-998-17</NDCCode>
<PackageDescription>18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-998-17) </PackageDescription>
<NDC11Code>62135-0998-17</NDC11Code>
<ProductNDC>62135-998</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078739</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. : 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.267 mg or 14.534 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: aspartame, calcium silicate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, silicified microcrystalline cellulose, and sweet orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>62135-999-17</NDCCode>
<PackageDescription>18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-999-17) </PackageDescription>
<NDC11Code>62135-0999-17</NDC11Code>
<ProductNDC>62135-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078739</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. : 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its molecular formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.267 mg or 14.534 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: aspartame, calcium silicate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, silicified microcrystalline cellulose, and sweet orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>11722-067-00</NDCCode>
<PackageDescription>1 kg in 1 CARTON (11722-067-00) </PackageDescription>
<NDC11Code>11722-0067-00</NDC11Code>
<ProductNDC>11722-067</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Diroximel Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>TAPI Croatia Industries Ltd.</LabelerName>
<SubstanceName>DIROXIMEL FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-MAY-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17156-067-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-10) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>17156-0067-10</NDC11Code>
<ProductNDC>17156-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vizamyl</ProprietaryName>
<NonProprietaryName>Flutemetamol F-18</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203137</ApplicationNumber>
<LabelerName>Medi-Physics Inc.</LabelerName>
<SubstanceName>FLUTEMETAMOL F-18</SubstanceName>
<StrengthNumber>4.05</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17156-067-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>17156-0067-30</NDC11Code>
<ProductNDC>17156-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vizamyl</ProprietaryName>
<NonProprietaryName>Flutemetamol F-18</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203137</ApplicationNumber>
<LabelerName>GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)</LabelerName>
<SubstanceName>FLUTEMETAMOL F-18</SubstanceName>
<StrengthNumber>4.05</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline, 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.</IndicationAndUsage>
<Description>VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C14H1118FN2OS, the molecular weight 273.32, and the following structural formula. VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution. Each mL contains up to 2 mcg of flutemetamol and 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time with the following inactive ingredients: 70 microL ethanol, 9 mg sodium chloride, and 4.98 mg polysorbate 80 (w/v) in 0.014 M aqueous phosphate buffer. The pH of the solution is between 6 and 8.5.</Description>
</NDC>
<NDC>
<NDCCode>42291-067-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42291-067-30) </PackageDescription>
<NDC11Code>42291-0067-30</NDC11Code>
<ProductNDC>42291-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079022</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1).</IndicationAndUsage>
<Description>Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl, USP is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-methyl-3-phenyl-3-( o-tolyoxy)-propylamine hydrochloride. The chemical structure is:. C 17H 21NOHCl M.W. 291.82. Atomoxetine HCl, USP is a white to practically white powder, which has a solubility of 27.8 mg/mL in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>58930-067-04</NDCCode>
<PackageDescription>5 BAG in 1 BOX (58930-067-04) > 30 g in 1 BAG (58930-067-03)</PackageDescription>
<NDC11Code>58930-0067-04</NDC11Code>
<ProductNDC>58930-067</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ahc Phyto Complex Mask</ProprietaryName>
<NonProprietaryName>Adenosine 0.04%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Carver Korea Co.,Ltd</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/30g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>