{
"NDC": [
{
"NDCCode": "66096-693-10",
"PackageDescription": "96.5 g in 1 TUBE (66096-693-10) ",
"NDC11Code": "66096-0693-10",
"ProductNDC": "66096-693",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Skin Healing Cream",
"NonProprietaryName": "Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustifolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana.",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK",
"StrengthNumber": "1; 1; 3; 1; 1; 3; 6; 3; 1",
"StrengthUnit": "[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161115",
"SamplePackage": "N",
"IndicationAndUsage": "USUS: Temporarily relieves scrapes, burns and skin irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-139-10",
"PackageDescription": "96.5 g in 1 TUBE (66096-139-10) ",
"NDC11Code": "66096-0139-10",
"ProductNDC": "66096-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Skin Healing Gel",
"NonProprietaryName": "Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustfolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana.",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK",
"StrengthNumber": "1; 1; 3; 1; 1; 3; 6; 3; 1",
"StrengthUnit": "[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves scrapes, burns and skin irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-341-10",
"PackageDescription": "96.5 g in 1 BOTTLE, PUMP (66096-341-10) ",
"NDC11Code": "66096-0341-10",
"ProductNDC": "66096-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm Venous Aid",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Calendula Officinalis, Echinacea Purpurea, Hamamelis Virginiana, Paeonia Officinalis, Ratanhia.",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT",
"StrengthNumber": "1; 1; 1; 1; 3; 1; 3",
"StrengthUnit": "[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150624",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves minor pain and discomfort due to varicose veins, improving blood vessels tone and relieving inflammation. Also effective in the hemorrhoidal plexus.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-692-10",
"PackageDescription": "96.5 g in 1 PACKAGE (66096-692-10) ",
"NDC11Code": "66096-0692-10",
"ProductNDC": "66096-692",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Muscle And Joint Pain Relief",
"NonProprietaryName": "Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum.",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA FLOWER; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6",
"StrengthUnit": "[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110222",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by osteoarticular trauma, muscle aches, joint stiffness, swelling from injuries, bruises.**. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-695-10",
"PackageDescription": "100 g in 1 TUBE (66096-695-10) ",
"NDC11Code": "66096-0695-10",
"ProductNDC": "66096-695",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Drainage Lymphatic",
"NonProprietaryName": "Aesculus Hipp, Apis Mel, Aranea, Baryta Carb, Equisetum Hyem, Fucus, Fumaria, Juglans Cin, Kali Iod, Kali Mur, Myosotis, Nasturtium, Nat Sulphuricum, Phytolacca, Sarsaparilla, Scrophulara, Secale, Teucrium Scor, Thyroidinum, Vipera.",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "HORSE CHESTNUT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; EQUISETUM HYEMALE; FUCUS VESICULOSUS; FUMARIA OFFICINALIS FLOWERING TOP; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; SMILAX ORNATA ROOT; SCROPHULARIA NODOSA; CLAVICEPS PURPUREA SCLEROTIUM; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, UNSPECIFIED; VIPERA BERUS VENOM",
"StrengthNumber": "4; 4; 14; 14; 3; 3; 2; 2; 2; 2; 2; 2; 2; 2; 2; 3; 6; 2; 10; 6",
"StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141216",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves slow lymphatic drainage. Assists in removing toxins and improves metabolism.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-701-10",
"PackageDescription": "96.5 g in 1 TUBE (66096-701-10) ",
"NDC11Code": "66096-0701-10",
"ProductNDC": "66096-701",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Muscle And Joint Pain Relief Gel",
"NonProprietaryName": "Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea Purp, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum.",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170913",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6",
"StrengthUnit": "[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170913",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by osteoarticular trauma, muscle aches, joint stiffness, swelling from injuries, bruises.**."
},
{
"NDCCode": "13668-693-72",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (13668-693-72) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-693-71) ",
"NDC11Code": "13668-0693-72",
"ProductNDC": "13668-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217100",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260108",
"SamplePackage": "N",
"Description": "Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to off white powder and has a pKa of 5.7. Lamotrigine USP is soluble in dimethylformamide, slightly soluble in acetone, in methanol and in acetic acid, very slightly soluble in acetonitrile. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, stearic acid and sucralose. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "23155-693-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-693-10) ",
"NDC11Code": "23155-0693-10",
"ProductNDC": "23155-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200922",
"EndMarketingDate": "20291031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204467",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200922",
"EndMarketingDatePackage": "20290331",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol tablets are known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone and purified water. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate, povidone and purified water."
},
{
"NDCCode": "37000-693-10",
"PackageDescription": "24 g in 1 TUBE (37000-693-10)",
"NDC11Code": "37000-0693-10",
"ProductNDC": "37000-693",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Extra White Plus Scope Outlast",
"ProprietaryNameSuffix": "Long Lasting Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20090908",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-03-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51293-693-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (51293-693-10) ",
"NDC11Code": "51293-0693-10",
"ProductNDC": "51293-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ECI Pharmaceuticals, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 15 mg, 30 mg, 60 mg, or 100 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "52544-693-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-693-10) ",
"NDC11Code": "52544-0693-10",
"ProductNDC": "52544-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Matzim La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077686",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110328",
"SamplePackage": "N"
},
{
"NDCCode": "60760-693-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (60760-693-10) ",
"NDC11Code": "60760-0693-10",
"ProductNDC": "60760-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065243",
"LabelerName": "St Mary's Medical Park Pharmacy",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190903",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin HCl and other antibacterial drugs, clindamycin HCl capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: 75 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Yellow No. 10, FD&C Green No. 3, and gelatin; 150 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Yellow No. 10, FD&C Green No. 3, D&C Red No. 33, FD&C Blue No. 1, titanium dioxide, and gelatin; 300 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Red No. 33, FD&C Blue No. 1, FD&C Green No. 3, titanium dioxide, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, titanium dioxide, isopropyl alcohol, ammonium hydroxide, n-butyl alcohol, propylene glycol, and simethicone. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "62037-693-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-693-10)",
"NDC11Code": "62037-0693-10",
"ProductNDC": "62037-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077686",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-03"
},
{
"NDCCode": "62584-693-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (62584-693-01) > 10 TABLET, COATED in 1 BLISTER PACK (62584-693-11)",
"NDC11Code": "62584-0693-01",
"ProductNDC": "62584-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120301",
"EndMarketingDate": "20141217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065095",
"LabelerName": "American Health Packaging",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "63187-693-10",
"PackageDescription": "10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-10) ",
"NDC11Code": "63187-0693-10",
"ProductNDC": "63187-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20070802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077557",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "1.Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. 2.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron orally disintegrating tablets is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±)1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Each 4 mg ondansetron orally disintegrating tablet for oral administration contains 4 mg ondansetron, USP. Each 8 mg ondansetron orally disintegrating tablet for oral administration contains 8 mg ondansetron, USP. Each ondansetron orally disintegrating tablet also contains the inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, glycerol distearate, magnesium stearate, mannitol, talc and strawberry flavor. Ondansetron orally disintegrating tablets are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Does not meet USP Disintegration Time. This product disintegrates in approximately 60 seconds."
},
{
"NDCCode": "63304-693-03",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (63304-693-03) ",
"NDC11Code": "63304-0693-03",
"ProductNDC": "63304-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010323",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 ."
},
{
"NDCCode": "63323-693-10",
"PackageDescription": "3 VIAL in 1 CARTON (63323-693-10) / 10 mL in 1 VIAL (63323-693-22) ",
"NDC11Code": "63323-0693-10",
"ProductNDC": "63323-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204674",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140331",
"SamplePackage": "N",
"Description": "Acetylcysteine Solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in purified water. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 to 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. The compound is a white crystalline powder with the molecular formula C 5H 9NO 3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula:. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide, purified water, and hydrochloric acid, if necessary. ACETYLCYSTEINE AS A MUCOLYTIC AGENT."
},
{
"NDCCode": "63739-693-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-693-10) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63739-0693-10",
"ProductNDC": "63739-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140911",
"SamplePackage": "N"
},
{
"NDCCode": "67457-693-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (67457-693-10) > .5 mL in 1 SYRINGE (67457-693-00) ",
"NDC11Code": "67457-0693-10",
"ProductNDC": "67457-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fondaparinux Sodium",
"NonProprietaryName": "Fondaparinux Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160609",
"EndMarketingDate": "20190131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021345",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "FONDAPARINUX SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160609",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "68382-693-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-693-30) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68382-0693-30",
"ProductNDC": "68382-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211747",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250710",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine is indicated for: 1 Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures .",
"Description": "Oxcarbazepine Tablet USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine USP is a light orange to creamish white or off-white powder. It is sparingly soluble in chloroform. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, polyethylene glycol, hypromellose, iron oxide yellow, iron oxide red, microcrystalline cellulose, magnesium stearate, titanium dioxide and talc. FDA approved organic impurities acceptance criteria differs from USP test."
},
{
"NDCCode": "71919-693-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-693-10) ",
"NDC11Code": "71919-0693-10",
"ProductNDC": "71919-693",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uranium Nitricum",
"NonProprietaryName": "Uranyl Nitrate Hexahydrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "73352-693-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (73352-693-10) ",
"NDC11Code": "73352-0693-10",
"ProductNDC": "73352-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Evexithroid",
"NonProprietaryName": "Levothyroxine And Liothyronine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251012",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Trifluent Pharma, LLC",
"SubstanceName": "LEVOTHYROXINE; LIOTHYRONINE",
"StrengthNumber": "9.5; 2.25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251012",
"SamplePackage": "N",
"IndicationAndUsage": "EvexiTHROID (Thyroid Tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.",
"Description": "EvexiTHROID (Thyroid Tablets, USP) (Thyroid Tablets, USP) has not been approved by FDA as a new drug.for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. EvexiTHROID (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). EvexiTHROID may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below."
},
{
"NDCCode": "16714-693-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (16714-693-01) ",
"NDC11Code": "16714-0693-01",
"ProductNDC": "16714-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081007",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "16714-693-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-693-02) ",
"NDC11Code": "16714-0693-02",
"ProductNDC": "16714-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081007",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "16729-693-09",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (16729-693-09) ",
"NDC11Code": "16729-0693-09",
"ProductNDC": "16729-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218872",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260226",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone ( 1.1). , 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1). , 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2). , 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4). , 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). .",
"Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3,and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide, green and black ink. The 2.5 mg contains gelatin, iron oxide black, titanium dioxide, green and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, green and black ink. The 15 mg capsule shell contains gelatin, iron oxide red, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The black imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. The green imprinting ink contains FD&C Blue #2 aluminum lake, iron oxide yellow, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "21695-693-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-693-30)",
"NDC11Code": "21695-0693-30",
"ProductNDC": "21695-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20001130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065062",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.",
"Description": "Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is [4S-(4α,5aα,12aα)]-4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2- naphthacenecarboxamide monohydrochloride. Its structural formula is represented below. C23H27N3O7.HCl M.W. 493.95. Each Minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and corn starch. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin, titanium dioxide and black iron oxide in the edible ink. The 75 mg and 100 mg capsule shells also contain: black iron oxide."
},
{
"NDCCode": "31722-693-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (31722-693-60) ",
"NDC11Code": "31722-0693-60",
"ProductNDC": "31722-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulfate",
"NonProprietaryName": "Dextromethorphan Hydrobromide And Quinidine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218426",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240828",
"SamplePackage": "N",
"IndicationAndUsage": "Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.",
"Description": "Dextromethorphan hydrobromide and quinidine sulfate capsules are an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination. Dextromethorphan hydrobromide is the pharmacologically active ingredient of dextromethorphan hydrobromide and quinidine sulfate capsules that acts on the central nervous system (CNS). The chemical name of dextromethorphan hydrobromide is morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the molecular formula C 18H 25NOHBrH 2O with a molecular weight of 370.33. The structural formula is:. Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in dextromethorphan hydrobromide and quinidine sulfate capsules to increase the systemic bioavailability of dextromethorphan. The chemical name of quinidine sulfate is cinchonan-9-o1, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the molecular formula of (C 20H 24N 2O 2)2H 2SO 42H 2O with a molecular weight of 782.96. The structural formula is:. The combination product, dextromethorphan hydrobromide and quinidine sulfate capsules, is a white to off-white powder. Dextromethorphan hydrobromide and quinidine sulfate capsules are available for oral use, which contains 20 mg dextromethorphan hydrobromide, USP and 10 mg quinidine sulfate, USP. The active ingredients are dextromethorphan hydrobromide, USP and quinidine sulfate, USP. Inactive ingredients in the capsule are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin and titanium dioxide. The black imprinting ink contains ammonia solution, iron oxide black, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "41226-693-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41226-693-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "41226-0693-24",
"ProductNDC": "41226-693",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Acetaminophen, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210511",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kroger Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 5; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210511",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves common cold/flu symptoms:, 2 nasal congestion, 3 cough due to minor throat & bronchial irritation, 4 sore throat, 5 headache, 6 minor aches & pains, 7 fever."
},
{
"NDCCode": "43353-693-06",
"PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-693-06)",
"NDC11Code": "43353-0693-06",
"ProductNDC": "43353-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065211",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Azithromycin tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R, 11R,12S,13S,14R) -13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Each azithromycin tablet, intended for oral administration, contains azithromycin monohydrate equivalent to either 250 mg or 500 mg of azithromycin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "43353-693-87",
"PackageDescription": "2400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-693-87)",
"NDC11Code": "43353-0693-87",
"ProductNDC": "43353-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065211",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Azithromycin tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R, 11R,12S,13S,14R) -13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Each azithromycin tablet, intended for oral administration, contains azithromycin monohydrate equivalent to either 250 mg or 500 mg of azithromycin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum."
}
]
}
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<PackageDescription>96.5 g in 1 TUBE (66096-693-10) </PackageDescription>
<NDC11Code>66096-0693-10</NDC11Code>
<ProductNDC>66096-693</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Skin Healing Cream</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustifolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana.</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 1; 3; 6; 3; 1</StrengthNumber>
<StrengthUnit>[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USUS: Temporarily relieves scrapes, burns and skin irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-139-10</NDCCode>
<PackageDescription>96.5 g in 1 TUBE (66096-139-10) </PackageDescription>
<NDC11Code>66096-0139-10</NDC11Code>
<ProductNDC>66096-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Skin Healing Gel</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustfolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana.</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK</SubstanceName>
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<StrengthUnit>[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves scrapes, burns and skin irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
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<NDC>
<NDCCode>66096-341-10</NDCCode>
<PackageDescription>96.5 g in 1 BOTTLE, PUMP (66096-341-10) </PackageDescription>
<NDC11Code>66096-0341-10</NDC11Code>
<ProductNDC>66096-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm Venous Aid</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Calendula Officinalis, Echinacea Purpurea, Hamamelis Virginiana, Paeonia Officinalis, Ratanhia.</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 3; 1; 3</StrengthNumber>
<StrengthUnit>[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves minor pain and discomfort due to varicose veins, improving blood vessels tone and relieving inflammation. Also effective in the hemorrhoidal plexus.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
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<NDC>
<NDCCode>66096-692-10</NDCCode>
<PackageDescription>96.5 g in 1 PACKAGE (66096-692-10) </PackageDescription>
<NDC11Code>66096-0692-10</NDC11Code>
<ProductNDC>66096-692</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Muscle And Joint Pain Relief</ProprietaryName>
<NonProprietaryName>Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum.</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA FLOWER; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by osteoarticular trauma, muscle aches, joint stiffness, swelling from injuries, bruises.**. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-695-10</NDCCode>
<PackageDescription>100 g in 1 TUBE (66096-695-10) </PackageDescription>
<NDC11Code>66096-0695-10</NDC11Code>
<ProductNDC>66096-695</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Drainage Lymphatic</ProprietaryName>
<NonProprietaryName>Aesculus Hipp, Apis Mel, Aranea, Baryta Carb, Equisetum Hyem, Fucus, Fumaria, Juglans Cin, Kali Iod, Kali Mur, Myosotis, Nasturtium, Nat Sulphuricum, Phytolacca, Sarsaparilla, Scrophulara, Secale, Teucrium Scor, Thyroidinum, Vipera.</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>HORSE CHESTNUT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; EQUISETUM HYEMALE; FUCUS VESICULOSUS; FUMARIA OFFICINALIS FLOWERING TOP; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; SMILAX ORNATA ROOT; SCROPHULARIA NODOSA; CLAVICEPS PURPUREA SCLEROTIUM; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, UNSPECIFIED; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>4; 4; 14; 14; 3; 3; 2; 2; 2; 2; 2; 2; 2; 2; 2; 3; 6; 2; 10; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves slow lymphatic drainage. Assists in removing toxins and improves metabolism.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-701-10</NDCCode>
<PackageDescription>96.5 g in 1 TUBE (66096-701-10) </PackageDescription>
<NDC11Code>66096-0701-10</NDC11Code>
<ProductNDC>66096-701</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Muscle And Joint Pain Relief Gel</ProprietaryName>
<NonProprietaryName>Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea Purp, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum.</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170913</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by osteoarticular trauma, muscle aches, joint stiffness, swelling from injuries, bruises.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-693-72</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (13668-693-72) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-693-71) </PackageDescription>
<NDC11Code>13668-0693-72</NDC11Code>
<ProductNDC>13668-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217100</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to off white powder and has a pKa of 5.7. Lamotrigine USP is soluble in dimethylformamide, slightly soluble in acetone, in methanol and in acetic acid, very slightly soluble in acetonitrile. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, stearic acid and sucralose. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>23155-693-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-693-10) </PackageDescription>
<NDC11Code>23155-0693-10</NDC11Code>
<ProductNDC>23155-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200922</StartMarketingDate>
<EndMarketingDate>20291031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204467</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200922</StartMarketingDatePackage>
<EndMarketingDatePackage>20290331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol tablets are known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone and purified water. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate, povidone and purified water.</Description>
</NDC>
<NDC>
<NDCCode>37000-693-10</NDCCode>
<PackageDescription>24 g in 1 TUBE (37000-693-10)</PackageDescription>
<NDC11Code>37000-0693-10</NDC11Code>
<ProductNDC>37000-693</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Extra White Plus Scope Outlast</ProprietaryName>
<ProprietaryNameSuffix>Long Lasting Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20090908</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51293-693-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (51293-693-10) </PackageDescription>
<NDC11Code>51293-0693-10</NDC11Code>
<ProductNDC>51293-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ECI Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 15 mg, 30 mg, 60 mg, or 100 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>52544-693-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-693-10) </PackageDescription>
<NDC11Code>52544-0693-10</NDC11Code>
<ProductNDC>52544-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Matzim La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077686</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-693-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (60760-693-10) </PackageDescription>
<NDC11Code>60760-0693-10</NDC11Code>
<ProductNDC>60760-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065243</ApplicationNumber>
<LabelerName>St Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin HCl and other antibacterial drugs, clindamycin HCl capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Inactive ingredients: 75 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Yellow No. 10, FD&C Green No. 3, and gelatin; 150 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Yellow No. 10, FD&C Green No. 3, D&C Red No. 33, FD&C Blue No. 1, titanium dioxide, and gelatin; 300 mg - lactose monohydrate, corn starch, magnesium stearate, talc, D&C Red No. 33, FD&C Blue No. 1, FD&C Green No. 3, titanium dioxide, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, titanium dioxide, isopropyl alcohol, ammonium hydroxide, n-butyl alcohol, propylene glycol, and simethicone. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>62037-693-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-693-10)</PackageDescription>
<NDC11Code>62037-0693-10</NDC11Code>
<ProductNDC>62037-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077686</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>62584-693-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (62584-693-01) > 10 TABLET, COATED in 1 BLISTER PACK (62584-693-11)</PackageDescription>
<NDC11Code>62584-0693-01</NDC11Code>
<ProductNDC>62584-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<EndMarketingDate>20141217</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065095</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-693-10</NDCCode>
<PackageDescription>10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-693-10) </PackageDescription>
<NDC11Code>63187-0693-10</NDC11Code>
<ProductNDC>63187-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077557</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. 2.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron orally disintegrating tablets is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±)1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Each 4 mg ondansetron orally disintegrating tablet for oral administration contains 4 mg ondansetron, USP. Each 8 mg ondansetron orally disintegrating tablet for oral administration contains 8 mg ondansetron, USP. Each ondansetron orally disintegrating tablet also contains the inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, glycerol distearate, magnesium stearate, mannitol, talc and strawberry flavor. Ondansetron orally disintegrating tablets are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Does not meet USP Disintegration Time. This product disintegrates in approximately 60 seconds.</Description>
</NDC>
<NDC>
<NDCCode>63304-693-03</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (63304-693-03) </PackageDescription>
<NDC11Code>63304-0693-03</NDC11Code>
<ProductNDC>63304-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. : 1 C 18H 33ClN 2O 5SHCl M.W. 461.45 .</Description>
</NDC>
<NDC>
<NDCCode>63323-693-10</NDCCode>
<PackageDescription>3 VIAL in 1 CARTON (63323-693-10) / 10 mL in 1 VIAL (63323-693-22) </PackageDescription>
<NDC11Code>63323-0693-10</NDC11Code>
<ProductNDC>63323-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204674</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Acetylcysteine Solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in purified water. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 to 7.5). Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. The compound is a white crystalline powder with the molecular formula C 5H 9NO 3S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula:. This product contains the following inactive ingredients: disodium edetate, sodium hydroxide, purified water, and hydrochloric acid, if necessary. ACETYLCYSTEINE AS A MUCOLYTIC AGENT.</Description>
</NDC>
<NDC>
<NDCCode>63739-693-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-693-10) > 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0693-10</NDC11Code>
<ProductNDC>63739-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-693-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (67457-693-10) > .5 mL in 1 SYRINGE (67457-693-00) </PackageDescription>
<NDC11Code>67457-0693-10</NDC11Code>
<ProductNDC>67457-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fondaparinux Sodium</ProprietaryName>
<NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160609</StartMarketingDate>
<EndMarketingDate>20190131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021345</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160609</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-693-30</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-693-30) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68382-0693-30</NDC11Code>
<ProductNDC>68382-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211747</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine is indicated for: 1 Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures .</IndicationAndUsage>
<Description>Oxcarbazepine Tablet USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine USP is a light orange to creamish white or off-white powder. It is sparingly soluble in chloroform. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, polyethylene glycol, hypromellose, iron oxide yellow, iron oxide red, microcrystalline cellulose, magnesium stearate, titanium dioxide and talc. FDA approved organic impurities acceptance criteria differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>71919-693-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-693-10) </PackageDescription>
<NDC11Code>71919-0693-10</NDC11Code>
<ProductNDC>71919-693</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uranium Nitricum</ProprietaryName>
<NonProprietaryName>Uranyl Nitrate Hexahydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73352-693-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73352-693-10) </PackageDescription>
<NDC11Code>73352-0693-10</NDC11Code>
<ProductNDC>73352-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evexithroid</ProprietaryName>
<NonProprietaryName>Levothyroxine And Liothyronine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251012</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Trifluent Pharma, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE; LIOTHYRONINE</SubstanceName>
<StrengthNumber>9.5; 2.25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EvexiTHROID (Thyroid Tablets, USP) are indicated: 1 As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). , 2 As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>EvexiTHROID (Thyroid Tablets, USP) (Thyroid Tablets, USP) has not been approved by FDA as a new drug.for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. EvexiTHROID (Thyroid Tablets, USP) contains both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine). T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis. They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) for each 60 mg of the labeled content of thyroid. The inactive ingredients are calcium stearate, colloidal silicon dioxide, mannitol and microcrystalline cellulose. Contains no ingredient made from a gluten containing grain (wheat, barley, rye). EvexiTHROID may have a strong, characteristic odor due to its thyroid extract component. The structural formulas are below.</Description>
</NDC>
<NDC>
<NDCCode>16714-693-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16714-693-01) </PackageDescription>
<NDC11Code>16714-0693-01</NDC11Code>
<ProductNDC>16714-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16714-693-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-693-02) </PackageDescription>
<NDC11Code>16714-0693-02</NDC11Code>
<ProductNDC>16714-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16729-693-09</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (16729-693-09) </PackageDescription>
<NDC11Code>16729-0693-09</NDC11Code>
<ProductNDC>16729-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenalidomide</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218872</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone ( 1.1). , 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1). , 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2). , 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3). , 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4). , 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5). .</IndicationAndUsage>
<Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2 H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C 13H 13N 3O 3,and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide, green and black ink. The 2.5 mg contains gelatin, iron oxide black, titanium dioxide, green and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, green and black ink. The 15 mg capsule shell contains gelatin, iron oxide red, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, green and black ink. The black imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. The green imprinting ink contains FD&C Blue #2 aluminum lake, iron oxide yellow, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-693-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-693-30)</PackageDescription>
<NDC11Code>21695-0693-30</NDC11Code>
<ProductNDC>21695-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065062</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is [4S-(4α,5aα,12aα)]-4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2- naphthacenecarboxamide monohydrochloride. Its structural formula is represented below. C23H27N3O7.HCl M.W. 493.95. Each Minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and corn starch. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin, titanium dioxide and black iron oxide in the edible ink. The 75 mg and 100 mg capsule shells also contain: black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-693-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (31722-693-60) </PackageDescription>
<NDC11Code>31722-0693-60</NDC11Code>
<ProductNDC>31722-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide And Quinidine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218426</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.</IndicationAndUsage>
<Description>Dextromethorphan hydrobromide and quinidine sulfate capsules are an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination. Dextromethorphan hydrobromide is the pharmacologically active ingredient of dextromethorphan hydrobromide and quinidine sulfate capsules that acts on the central nervous system (CNS). The chemical name of dextromethorphan hydrobromide is morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the molecular formula C 18H 25NOHBrH 2O with a molecular weight of 370.33. The structural formula is:. Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in dextromethorphan hydrobromide and quinidine sulfate capsules to increase the systemic bioavailability of dextromethorphan. The chemical name of quinidine sulfate is cinchonan-9-o1, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the molecular formula of (C 20H 24N 2O 2)2H 2SO 42H 2O with a molecular weight of 782.96. The structural formula is:. The combination product, dextromethorphan hydrobromide and quinidine sulfate capsules, is a white to off-white powder. Dextromethorphan hydrobromide and quinidine sulfate capsules are available for oral use, which contains 20 mg dextromethorphan hydrobromide, USP and 10 mg quinidine sulfate, USP. The active ingredients are dextromethorphan hydrobromide, USP and quinidine sulfate, USP. Inactive ingredients in the capsule are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin and titanium dioxide. The black imprinting ink contains ammonia solution, iron oxide black, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>41226-693-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41226-693-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41226-0693-24</NDC11Code>
<ProductNDC>41226-693</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves common cold/flu symptoms:, 2 nasal congestion, 3 cough due to minor throat & bronchial irritation, 4 sore throat, 5 headache, 6 minor aches & pains, 7 fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43353-693-06</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-693-06)</PackageDescription>
<NDC11Code>43353-0693-06</NDC11Code>
<ProductNDC>43353-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065211</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R, 11R,12S,13S,14R) -13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Each azithromycin tablet, intended for oral administration, contains azithromycin monohydrate equivalent to either 250 mg or 500 mg of azithromycin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>43353-693-87</NDCCode>
<PackageDescription>2400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-693-87)</PackageDescription>
<NDC11Code>43353-0693-87</NDC11Code>
<ProductNDC>43353-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065211</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin tablets, USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R, 11R,12S,13S,14R) -13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Each azithromycin tablet, intended for oral administration, contains azithromycin monohydrate equivalent to either 250 mg or 500 mg of azithromycin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
</NDCList>